MedTrace Logo

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

NCT04362137 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 432

Last updated 2021-10-11

Study results available
· View outcomes & findings →

Summary

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.

Conditions

  • Cytokine Storm (Covid-19)

Interventions

DRUG

Ruxolitinib

Ruxolitinib 5 mg tablets

DRUG

Placebo

Matching-image placebo

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-02
Primary Completion
2020-10-17
Completion
2020-10-17
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Colombia
  • France
  • Germany
  • Mexico
  • Peru
  • Russia
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04362137 on ClinicalTrials.gov