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Double-Blind, Randomized, Placebo-Controlled, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects

NCT04629703 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2023-08-18

No results posted yet for this study

Summary

The study is a double-blind, randomized, placebo-controlled, multi-center, Phase 3 study to evaluate the efficacy and safety of fostamatinib in COVID-19 subjects.

Conditions

  • Covid19
  • SARS (Severe Acute Respiratory Syndrome)
  • SARS Pneumonia
  • SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
  • Pneumonia
  • Pneumonia, Viral

Interventions

DRUG

Fostamatinib

Fostamatinib (150 mg twice daily) for 14 days and Standard of Care

DRUG

Placebo

Placebo (twice daily) for 14 days and Standard of Care

Sponsors & Collaborators

  • Rigel Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-25
Primary Completion
2022-09-05
Completion
2022-09-05
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Mexico

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT04629703 on ClinicalTrials.gov