COVID-19 (Coronavirus Disease 2019)NCT07072793
A US Study to Look at Loss of Work and Healthcare Costs for People Affected With Mild-to-moderate COVID 19 Who Have High Chances of the Disease Becoming Severe
An observational study of COVID-19 (Coronavirus Disease 2019), run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to understand how COVID-19 affects people's ability to work and to calculate the costs associated with loss of work. The study compares two groups of participants who are confirmed to have mild-to moderated COVID-19 and who have high chances of the disease becoming severe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 (Coronavirus Disease 2019)
- What is being tested?
- nirmatrelvir-ritonavir
- How many people
- 131,005 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2024to 15 Nov 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: retrospective cohort study of adult, high-risk patients diagnosed with COVID-19 using data from the Merative™ MarketScan® Commercial, Medicare, and Health and Productivity Management (HPM) Databases. The index date for both cohorts will be the date of the first COVID-19 diagnosis and patients will be followed over a 6-month pre-period and variable post-period. The post-period will be a minimum of 30 days to allow patients the opportunity to experience the primary study outcomes of work loss days (absence, STD, and LTD) along with associated indirect costs.
Who may be able to join
- >1 non-diagnostic2 outpatient medical claim in the MarketScan Commercial or Medicare Database with the International Classification of Diseases, 10th Revision (ICD-10) diagnosis code for COVID-19 (U071) between December 16, 2021 (5 days prior to the date of emergency use authorization of NMV/r) and December 1, 2022 (30 days prior to the end of available HPM data); the date of the earliest qualifying claim is the index date.
- Primary beneficiary on their insurance policy (i.e., eligible for inclusion in the MarketScan HPM Database)
- >6 months of continuous enrollment with medical and pharmacy benefits in the MarketScan Commercial or Medicare Database before the index date (baseline period)
- >30 days of continuous enrollment with medical and pharmacy benefits in the MarketScan Commercial or Medicare Database after and including the index date (minimum follow-up period)
- Treated cohort ONLY: ≥1 claim for Paxlovid within 5 days of index (index date and next 4 days)
Who cannot join
- Evidence of death on the index date or the following day
- Any inpatient admission on the index date or the following day
- ≥1 inpatient claim with a COVID-19 diagnosis in any position on the claim during the 30 days before the index date
- >1 non-diagnostic claim with a diagnosis code for stage 4 or stage 5 chronic kidney disease, end stage renal disease, or a procedure code for dialysis, during the baseline period or on the index date
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Work Productivity Losses in the United States Among High-risk Patients With COVID-19 During Acute and Longer-term Follow-up in an Omicron Predominant Period (PULSE-US)
The purpose of this study is to understand how COVID-19 affects people's ability to work and to calculate the costs associated with loss of work.
The study compares two groups of participants who are confirmed to have mild-to moderated COVID-19 and who have high chances of the disease becoming severe.
Read more
The two groups are:
People who took the antiviral medication nirmatrelvir-ritonavir (also called Paxlovid) People who were eligible to receive antiviral medication but did not receive any.
The participants will be selected from various health databases in the US between June 2021 and December 2022.
The main goals are:
To look at the characteristics of both groups of participants with COVID-19. To measure how much work these participants missed, including days off and sick leave, and the costs associated with this work loss.
To compare work loss and costs between the two groups of participants, considering differences in their clinical and demographic characteristics.
