CoronavirusNCT04926571
Dexamethasone and COVID-19 Inpatient Mortality
An observational study of Coronavirus, run by Aetion, Inc. at 1 site in United States.
Trial summary
The study aims to assess the effectiveness of dexamethasone initiation to reduce the risk of inpatient mortality within 28 days among US patients hospitalized with COVID-19 diagnosis or SARS-CoV-2 infection, overall and stratified by COVID-19 severity subgroups. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronavirus
- What is being tested?
- Dexamethasone Oral
- Type of treatment
- Pill or oral medicine
- How many people
- 14,105 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2020to 27 Aug 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospitalized Patients with confirmed COVID-19 (diagnosis of U07.1 or positive or presumptive positive SARS-CoV-2 diagnostic laboratory test result) occurring between 21 days prior to the hospital admission date and the treatment index date. Patients will enter the cohort upon the admission date of the first qualifying inpatient hospitalization observed in the hospital chargemaster data. The first eligible cohort entry date is 01-April-2020, the date when the ICD-10 code for COVID-19 diagnosis was added.
Who may be able to join
- Hospitalized Patients with confirmed COVID-19 (diagnosis of U07.1 or positive or presumptive positive SARS-CoV-2 diagnostic laboratory test result) occurring between 21 days prior to the hospital admission date and the treatment index date.
Who cannot join
- No interaction with the healthcare system (medical encounter) in the 183 days prior to and including hospital admission (Day -183 to Day 0) to minimize the potential for misclassification of baseline covariates and/or new use
- No age or sex recorded in the 183 days prior to and including hospital admission (Day -183 to Day 0) as required for matching
- No geographic region recorded in 183 days prior to and including hospital admission (Day -183 to Day 0) as necessary to adjust for regional variation
- Any recorded use of any CSI (dispensing or remaining supply) in the 90-day washout prior to the treatment index date (Day T-90 to Day T-1) to satisfy new use definition
- Any record of a COVID-19 vaccine recorded on or any time prior to the treatment index date given that these patients are assumed to be selectively different (Day S to Day T)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dexamethasone on Inpatient Mortality Among Hospitalized COVID-19 Patients
The study aims to assess the effectiveness of dexamethasone initiation to reduce the risk of inpatient mortality within 28 days among US patients hospitalized with COVID-19 diagnosis or SARS-CoV-2 infection, overall and stratified by COVID-19 severity subgroups.
Read the detailed description
This is a non-randomized, non-interventional study that is part of a research collaboration agreement between the US Food and Drug Administration (FDA) and Aetion to use real-world data to advance the understanding and the natural history of COVID-19 in specific patient populations, as well as treatment and diagnostic patterns during the coronavirus disease (COVID-19) pandemic.
This study compares inpatient mortality within 28 days among US patients hospitalized with COVID-19 diagnosis or SARS-CoV-2 infection who initiate dexamethasone treatment with a matched cohort of patients with 'standard of care' who are non-users of corticosteroids of interest (dexamethasone, prednisone, methylprednisolone, hydrocortisone). Patients are compared overall and and stratified by COVID-19 severity subgroups.
- Conditions
- Coronavirus
- Being tested
- Dexamethasone Oral
- Keywords
- treatment, dexamethasone, corticosteroid, mortality
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone OralDrug
New users of Dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone versus non-users of corticosteroids | Not described Receives: Drug: Dexamethasone Oral | |
| Dexamethasone versus non-users of dexamethasone | Not described Receives: Drug: Dexamethasone Oral | |
| Dexamethasone versus methylprednisolone active comparator | Not described Receives: Drug: Dexamethasone Oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality within 28 days of admission
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start1 Apr 2020
- Primary completion27 Aug 2021
- Study completion27 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 14,105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aetion, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolle Gatto, Aetion, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926571
- Sponsor's protocol ID
- RQ004-1-20210610
- Status last verified
- Apr 2023
- First submitted
- 11 Jun 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Study results will report aggregated findings
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexamethasone on Inpatient Mortality Among Hospitalized COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04926571
- Acronym / sponsor ID
- RQ004-1-20210610
- Conditions
- Coronavirus
- Keywords
- treatment, dexamethasone, corticosteroid, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14,105 participants (actual)
- Lead sponsor
- Aetion, Inc.University, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 27 Aug 2021 (actual)
- Study completion
- 27 Aug 2021 (actual)
- First posted
- 15 Jun 2021 (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 study aims to assess the effectiveness of dexamethasone initiation to reduce the risk of inpatient mortality within 28 days among US patients hospitalized with COVID-19 diagnosis or SARS-CoV-2 infection, overall and stratified by COVID-19 severity subgroups.
Detailed description
This is a non-randomized, non-interventional study that is part of a research collaboration agreement between the US Food and Drug Administration (FDA) and Aetion to use real-world data to advance the understanding and the natural history of COVID-19 in specific patient populations, as well as treatment and diagnostic patterns during the coronavirus disease (COVID-19) pandemic.
This study compares inpatient mortality within 28 days among US patients hospitalized with COVID-19 diagnosis or SARS-CoV-2 infection who initiate dexamethasone treatment with a matched cohort of patients with 'standard of care' who are non-users of corticosteroids of interest (dexamethasone, prednisone, methylprednisolone, hydrocortisone). Patients are compared overall and and stratified by COVID-19 severity subgroups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone versus non-users of corticosteroids | – | Drug: Dexamethasone Oral |
| Dexamethasone versus non-users of dexamethasone | – | Drug: Dexamethasone Oral |
| Dexamethasone versus methylprednisolone active comparator | – | Drug: Dexamethasone Oral |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitalized Patients with confirmed COVID-19 (diagnosis of U07.1 or positive or presumptive positive SARS-CoV-2 diagnostic laboratory test result) occurring between 21 days prior to the hospital admission date and the treatment index date. Patients will enter the cohort upon the admission date of the first qualifying inpatient hospitalization observed in the hospital chargemaster data. The first eligible cohort entry date is 01-April-2020, the date when the ICD-10 code for COVID-19 diagnosis was added.
Key inclusion criteria (1 listed)
- Hospitalized Patients with confirmed COVID-19 (diagnosis of U07.1 or positive or presumptive positive SARS-CoV-2 diagnostic laboratory test result) occurring between 21 days prior to the hospital admission date and the treatment index date.
Key exclusion criteria (5 listed)
- No interaction with the healthcare system (medical encounter) in the 183 days prior to and including hospital admission (Day -183 to Day 0) to minimize the potential for misclassification of baseline covariates and/or new use
- No age or sex recorded in the 183 days prior to and including hospital admission (Day -183 to Day 0) as required for matching
- No geographic region recorded in 183 days prior to and including hospital admission (Day -183 to Day 0) as necessary to adjust for regional variation
- Any recorded use of any CSI (dispensing or remaining supply) in the 90-day washout prior to the treatment index date (Day T-90 to Day T-1) to satisfy new use definition
- Any record of a COVID-19 vaccine recorded on or any time prior to the treatment index date given that these patients are assumed to be selectively different (Day S to Day T)
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 |
|---|---|---|
| Dexamethasone OralNew users of Dexamethasone | Drug | Dexamethasone versus methylprednisolone active comparator, Dexamethasone versus non-users of corticosteroids, Dexamethasone versus non-users of dexamethasone |
Primary outcome
Mortality
Time frame: 28 days
Mortality within 28 days of admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No. Study results will report aggregated findings
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Coronavirus, run by Aetion, Inc. 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 1 inclusion and 5 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 18 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mortality (time frame: 28 days). 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 18 Apr 2023.