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Methodologies for Observational Studies Comparing Inpatient COVID-19 Treatments

NCT05638932 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1442

Last updated 2024-09-19

No results posted yet for this 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

Interventions

DRUG

Initiation of IL6Ri (tocilizumab or sarilumab) versus JAKi (baricitinib or tofacitinib) added to systemic corticosteroids of interest (CSI)

Real world use of either IL6Ri (TCZ or SAR) or JAKi (BAR or TOF)

Sponsors & Collaborators

  • Aetion, Inc.

    lead OTHER

Principal Investigators

  • Vera Frajzyngier, PhD · Aetion, Inc.

  • Liz M Garry, PhD · Aetion, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-16
Primary Completion
2023-09-25
Completion
2023-09-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05638932 on ClinicalTrials.gov