The study will evaluate at least 30 days of data from participants after they are confirmed to have COVID-19
- Conditions
- COVID-19 (Coronavirus Disease 2019)
- Being tested
- nirmatrelvir-ritonavir
- Keywords
- SARS Coronavirus, SARS Virus, SARS-CoV, SARS-CoV-1, Paxlovid, omicron
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nirmatrelvir-ritonavirDrug
Also called Paxlovid
Participants with confirmed diagnosis of Covid-19 and with mild to moderate symptoms at high-risk for progressing to severe disease
| Study group | Role | What they receive |
|---|---|---|
| Treated cohort: nirmatrelvir-ritonavir | Participants with confirmed diagnosis of Covid-19 and with mild to moderate symptoms at high-risk for progressing to severe disease. Receives: Drug: nirmatrelvir-ritonavir | |
| Untreated cohort: not receiving any antiviral treatment | Participants with confirmed diagnosis of Covid-19 and with mild to moderate symptoms at high-risk for progressing to severe disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants According to Age Group: Unmatched Participants
Age group was categorized into following categories: 18-29 years, 30-39 years, 40-49 years, 50-64 years and 65-74 years. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Age Group: Matched Participants
Age group was categorized into following categories: 18-29 years, 30-39 years, 40-49 years, 50-64 years and 65-74 years. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Sex: Unmatched Participants
Sex was categorized as: female and male. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Sex: Matched Participants
Sex was categorized as: female and male. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Region of Residence: Unmatched Participants
Region of residence was categorized into following categories: Northeast, North Central, South, West, and other/ missing. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Region of Residence: Matched Participants
Region of residence was categorized into following categories: Northeast, North Central, South, West and other/ missing. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Payer Type: Unmatched Participants
Payer type was categorized as: commercial and medicare. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Payer Type: Matched Participants
Payer type was categorized as: commercial and medicare. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Insurance Plan Type: Unmatched Participants
Insurance plan type was categorized into following categories: comprehensive/indemnity, exclusive/preferred provider organization (EPO/PPO), point of service capitation (POS) with or without capitation, health maintenance organization (HMO), consumer driven/ high-deductible health plan (CDHP/HDHP) and missing/unknown. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Insurance Plan Type: Matched Participants
Insurance plan type was categorized into following categories: comprehensive/indemnity, EPO/PPO, POS with or without capitation, HMO, CDHP/HDHP and missing/unknown. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Industry Type: Unmatched Participants
Industry type was categorized into following categories: finance/insurance/real estate, manufacturing (durable/non-durable goods), retail trade, services, transportation/communications/utilities and other. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Industry Type: Matched Participants
Industry type was categorized into following categories: finance/insurance/real estate, manufacturing (durable/non-durable goods), retail trade, services, transportation/communications/utilities and other. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Quarter (Q) of Index Year: Unmatched Participants
Quarter of index year was categorized into following categories: Q4 2021, Q1 2022, Q2 2022, Q3 2022 and Q4 2022. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Quarter of Index Year: Matched Participants
Quarter of index year was categorized into following categories: Q4 2021, Q1 2022, Q2 2022, Q3 2022 and Q4 2022. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Mean Duration of Follow-up: Unmatched Participants
Duration of follow-up was defined as number of months from (and including) the index date to the end of participants variable-length follow-up period. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Mean Duration of Follow-up: Matched Participants
Duration of follow-up was defined as number of months from (and including) the index date to the end of participants variable-length follow-up period. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Mean Elixhauser Comorbidity Index (ECI): Unmatched Participants
ECI was a measure of comorbidity based on ICD-10 codes. ECI score range was from 0-30. A higher score indicated more comorbidity. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Mean ECI: Matched Participants
ECI was a measure of comorbidity based on ICD-10 codes. ECI score range was from 0-30. A higher score indicated more comorbidity. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Mean Charlson Comorbidity Index (CCI): Unmatched Participants
CCI based on various comorbid conditions such as cerebrovascular disease, chronic pulmonary disease, congestive heart failure, dementia, mild/moderate diabetes, diabetes with chronic complications, hemiplegia/paraplegia, human immunodeficiency virus(HIV), mild liver disease, moderate/severe liver disease, malignancy, metastatic solid tumor, myocardial infarction, peptic ulcer disease, peripheral vascular disease, renal disease, rheumatologic disease was reported. CCI score range was from 0 to 33, where "0"= low comorbid condition and "33"= high comorbid condition, higher scores indicated more comorbidity. Index date was the date of first COVID-19 diagnosis. Data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Mean CCI: Matched Participants
CCI based on various comorbid conditions such as cerebrovascular disease, chronic pulmonary disease, congestive heart failure, dementia, mild/moderate diabetes, diabetes with chronic complications, hemiplegia/paraplegia, HIV, mild liver disease, moderate/severe liver disease, malignancy, metastatic solid tumor, myocardial infarction, peptic ulcer disease, peripheral vascular disease, renal disease, rheumatologic disease was reported. CCI score range was from 0 to 33, where "0"= low comorbid condition and "33"= high comorbid condition, higher scores indicated more comorbidity. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Comorbidities: Unmatched Participants
Comorbidities were categorized into following categories: cancer (current or history of), cardio/cerebrovascular disease, chronic kidney disease, chronic liver disease, diabetes mellitus, immunocompromised status, lung disease or tuberculosis, neurodevelopmental disorder/complex condition, overweight/obesity or smoking and pregnancy. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category. Participant can have more than 1 comorbidity.
