Safety and Efficacy of Ruxolitinib for COVID-19

Sponsor
University of Colorado, Denver
Study ID
NCT04348071
Phase
PHASE2/PHASE3
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    Participants will receive 10 mg ruxolitinib twice daily.

Study Details

This study plans to learn more about the effects of a medicine called ruxolitinib on the progression of COVID-19 (coronavirus disease of 2019), the medical condition caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Ruxolitinib is FDA-approved for the treatment of myelofibrosis, polycythemia vera, and graft-versus-host disease. This study intends to define the impact of ruxolitinib on the severity and progression of COVID-19. This drug might to lower the hyperinflammation caused by the virus, which would prevent damage to the lungs and possibly other organs. The study will recruit patients who have been diagnosed with COVID-19. The goal is to recruit 80 patients.

Key Dates

Start date
Jul 31, 2021
Status verified
Mar 2021
Primary completion
Aug 31, 2021
Completion
Oct 31, 2021

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib
    This study is an Adaptive Phase 2/3 trial designed to test the safety (Phase 2) and efficacy (Phase 2 and 3) of ruxolitinib to treat COVID-19. Phase 2 consists of a single-arm, open-label assignment of 20 participants receiving 10 mg ruxolitinib twice daily for 14 days. Phase 3 consists of a single-arm, open-label assignment of 60 additional participants receiving ruxolitinib at the same dose. In both phases, participants will be monitored daily while hospitalized for 29 days, or until discharge, whichever occurs first. Participants who are discharged will be followed up with via phone on Day 15 and Day 29.

Primary Outcome Measure

Phase 2: Cumulative incidence of Grade 3 and 4 adverse events (AEs) [ Time Frame: Day 0 (screening) through Day 29 ]

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