COVID-19NCT06163677
A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza.
An observational study of COVID-19 and Coronavirus Disease 2019, run by Pfizer.
Trial summary
The main purpose of this study is to understand: the symptoms of COVID-19 or influenza health-related outcomes of people with COVID-19 or influenza the effects of vaccines in people with COVID-19 or influenza. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Coronavirus Disease 2019, Influenza
- What is being tested?
- COVID-19 Vaccine
- Type of treatment
- Vaccines
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 17 Jan 2024to 17 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Participants 18 years or older who are self-reported symptomatic, with laboratory-confirmed illness when tested at any of Walgreens pharmacy COVID-19 or influenza test sites, and consent to participate in the study.
Who may be able to join
- Age 18 or older
- Self-reported at least one symptom in the screening questionnaire
- Positive result reported from the laboratory
- Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
- Able to complete the questionnaires by themselves in English
Who cannot join
- Positive result for both COVID-19 and influenza (coinfection)
- COVID-19 test is done with non-RT-PCR methods such as a rapid antigen test or antibody test
About this study
Official title: Patient-Reported Outcomes Associated With COVID-19 and Influenza: A Prospective Survey Study on Outpatient Symptomatic Adults With Laboratory-Confirmed Illness in the United States
The main purpose of this study is to understand:
- the symptoms of COVID-19 or influenza
- health-related outcomes of people with COVID-19 or influenza
- the effects of vaccines in people with COVID-19 or influenza.
This study will take in participants who are:
- 18 years or older
- reported to have symptoms with lab tests that have confirmed illness. The lab tests can be tested at any of Walgreens pharmacy COVID-19 or influenza test sites.
The study will collect vaccine history information from participants who are ready to take part in the study. Participant will be emailed a form with questions about their health related to COVID-19 or influenza during twelve follow-ups over a 6-month period.
Read the detailed description
This is a prospective non-interventional longitudinal cohort survey study. Repeated measures on PROs: symptoms (prevalence, frequency, duration, and severity), EQ-5D-5L, WPAI and PROMIS-Fatigue short form 8a over 6 months will be collected and evaluated.
COVID-19 Cohort: Participants 18 years or older with laboratory-confirmed COVID-19 illness and at least one patient-reported symptom.
Influenza Cohort: Participants 18 years or older with laboratory-confirmed influenza illness and at least one patient-reported symptom.
All study objectives and outcomes will be assessed separately for the two study cohorts.
- Conditions
- COVID-19, Coronavirus Disease 2019, Influenza
- Being tested
- COVID-19 Vaccine
- Keywords
- Patient-Reported Outcomes, Humanistic Burden, Quality of Life, Disease Symptoms Assessment, COVID-19, SARS-CoV-2, Severe Acute Respiratory Syndrome Coronavirus 2 Infection, Acute respiratory infection, Influenza, Human Influenza
- Medical subject headings
- COVID-19, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 VaccineBiological
Receipt of Pfizer BioNTech COVID-19 vaccine
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Positive | Laboratory-confirmed COVID-19 illness and at least one patient-reported symptom Receives: Biological: COVID-19 Vaccine | |
| Influenza Positive | Laboratory-confirmed influenza illness and at least one patient-reported symptom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence, Severity, and duration of SARS-CoV-2 symptoms
To characterize prevalence and duration of SARS-CoV-2 symptoms before COVID-19 and up to 6 months (acute phase and Long COVID).
Measured: 6 Months
Prevalence, Severity, and duration of influenza symptoms
To characterize prevalence and duration of influenza symptoms before influenza and up to 6 months (acute phase and Long Flu).
Measured: 6 Months
Change in Health Related Quality of Life (HRQoL) using EQ-5D-5L
To assess the change in HRQoL using EQ-5D-5L before COVID-19 or influenza and over a 6-month period following lab confirmed COVID-19 or influenza.
Measured: 6 Months
Change in Health Related Quality of Life (HRQoL) using WPAI:GH
To assess the change in HRQoL using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) before COVID-19 or influenza and over a 6-month period following lab confirmed COVID-19 or influenza.
Measured: 6 Months
EQ-5D-5L Utility Index (UI) scores
To estimate the EQ-5D-5L UI scores and their change over six months following lab confirmed COVID-19 or influenza.
Measured: 6 Months
Visual Analog Scale (VAS) scores
To estimate the VAS scores and their change over six months following the lab confirmed COVID-19 or influenza.
Measured: 6 Months
Work Productivity and Activity Impairment (WPAI) scores
To estimate the WPAI scores and their change over six months following the lab confirmed COVID-19 or influenza.
