Methodologies for Observational Studies Comparing Inpatient COVID-19 Treatments

Launched by AETION, INC. · Dec 2, 2022

Keywords

ClinConnect Summary

In this study we seek to evaluate current methodologies for observational comparative studies of inpatient COVID-19 treatments \[Overall Study Objective\]. To support this overall study objective, we have defined additional supporting objectives related to the research process \[Process Objectives\] as applied to an illustrative example of an observational study to evaluate the comparative effectiveness of inpatient COVID-19 treatments \[Illustrative Example\].

Process Objectives:

Characterize differences in study results when an intentional multiphase approach (IMA) to diagnostics and co...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Hospitalized from June 16, 2020 to February 01, 2022 with an international classification of diseases (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 modified World Health Organization (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

Trial Officials