Randomized Phase 3 Trial of Ruxolitinib for COVID-19–Associated Acute Respiratory Distress Syndrome*
OBJECTIVES:
Evaluate the safety and efficacy of the Janus kinase (JAK)1/JAK2 inhibitor ruxolitinib in COVID-19–associated acute respiratory distress syndrome requiring mechanical ventilation.
DESIGN:
Phase 3 randomized, double-blind, placebo-controlled trial Ruxolitinib in Participants With COVID-19–Associated Acute Respiratory Distress Syndrome Who Require Mechanical Ventilation (RUXCOVID-DEVENT; NCT04377620).
SETTING:
Hospitals and community-based private or group practices in the United States (29 sites) and Russia (4 sites).
PATIENTS:
Eligible patients were greater than or equal to 12 years old, hospitalized with severe acute respiratory syndrome coronavirus 2 infection, and mechanically ventilated with a Pao2/Fio2 of less than or equal to 300 mm Hg within 6 hours of randomization.
INTERVENTIONS:
Patients were randomized 2:2:1 to receive twice-daily ruxolitinib 15 mg, ruxolitinib 5 mg, or placebo, each plus standard therapy.
MEASUREMENTS AND MAIN RESULTS:
The primary endpoint, 28-day mortality, was tested for each ruxolitinib group versus placebo using a mixed-effects logistic regression model and one-tailed significance test (significance threshold: p
Source: Critical Care Medicine - Category: Emergency Medicine Tags: Feature Articles Source Type: research
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