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RECOVERY, 2022 NCT04381936

baricitinib (n=4148) vs. standard of care (n=4008)

randomized controlled trial

baricitinib 4 mg once daily
baricitinib 4 mg once daily by mouth for 10 days or until discharge if sooner

usual standard of care alone

COVID 19 all comers

open-label

COV-BARRIER, 2021 NCT04421027

baricitinib (n=764) vs. placebo (n=761)

randomized controlled trial

Once-daily baricitinib (4 mg) or up to 14 days

Placebo

Standard of care included systemic corticosteroids, such as dexamethasone, and antivirals, including remdesivir.

COVID 19 hospitalized

laboratory-confirmed SARS-CoV-2 infection, had evidence of pneumonia or active and symptomatic COVID-19, and had at least one elevated inflammatory marker (C-reactive protein, D-dimer, lactate dehydrogenase, or ferritin. were excluded if, at study entry, they required invasive mechanical ventilation (National Institute of Allergy and Infectious Disease Ordinal Scale [NIAID-OS] score 7); were receiving immunosuppressants (high-dose corticosteroids, biologics, T-cell-targeted or B-cell-targeted therapies, interferon, or JAK inhibitors); had ever received convalescent plasma or intravenous immunoglobulin for COVID-19; or had neutropenia (absolute neutrophil count <1000 cells per μL), lymphopenia (absolute lymphocyte count <200 cells per μL), alanine aminotransferase (ALT) or aspartate aminotransferase concentration greater than five times the upper limit of normal, or an estimated glomerular filtration rate (eGFR) of less than 30 mL/min per 1·73 m2

Double-blind.

101 centres across 12 countries in Asia, Europe, North America, and South America.

according graphical testing procedure used to test results in a hierarchical manner for controlling the overall family-wise type I error rate (appendix 6 p 14), the twoprimary analyses were at the top of the hierarchy. Population 1 was tested at 99% of the total alpha (0.05) and Population 2 at 1% of 0.05.

because the primary outcome was not statistically significant in the prespecified hierarchical graphical testing procedure, none of the key secondary outcomes could be considered statistically significant using this same procedure.

ACTT-2 (Kalil), 2020 NCT04401579

baricitinib (n=515) vs. placebo (n=518)

randomized controlled trial

baricitinib (≤14 days) and remdesivir (≤10 days)
baricitinib 4-mg daily dose (either orally [two 2-mg tablets] or through a nasogastric tube) for 14 days or until hospital discharge

remdesivir (≤10 days) (and placebo)
remdesivir intravenously as a 200-mg loading dose on day 1, followed by a 100-mg maintenance dose administered daily on days 2 through 10 or until hospital discharge or death

COVID 19 hospitalized

double-blind

67 trial sites in 8 countries

COV-BARRIER (critically ill), 2022 NCT04421027

baricitinib (n=51) vs. placebo (n=50)

randomized controlled trial

Baricitinib
Baricitinib 4mg once daily for up to 14 days, or until discharge from hospital, in combination with standard of care.

Placebo
Matched placebo once daily for up to 14 days in combination with standard of care.

All participants received standard of care in keeping with local clinical practice for COVID-19 management, which could include concomitant medications such as corticosteroids, antivirals, and other treatments, including vasopressors.

COVID-19 severe or critically

Double-blind.

18 hospitals in Argentina, Brazil, Mexico, and the USA.

As the cohort reported here was an addition to the parent trial study design, all endpointsare considered exploratory.

Exploratory trial which followed the study design of COV-BARRIER in a critically ill cohort not included in the main phase 3 trial.