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Baricitinib in COVID-19 Pneumonia
NCT04399798Phase 2
Key facts
- Status
- Unknown
- Start
- May 2020
- Primary completion
- Sep 2020
- Sponsor
- IRCCS San Matteo Foundation
- Modality
- Recombinant Proteins and Enzymes, Small Molecules, Antibody-Based Therapeutics
- Drugs
- baricitinib
- Conditions
- COVID-19 pneumonia
01
Overview
Phase 2, open-label, single-arm trial of baricitinib in COVID-19 pneumonia, sponsored by IRCCS San Matteo Foundation. Primary endpoints: Response to treatment: absence of moderate to severe oxygenation impairment or death at 8 days and Response to treatment: survival at 8 days. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Baricitinib active treatment
Baricitinib 4 mg/day
03
Who it enrols
Adult patients (18-74) with confirmed SARS-CoV-2 pneumonia, infiltrates, and inflammatory markers, excluding those requiring mechanical ventilation or with severe renal/hepatic impairment.
04
Endpoints
Primary
Response to treatment: absence of moderate to severe oxygenation impairment or death
Response to treatment: survival
Secondary
Rate of moderate or severe oxygenation impairment
Mortality
Peripheral capillary oxygen saturation
Partial pressure of oxygen/fraction inspired oxygen
Rate of patients admitted to the intensive care unit
Length of hospital stay
Rate of re-admission
Cumulative incidence and severity of adverse events
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