Measured: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Comorbidities: Matched Participants
Comorbidities were categorized into following categories: cancer (current or history of), cardio/cerebrovascular disease, chronic kidney disease, chronic liver disease, diabetes mellitus, immunocompromised status, lung disease or tuberculosis, neurodevelopmental disorder/complex condition, overweight/obesity or smoking and pregnancy. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category. Participant can have more than 1 comorbidity.
Measured: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of High-risk Conditions Per Participant: Unmatched Participants
High risk conditions included cancer, cerebrovascular or peripheral vascular disease, chronic lung disease, chronic liver disease, cystic fibrosis, dementia, diabetes, disability, heart conditions, HIV, hypertension, immunocompromised state(primary immunodeficiencies, prolonged use of corticosteroids or other immunosuppressive medications, and other immunocompromised state), mental health conditions(mood disorder or schizophrenia), overweight or obesity, physical inactivity, pregnancy(current or recent), sickle cell disease or thalassemia, smoking (current or former), solid organ or blood stem cell transplant, substance use disorder, tuberculosis. Index date=date of first COVID-19 diagnosis. Data was reported for unmatched participants, they were further sub-grouped on basis of outcome of COVID-19: eligible for absence from work, short term disability, long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of High-risk Conditions Per Participant: Matched Participants
High risk conditions included cancer, cerebrovascular or peripheral vascular disease, chronic lung disease, chronic liver disease, cystic fibrosis, dementia, diabetes, disability, heart conditions, HIV, hypertension, immunocompromised state (primary immunodeficiencies, prolonged use of corticosteroids or other immunosuppressive medications, and other immunocompromised state), mental health conditions (mood disorder or schizophrenia), overweight or obesity, physical inactivity, pregnancy(current or recent), sickle cell disease or thalassemia, smoking (current or former), solid organ or blood stem cell transplant, substance use disorder, tuberculosis. Index date=date of first COVID-19 diagnosis. Data was reported for matched participants, they were further sub-grouped on basis of outcome of COVID-19: eligible for absence from work, short term disability, long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to COVID-19 Vaccination Status: Unmatched Participant
Number of participants with >=1 claim for a COVID-19 vaccination during the pre-period was reported in this outcome measure. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to COVID-19 Vaccination Status: Matched Participant
Number of participants with >=1 claim for a COVID-19 vaccination during the pre-period was reported in this outcome measure. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants With One or More Prior Hospitalization: Unmatched Participants
Prior hospitalization indicated participants who had one or more inpatients visits in the pre-period. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants With One or More Prior Hospitalization: Matched Participants
Prior hospitalization indicated participants who had one or more inpatients visits in the pre-period. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants With One or More Prior Emergency Room (ER) Visit: Unmatched Participants
Prior ER visit indicates participants who had one or more ER visits in pre-period. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants With One or More Prior Emergency Room (ER) Visit: Matched Participants
Prior ER visit indicates participants who had one or more ER visits in pre-period. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Measured: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants With Presence of Any Absence Records: Matched Participants
Number of participants with presence of any absence records was reported in this outcome measure. Index date was the date of first COVID-19 diagnosis.
