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

Part of paid clinical trials in Orange, California.

Sponsor
Rigel Pharmaceuticals
Study ID
NCT04629703
Phase
PHASE3
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Fostamatinib — DRUG
    Fostamatinib (150 mg twice daily) for 14 days and Standard of Care
  • Placebo — DRUG
    Placebo (twice daily) for 14 days and Standard of Care

Study Details

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.

Key Dates

Start date
Mar 25, 2021
Status verified
Aug 2023
Primary completion
Sep 5, 2022
Completion
Sep 5, 2022

Study Design

Enrollment
280 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Fostamatinib (150 mg twice daily for 14 days) + Standard of Care
    Fostamatinib (150 mg twice daily for 14 days) + Standard of Care
  • Placebo Comparator: Placebo (twice daily for 14 days) + Standard of Care
    Placebo (twice daily for 14 days) + Standard of Care

Primary Outcome Measure

Number of days on oxygen from randomization on Day 1 to Day 29 [ Time Frame: 29 days ]

Locations (9)

FacilityCityStateZIPSite coordinators
University of California IrvineOrangeCalifornia92868-
George Washington University HospitalWashington D.C.District of Columbia20037-
Alternative Research Associates, LLCHialeahFlorida33012-
Alternative Research Associates, LLCMiamiFlorida33143-
Loyola University Medical SchoolMaywoodIllinois60600-
Harvard Medical School- Bringham and Women's HospitalBostonMassachusetts02115-
Henry FordDetroitMichigan48202-
Ascension Medical Group- St. John Clinic Infectious DiseaseTulsaOklahoma74101-
Houston Methodist Research InstituteHoustonTexas77030-

Find similar trials in Orange, CA

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
University of California Irvine· Orange, CAGeorge Washington University Hospital· Washington D.C., DCAlternative Research Associates, LLC· Hialeah, FLAlternative Research Associates, LLC· Miami, FLLoyola University Medical School· Maywood, ILHarvard Medical School- Bringham and Women's Hospital· Boston, MA

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