Measured: 6 Months
Secondary outcomes (1)
Fatigue after COVID-19 or influenza
To estimate the PROMIS questionnaire Fatigue short-form 8a score and its change over six months following lab confirmed COVID-19 or influenza.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start17 Jan 2024
- Primary completion17 Jan 2024
- Study completion17 Jan 2024
Why it stopped: Study cancelled due to change in feasibility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 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
- NCT06163677
- Sponsor's protocol ID
- C4591064
- Status last verified
- Feb 2024
- First submitted
- 7 Dec 2023
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Outcomes Associated With COVID-19 and Influenza: A Prospective Survey Study on Outpatient Symptomatic Adults With Laboratory-Confirmed Illness in the United States
- ClinicalTrials.gov ID
- NCT06163677
- Acronym / sponsor ID
- C4591064
- Conditions
- COVID-19, Coronavirus Disease 2019, Influenza
- Keywords
- Patient-Reported Outcomes, Humanistic Burden, Quality of Life, Disease Symptoms Assessment, COVID-19, SARS-CoV-2, Severe Acute Respiratory Syndrome Coronavirus 2 Infection, Acute respiratory infection
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study cancelled due to change in feasibility.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 17 Jan 2024 (actual)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to understand:
- the symptoms of COVID-19 or influenza
- health-related outcomes of people with COVID-19 or influenza
- the effects of vaccines in people with COVID-19 or influenza.
This study will take in participants who are:
- 18 years or older
- reported to have symptoms with lab tests that have confirmed illness. The lab tests can be tested at any of Walgreens pharmacy COVID-19 or influenza test sites.
The study will collect vaccine history information from participants who are ready to take part in the study. Participant will be emailed a form with questions about their health related to COVID-19 or influenza during twelve follow-ups over a 6-month period.
Detailed description
This is a prospective non-interventional longitudinal cohort survey study. Repeated measures on PROs: symptoms (prevalence, frequency, duration, and severity), EQ-5D-5L, WPAI and PROMIS-Fatigue short form 8a over 6 months will be collected and evaluated.
COVID-19 Cohort: Participants 18 years or older with laboratory-confirmed COVID-19 illness and at least one patient-reported symptom.
Influenza Cohort: Participants 18 years or older with laboratory-confirmed influenza illness and at least one patient-reported symptom.
All study objectives and outcomes will be assessed separately for the two study cohorts.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Positive | – | Biological: COVID-19 VaccineLaboratory-confirmed COVID-19 illness and at least one patient-reported symptom |
| Influenza Positive | – | –Laboratory-confirmed influenza illness and at least one patient-reported symptom |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants 18 years or older who are self-reported symptomatic, with laboratory-confirmed illness when tested at any of Walgreens pharmacy COVID-19 or influenza test sites, and consent to participate in the study.
Key inclusion criteria (5 listed)
- Age 18 or older
- Self-reported at least one symptom in the screening questionnaire
- Positive result reported from the laboratory
- Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
- Able to complete the questionnaires by themselves in English
Key exclusion criteria (2 listed)
- Positive result for both COVID-19 and influenza (coinfection)
- COVID-19 test is done with non-RT-PCR methods such as a rapid antigen test or antibody test
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 |
|---|---|---|
| COVID-19 VaccineReceipt of Pfizer BioNTech COVID-19 vaccine | Biological | COVID-19 Positive |
Primary outcome
Prevalence, Severity, and duration of SARS-CoV-2 symptoms
Time frame: 6 Months
To characterize prevalence and duration of SARS-CoV-2 symptoms before COVID-19 and up to 6 months (acute phase and Long COVID).
Prevalence, Severity, and duration of influenza symptoms
Time frame: 6 Months
To characterize prevalence and duration of influenza symptoms before influenza and up to 6 months (acute phase and Long Flu).
Change in Health Related Quality of Life (HRQoL) using EQ-5D-5L
Time frame: 6 Months
To assess the change in HRQoL using EQ-5D-5L before COVID-19 or influenza and over a 6-month period following lab confirmed COVID-19 or influenza.
Change in Health Related Quality of Life (HRQoL) using WPAI:GH
Time frame: 6 Months
To assess the change in HRQoL using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) before COVID-19 or influenza and over a 6-month period following lab confirmed COVID-19 or influenza.
EQ-5D-5L Utility Index (UI) scores
Time frame: 6 Months
To estimate the EQ-5D-5L UI scores and their change over six months following lab confirmed COVID-19 or influenza.
Visual Analog Scale (VAS) scores
Time frame: 6 Months
To estimate the VAS scores and their change over six months following the lab confirmed COVID-19 or influenza.
Work Productivity and Activity Impairment (WPAI) scores
Time frame: 6 Months
To estimate the WPAI scores and their change over six months following the lab confirmed COVID-19 or influenza.
1 secondary outcome
Fatigue after COVID-19 or influenza
Time frame: 6 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- 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.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Coronavirus Disease 2019, run by Pfizer.
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 2 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: withdrawn, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Prevalence, Severity, and duration of SARS-CoV-2 symptoms (time frame: 6 Months). The study lists 7 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 1 Mar 2024.