Measured: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Mean Number of Absence Days Per Participant Per Month (PPPM): Matched Participants
In this outcome measure mean number of absence days PPPM was reported. Index date was the date of first COVID-19 diagnosis.
Measured: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Type for Absence Claim: Matched Participants
Absence days was reported by absence type: sick, disability and recreational absence. Sick, disability and recreational absence were the leaves which participants took during the study period. Sick absence referred to the time away from work due to an employee's own illness or medical condition, this may be also used for bereavement, caring for a family member with a serious health condition, adoption-related medical needs. Disability absence was recorded when an employee was unable to work due to a short-term or long-term disability. Recreational absence referred to the time off taken for non-medical, personal reasons, such as vacation, personal leave, leisure, or wellness days. Index date was the date of first COVID-19 diagnosis. One participant may have more than one type of absence claim.
Measured: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Mean Cost of Absence Days: Matched Participants
Estimated sum of wages associated with absence days was calculated as daily wage multiplied by absence days was reported PPPM in this outcome measure. Index date was the date of first COVID-19 diagnosis.
Measured: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants With Any Short Term Disability (STD) Claim: Matched Participants
Number of participants with presence of any STD claim was reported in this outcome measure. Index date was the date of first COVID-19 diagnosis.
Measured: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Mean Number of STD Days PPPM: Matched Participants
In this outcome measure mean number of STD days PPPM was reported. Index date was the date of first COVID-19 diagnosis.
Measured: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Reason for STD Claim: Matched Participants
Reasons for STD were classified as COVID-19 related or non-COVID-19 related or missing/unknown. Index date was the date of first COVID-19 diagnosis.
Measured: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Mean Cost of STD Days: Matched Participants
Estimated sum of wages associated with absence days STD claim was calculated as 70 percentage (%) of daily wage multiplied by STD days was reported PPPM in this outcome measure. Index date was the date of first COVID-19 diagnosis.
Measured: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants With Any Long Term Disability (LTD) Claim: Matched Participants
Number of participants with presence of any LTD claim was reported in this outcome measure. Index date was the date of first COVID-19 diagnosis.
Measured: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Mean Number of LTD Days PPPM: Matched Participants
In this outcome measure mean number of LTD days PPPM was reported. Index date was the date of first COVID-19 diagnosis.
Measured: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of Participants According to Reason for LTD Claim: Matched Participants
Reasons for LTD were classified as COVID-19 related or non-COVID-19 related or missing/unknown. Index date was the date of first COVID-19 diagnosis.
Measured: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Mean Cost of LTD Days: Matched Participants
Estimated sum of wages associated with absence days LTD claim was calculated as 70 percent (%) of daily wage multiplied by LTD days was reported PPPM in this outcome measure. Index date was the date of first COVID-19 diagnosis.
Measured: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start31 Oct 2024
- Primary completion15 Nov 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19 (Coronavirus Disease 2019)Studies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 131,005 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072793
- Sponsor's protocol ID
- C4671066
- Status last verified
- Jan 2026
- First submitted
- 15 Nov 2024
- Last updated
- 9 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Work Productivity Losses in the United States Among High-risk Patients With COVID-19 During Acute and Longer-term Follow-up in an Omicron Predominant Period (PULSE-US)
- ClinicalTrials.gov ID
- NCT07072793
- Acronym / sponsor ID
- C4671066
- Conditions
- COVID-19 (Coronavirus Disease 2019)
- Keywords
- SARS Coronavirus, SARS Virus, SARS-CoV, SARS-CoV-1, Paxlovid, omicron
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131,005 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 18 Jul 2025 (actual)
- Results
- Posted 12 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to understand how COVID-19 affects people's ability to work and to calculate the costs associated with loss of work.
