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

Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • ≥18 years of age at screening. - The subject or a legally authorized representative has provided written informed consent. - Hospitalized COVID-19 subjects without respiratory failure who are either not receiving any oxygen therapy or are receiving supplemental oxygen via mask or nasal prongs. - Male or non-pregnant, non-lactating female subjects with SARS-CoV-2 infection documented by a hospital approved diagnostic test (eg, a Food and Drug Administration authorized test in the US) within 7 days prior to randomization.

Exclusion Criteria

  • Pregnant or lactating female of childbearing potential. - Use of extracorporeal membrane oxygenation (ECMO). - Uncontrolled hypertension (systolic blood pressure [BP] ≥160 mmHg and/or diastolic BP ≥100 mmHg), unstable angina, congestive heart failure of New York Heart Association classification III or IV, serious cardiac arrhythmia requiring treatment at screening. - History of myocardial infarction within 1 month prior to screening.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Fostamatinib (150 mg twice daily for 14 days) + Standard of Care 		Fostamatinib (150 mg twice daily for 14 days) + Standard of Care
  • Drug: Fostamatinib
    Fostamatinib (150 mg twice daily) for 14 days and Standard of Care
    Other names:
    • Fostamatinib disodium
Placebo Comparator
Placebo (twice daily for 14 days) + Standard of Care 		Placebo (twice daily for 14 days) + Standard of Care
  • Drug: Placebo
    Placebo (twice daily) for 14 days and Standard of Care

Recruiting Locations

More Details

NCT ID
NCT04629703
Status
Completed
Sponsor
Rigel Pharmaceuticals

Detailed Description

The primary objective of this study is: To evaluate the efficacy of fostamatinib when used in combination with standard of care (SOC) in subjects hospitalized with COVID- 19 and requiring oxygen supplementation, as measured by days on oxygen.