COVID-19 Clinical Trial
Official title:
Methodologies for Observational Studies Comparing Inpatient COVID-19 Treatments: IL-6 Receptor Inhibitors and JAK Inhibitors for Hospitalized COVID-19 Patients Receiving Corticosteroid Therapy
Verified date | September 2023 |
Source | Aetion, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 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.
Status | Active, not recruiting |
Enrollment | 3000 |
Est. completion date | September 2023 |
Est. primary completion date | September 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Hospitalized from June 16, 2020 to February 01, 2022 with an ICD-10 diagnosis code of U07.1 in an any admitting diagnosis position (Day 0) - Initiate either IL6Ri or JAKi within 4 days after hospital admission (Days 0 to 4) - Receiving systemic CSI on day of IL6Ri/JAKi initiation (Day T) - Receipt of at least one respiratory support procedure (oxygen supplementation at a minimum) from admission to IL6Ri/JAKi initiation (Days 0 to T) For Illustrative Example - Objective I only: -maximum mWHO disease severity of O2/NIV/HFO from admission to IL6Ri/JAKi initiation (Days 0 to T) For Illustrative Example - Objective II only: - Admission to ICU at hospital admission (Day 0) and mWHO disease severity of IMV/ECMO from hospital/ICU admission to IL6Ri/JAKi initiation (Days 0 to T) - Continuous medical claims enrollment (60-day gaps permitted) during the 183 day baseline period prior to and including hospital or ICU admission (Days -183 to 0) to minimize the potential for misclassification of baseline covariates Exclusion Criteria: - Exclude patients without continuous medical claims enrollment (60-day gaps permitted) during the 183-day baseline period prior to and including hospital/ICU admission (Days -183 to 0) to minimize the potential for misclassification of baseline covariates. - Exclude patients if COVID-19 hospitalization (Day 0) begins >14 days after initial COVID-19 diagnosis. Patients will be excluded if any COVID-19 diagnosis is recorded from 90 days to 15 days before admission (Days -90 to -15) to exclude patients with possible long-term COVID or post-acute sequelae while still permitting prior infections recorded more than 90 days pre-admission. - No age, sex, or geographic region recorded on hospital admission (Day 0) - Age less than 18 years at hospital admission (Day 0) - Evidence of a prior COVID-related inpatient hospitalization in the previous 14 days (Days -14 to -3), with a two-day buffer to permit brief inpatient utilization directly proceeding transfer to a chargemaster hospital (i.e., inpatient utilization permitted on Days -2 to -1) - Systemic CSI use (dispensing or remaining supply) in the previous 14 days (Days -14 to -3), with a two-day buffer to permit CSI use beginning in the emergency department or other healthcare setting immediately prior to chargemaster hospital admission (CSI use permitted Days -2 to -1) - Any recorded use of IL6Ri or JAKi (dispensing or remaining supply) in the 90-day washout period before IL6Ri or JAKi initiation (Days -90 to T-1), to satisfy new use definition - Baseline receipt of oxygen or ventilation support for non-COVID conditions (e.g., supplemental oxygen for COPD), defined as two or more respiratory support procedures recorded on different days from Days -90 to -15 via procedure codes from medical claims, chargemaster, and where available, oxygen supplies recorded in pharmacy settings. - Death or discharge occurs before or on the day of treatment initiation (Days 0 to T) - Recorded use of both IL6Ri and JAKi on Day T |
Country | Name | City | State |
---|---|---|---|
United States | Aetion, Inc. | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Aetion, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Inpatient mortality | Inpatient mortality up to 28 days after IL6Ri or JAKi initiation | up to 28 days after IL6Ri or JAKi initiation | |
Secondary | Progression to IMV or ECMO | Progression to IMV or ECMO up to 28 days after IL6Ri or JAKi initiation (Illustrative Example - Objective I only) | up to 28 days after IL6Ri or JAKi initiation |
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