Methodologies for Observational Studies Comparing Inpatient COVID-19 Treatments

Part of paid clinical trials in New York, New York.

Sponsor
Aetion, Inc.
Study ID
NCT05638932
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 16, 2020
Status verified
Sep 2024
Primary completion
Sep 25, 2023
Completion
Sep 25, 2023

Study Design

Enrollment
1,442 participants (actual)

Arms

  • Arm: Interleukin-6 receptor inhibitor (IL6Ri) initiators vs Janus kinase inhibitor (JAKi) initiators
    Hospitalized patients who initiate an IL6Ri versus JAKi in addition to a corticosteroid of interest

Primary Outcome Measure

Inpatient mortality [ Time Frame: up to 28 days after IL6Ri or JAKi initiation ]

Locations (1)

FacilityCityStateZIPSite coordinators
Aetion, Inc.New YorkNew York10001-

Find similar trials in New York, NY

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Aetion, Inc.· New York, NY

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