Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm

Conditions

• Cytokine Storm (Covid-19)

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ruxolitinib — DRUG
  Ruxolitinib 5 mg tablets
• Placebo — DRUG
  Matching-image placebo

Study Details

This was a randomized, double-blind, placebo-controlled, 29-day, multicenter study to assess the efficacy and safety of ruxolitinib + standard-of-care (SoC) therapy, compared with placebo + SoC therapy, in patients aged ≥12 years with COVID-19 disease.

Key Dates

Start date

May 2, 2020

Status verified

Oct 2021

Primary completion

Oct 17, 2020

Completion

Oct 17, 2020

Study Design

Enrollment

432 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ruxolitinib 5 mg
  Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
• Placebo Comparator: Placebo
  Matching-image placebo for 14 days with possible extension of treatment to 28 days

Primary Outcome Measure

Proportion of Patients Who Die, Develop Respiratory Failure [Require Mechanical Ventilation] or Require Intensive Care Unit (ICU) Care [ Time Frame: Day 1 - Day 29 ]

Locations (11)

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