The study compares two groups of participants who are confirmed to have mild-to moderated COVID-19 and who have high chances of the disease becoming severe.
The two groups are:
People who took the antiviral medication nirmatrelvir-ritonavir (also called Paxlovid) People who were eligible to receive antiviral medication but did not receive any.
The participants will be selected from various health databases in the US between June 2021 and December 2022.
The main goals are:
To look at the characteristics of both groups of participants with COVID-19. To measure how much work these participants missed, including days off and sick leave, and the costs associated with this work loss.
To compare work loss and costs between the two groups of participants, considering differences in their clinical and demographic characteristics.
The study will evaluate at least 30 days of data from participants after they are confirmed to have COVID-19
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated cohort: nirmatrelvir-ritonavir | – | Drug: nirmatrelvir-ritonavirParticipants with confirmed diagnosis of Covid-19 and with mild to moderate symptoms at high-risk for progressing to severe disease. |
| Untreated cohort: not receiving any antiviral treatment | – | –Participants with confirmed diagnosis of Covid-19 and with mild to moderate symptoms at high-risk for progressing to severe disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- retrospective cohort study of adult, high-risk patients diagnosed with COVID-19 using data from the Merative™ MarketScan® Commercial, Medicare, and Health and Productivity Management (HPM) Databases. The index date for both cohorts will be the date of the first COVID-19 diagnosis and patients will be followed over a 6-month pre-period and variable post-period. The post-period will be a minimum of 30 days to allow patients the opportunity to experience the primary study outcomes of work loss days (absence, STD, and LTD) along with associated indirect costs.
Key inclusion criteria (5 listed)
- >1 non-diagnostic2 outpatient medical claim in the MarketScan Commercial or Medicare Database with the International Classification of Diseases, 10th Revision (ICD-10) diagnosis code for COVID-19 (U071) between December 16, 2021 (5 days prior to the date of emergency use authorization of NMV/r) and December 1, 2022 (30 days prior to the end of available HPM data); the date of the earliest qualifying claim is the index date.
- Primary beneficiary on their insurance policy (i.e., eligible for inclusion in the MarketScan HPM Database)
- >6 months of continuous enrollment with medical and pharmacy benefits in the MarketScan Commercial or Medicare Database before the index date (baseline period)
- >30 days of continuous enrollment with medical and pharmacy benefits in the MarketScan Commercial or Medicare Database after and including the index date (minimum follow-up period)
- Treated cohort ONLY: ≥1 claim for Paxlovid within 5 days of index (index date and next 4 days)
Key exclusion criteria (4 listed)
- Evidence of death on the index date or the following day
- Any inpatient admission on the index date or the following day
- ≥1 inpatient claim with a COVID-19 diagnosis in any position on the claim during the 30 days before the index date
- >1 non-diagnostic claim with a diagnosis code for stage 4 or stage 5 chronic kidney disease, end stage renal disease, or a procedure code for dialysis, during the baseline period or on the index date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nirmatrelvir-ritonavirAlso: PaxlovidParticipants with confirmed diagnosis of Covid-19 and with mild to moderate symptoms at high-risk for progressing to severe disease | Drug | Treated cohort: nirmatrelvir-ritonavir |
Primary outcome
Number of Participants According to Age Group: Unmatched Participants
Time frame: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Age group was categorized into following categories: 18-29 years, 30-39 years, 40-49 years, 50-64 years and 65-74 years. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Number of Participants According to Age Group: Matched Participants
Time frame: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Age group was categorized into following categories: 18-29 years, 30-39 years, 40-49 years, 50-64 years and 65-74 years. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Number of Participants According to Sex: Unmatched Participants
Time frame: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Sex was categorized as: female and male. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Number of Participants According to Sex: Matched Participants
Time frame: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Sex was categorized as: female and male. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Number of Participants According to Region of Residence: Unmatched Participants
Time frame: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Region of residence was categorized into following categories: Northeast, North Central, South, West, and other/ missing. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Number of Participants According to Region of Residence: Matched Participants
Time frame: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Region of residence was categorized into following categories: Northeast, North Central, South, West and other/ missing. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Number of Participants According to Payer Type: Unmatched Participants
Time frame: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Payer type was categorized as: commercial and medicare. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Number of Participants According to Payer Type: Matched Participants
