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NCT05638932 · ClinicalTrials.gov registry record
Methodologies for Observational Studies Comparing Inpatient COVID-19 Treatments
A clinical trial of COVID-19, sponsored by Aetion.
- Completed
- Registry status
- 1,442
- Enrollment target
- 1
- Study location
NCT05638932 is a study of COVID-19 that has completed, run by Aetion. The registered enrollment target is 1,442 participants, below the 55,207-participant average among 203 other COVID-19 trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05638932, a study of COVID-19, has completed, sponsored by Aetion.
- COMPLETED
- Registry status
- 1,442 participants
- Enrollment target
- 1
- Study location
Study Summary
To apply and compare two different methodological approaches (one applying diagnostics steps and contingencies and the other not) to the illustrative example described below: Illustrative Example - Objective I aims to characterize the risk of inpatient mortality \[Primary Outcome\] and progression to invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) \[Secondary Outcome\] up to 28 days after interleukin-6 receptor inhibitors (IL6Ri) or janus kinase inhibitor (JAKi) initiation among patients hospitalized with Coronavirus Disease 2019 (COVID-19) who initiate a corticosteroid of interest and require supplemental oxygen / non-invasive ventilation / high flow oxygen (O2/NIV/HFO) (but not IMV/ECMO). Illustrative Example - Objective II aims to characterize the risk of inpatient mortality \[Primary Outcome\] up to 28 days after IL6Ri or JAKi initiation among patients admitted to the ICU at hospital admission with COVID-19 who initiate a CSI and require IMV/ECMO. Hazard ratios (HR) and corresponding 95% confidence intervals (CI) will be estimated and reported for all outcome risks in Illustrative Example objectives.
Conditions Studied
Interventions
- DRUG Initiation of IL6Ri (tocilizumab or sarilumab) versus JAKi (baricitinib or tofacitinib) added to systemic corticosteroids of interest (CSI)
Study Locations (1)
New York
- Aetion, Inc. - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,442 participants |
| Start Date | 2020-06-16 |
| Est. Completion | 2023-09-25 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05638932
The ClinicalTrials.gov registry entry for NCT05638932 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 1,442 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55,207-participant average among 203 other COVID-19 trials with a reported enrollment target (97% lower). The listed sponsor is Aetion, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 1 intervention - of which Initiation of IL6Ri (tocilizumab or sarilumab) versus JAKi (baricitinib or tofacitinib) added to systemic corticosteroids of interest (CSI) is the first listed.
NCT05638932 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT05638932 about?
NCT05638932 is a clinical study titled "Methodologies for Observational Studies Comparing Inpatient COVID-19 Treatments". To apply and compare two different methodological approaches (one applying diagnostics steps and contingencies and the other not) to the illustrative example described below: Illustrative Example - Objective I aims to characterize the risk of inpatient mortality \[Primary Outcome\] and progression ...
What is the current status of trial NCT05638932?
This trial is currently completed. The enrollment target is 1,442 participants. The study started on 2020-06-16. Estimated completion is 2023-09-25.
What conditions does trial NCT05638932 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT05638932?
The interventions under investigation include: Initiation of IL6Ri (tocilizumab or sarilumab) versus JAKi (baricitinib or tofacitinib) added to systemic corticosteroids of interest (CSI) (DRUG).
Who is sponsoring clinical trial NCT05638932?
This trial is sponsored by Aetion, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05638932 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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