Time frame: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Payer type was categorized as: commercial and medicare. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Number of Participants According to Insurance Plan Type: Unmatched Participants
Time frame: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Insurance plan type was categorized into following categories: comprehensive/indemnity, exclusive/preferred provider organization (EPO/PPO), point of service capitation (POS) with or without capitation, health maintenance organization (HMO), consumer driven/ high-deductible health plan (CDHP/HDHP) and missing/unknown. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Number of Participants According to Insurance Plan Type: Matched Participants
Time frame: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Insurance plan type was categorized into following categories: comprehensive/indemnity, EPO/PPO, POS with or without capitation, HMO, CDHP/HDHP and missing/unknown. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Number of Participants According to Industry Type: Unmatched Participants
Time frame: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Industry type was categorized into following categories: finance/insurance/real estate, manufacturing (durable/non-durable goods), retail trade, services, transportation/communications/utilities and other. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Number of Participants According to Industry Type: Matched Participants
Time frame: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Industry type was categorized into following categories: finance/insurance/real estate, manufacturing (durable/non-durable goods), retail trade, services, transportation/communications/utilities and other. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Number of Participants According to Quarter (Q) of Index Year: Unmatched Participants
Time frame: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Quarter of index year was categorized into following categories: Q4 2021, Q1 2022, Q2 2022, Q3 2022 and Q4 2022. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Number of Participants According to Quarter of Index Year: Matched Participants
Time frame: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study
Quarter of index year was categorized into following categories: Q4 2021, Q1 2022, Q2 2022, Q3 2022 and Q4 2022. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Mean Duration of Follow-up: Unmatched Participants
Time frame: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Duration of follow-up was defined as number of months from (and including) the index date to the end of participants variable-length follow-up period. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Mean Duration of Follow-up: Matched Participants
Time frame: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Duration of follow-up was defined as number of months from (and including) the index date to the end of participants variable-length follow-up period. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Mean Elixhauser Comorbidity Index (ECI): Unmatched Participants
Time frame: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
ECI was a measure of comorbidity based on ICD-10 codes. ECI score range was from 0-30. A higher score indicated more comorbidity. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Mean ECI: Matched Participants
Time frame: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
ECI was a measure of comorbidity based on ICD-10 codes. ECI score range was from 0-30. A higher score indicated more comorbidity. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Mean Charlson Comorbidity Index (CCI): Unmatched Participants
Time frame: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
CCI based on various comorbid conditions such as cerebrovascular disease, chronic pulmonary disease, congestive heart failure, dementia, mild/moderate diabetes, diabetes with chronic complications, hemiplegia/paraplegia, human immunodeficiency virus(HIV), mild liver disease, moderate/severe liver disease, malignancy, metastatic solid tumor, myocardial infarction, peptic ulcer disease, peripheral vascular disease, renal disease, rheumatologic disease was reported. CCI score range was from 0 to 33, where "0"= low comorbid condition and "33"= high comorbid condition, higher scores indicated more comorbidity. Index date was the date of first COVID-19 diagnosis. Data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Mean CCI: Matched Participants
Time frame: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
CCI based on various comorbid conditions such as cerebrovascular disease, chronic pulmonary disease, congestive heart failure, dementia, mild/moderate diabetes, diabetes with chronic complications, hemiplegia/paraplegia, HIV, mild liver disease, moderate/severe liver disease, malignancy, metastatic solid tumor, myocardial infarction, peptic ulcer disease, peripheral vascular disease, renal disease, rheumatologic disease was reported. CCI score range was from 0 to 33, where "0"= low comorbid condition and "33"= high comorbid condition, higher scores indicated more comorbidity. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Number of Participants According to Comorbidities: Unmatched Participants
Time frame: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Comorbidities were categorized into following categories: cancer (current or history of), cardio/cerebrovascular disease, chronic kidney disease, chronic liver disease, diabetes mellitus, immunocompromised status, lung disease or tuberculosis, neurodevelopmental disorder/complex condition, overweight/obesity or smoking and pregnancy. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category. Participant can have more than 1 comorbidity.
Number of Participants According to Comorbidities: Matched Participants
Time frame: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Comorbidities were categorized into following categories: cancer (current or history of), cardio/cerebrovascular disease, chronic kidney disease, chronic liver disease, diabetes mellitus, immunocompromised status, lung disease or tuberculosis, neurodevelopmental disorder/complex condition, overweight/obesity or smoking and pregnancy. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category. Participant can have more than 1 comorbidity.
Number of High-risk Conditions Per Participant: Unmatched Participants
Time frame: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
High risk conditions included cancer, cerebrovascular or peripheral vascular disease, chronic lung disease, chronic liver disease, cystic fibrosis, dementia, diabetes, disability, heart conditions, HIV, hypertension, immunocompromised state(primary immunodeficiencies, prolonged use of corticosteroids or other immunosuppressive medications, and other immunocompromised state), mental health conditions(mood disorder or schizophrenia), overweight or obesity, physical inactivity, pregnancy(current or recent), sickle cell disease or thalassemia, smoking (current or former), solid organ or blood stem cell transplant, substance use disorder, tuberculosis. Index date=date of first COVID-19 diagnosis. Data was reported for unmatched participants, they were further sub-grouped on basis of outcome of COVID-19: eligible for absence from work, short term disability, long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Number of High-risk Conditions Per Participant: Matched Participants
Time frame: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
High risk conditions included cancer, cerebrovascular or peripheral vascular disease, chronic lung disease, chronic liver disease, cystic fibrosis, dementia, diabetes, disability, heart conditions, HIV, hypertension, immunocompromised state (primary immunodeficiencies, prolonged use of corticosteroids or other immunosuppressive medications, and other immunocompromised state), mental health conditions (mood disorder or schizophrenia), overweight or obesity, physical inactivity, pregnancy(current or recent), sickle cell disease or thalassemia, smoking (current or former), solid organ or blood stem cell transplant, substance use disorder, tuberculosis. Index date=date of first COVID-19 diagnosis. Data was reported for matched participants, they were further sub-grouped on basis of outcome of COVID-19: eligible for absence from work, short term disability, long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Number of Participants According to COVID-19 Vaccination Status: Unmatched Participant
Time frame: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of participants with >=1 claim for a COVID-19 vaccination during the pre-period was reported in this outcome measure. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Number of Participants According to COVID-19 Vaccination Status: Matched Participant
Time frame: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of participants with >=1 claim for a COVID-19 vaccination during the pre-period was reported in this outcome measure. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Number of Participants With One or More Prior Hospitalization: Unmatched Participants
Time frame: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Prior hospitalization indicated participants who had one or more inpatients visits in the pre-period. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Number of Participants With One or More Prior Hospitalization: Matched Participants
Time frame: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Prior hospitalization indicated participants who had one or more inpatients visits in the pre-period. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Number of Participants With One or More Prior Emergency Room (ER) Visit: Unmatched Participants
Time frame: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Prior ER visit indicates participants who had one or more ER visits in pre-period. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for unmatched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Number of Participants With One or More Prior Emergency Room (ER) Visit: Matched Participants
Time frame: Pre-period (6 months period before index date; during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Prior ER visit indicates participants who had one or more ER visits in pre-period. Index date was the date of first COVID-19 diagnosis. In this outcome measure, data was reported for matched participants, they were further sub-grouped on the basis of outcome of COVID-19: eligible for absence from work, eligible for short term disability and eligible for long term disability. These sub-groups were not mutually exclusive; some participants might be represented in more than one category.
Number of Participants With Presence of Any Absence Records: Matched Participants
Time frame: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of participants with presence of any absence records was reported in this outcome measure. Index date was the date of first COVID-19 diagnosis.
Mean Number of Absence Days Per Participant Per Month (PPPM): Matched Participants
Time frame: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
In this outcome measure mean number of absence days PPPM was reported. Index date was the date of first COVID-19 diagnosis.
Number of Participants According to Type for Absence Claim: Matched Participants
Time frame: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Absence days was reported by absence type: sick, disability and recreational absence. Sick, disability and recreational absence were the leaves which participants took during the study period. Sick absence referred to the time away from work due to an employee's own illness or medical condition, this may be also used for bereavement, caring for a family member with a serious health condition, adoption-related medical needs. Disability absence was recorded when an employee was unable to work due to a short-term or long-term disability. Recreational absence referred to the time off taken for non-medical, personal reasons, such as vacation, personal leave, leisure, or wellness days. Index date was the date of first COVID-19 diagnosis. One participant may have more than one type of absence claim.
Mean Cost of Absence Days: Matched Participants
Time frame: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Estimated sum of wages associated with absence days was calculated as daily wage multiplied by absence days was reported PPPM in this outcome measure. Index date was the date of first COVID-19 diagnosis.
Number of Participants With Any Short Term Disability (STD) Claim: Matched Participants
Time frame: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of participants with presence of any STD claim was reported in this outcome measure. Index date was the date of first COVID-19 diagnosis.
Mean Number of STD Days PPPM: Matched Participants
Time frame: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
In this outcome measure mean number of STD days PPPM was reported. Index date was the date of first COVID-19 diagnosis.
Number of Participants According to Reason for STD Claim: Matched Participants
Time frame: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Reasons for STD were classified as COVID-19 related or non-COVID-19 related or missing/unknown. Index date was the date of first COVID-19 diagnosis.
Mean Cost of STD Days: Matched Participants
Time frame: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Estimated sum of wages associated with absence days STD claim was calculated as 70 percentage (%) of daily wage multiplied by STD days was reported PPPM in this outcome measure. Index date was the date of first COVID-19 diagnosis.
Number of Participants With Any Long Term Disability (LTD) Claim: Matched Participants
Time frame: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Number of participants with presence of any LTD claim was reported in this outcome measure. Index date was the date of first COVID-19 diagnosis.
Mean Number of LTD Days PPPM: Matched Participants
Time frame: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
In this outcome measure mean number of LTD days PPPM was reported. Index date was the date of first COVID-19 diagnosis.
Number of Participants According to Reason for LTD Claim: Matched Participants
Time frame: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Reasons for LTD were classified as COVID-19 related or non-COVID-19 related or missing/unknown. Index date was the date of first COVID-19 diagnosis.
Mean Cost of LTD Days: Matched Participants
Time frame: From index date to the end of follow-up (maximum follow-up was up to an average of 8.3 months during data observation of approximately 1.5 years); retrospective data collected was evaluated in 0.5 months of this study
Estimated sum of wages associated with absence days LTD claim was calculated as 70 percent (%) of daily wage multiplied by LTD days was reported PPPM in this outcome measure. Index date was the date of first COVID-19 diagnosis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 (Coronavirus Disease 2019), run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants According to Age Group: Unmatched Participants (time frame: At index date (any date during index date identification period of approximately 11.5 months); retrospective data collected was evaluated in 0.5 months of this study). The study lists 42 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.