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

a study on COVID-19 Severe Acute Respiratory Syndrome Pneumonia

Summary

Eligibility
for people ages 18-100 (full criteria)
Location
at UC Irvine
Dates
study started
estimated completion

Description

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.

Details

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 without respiratory failure and with certain high risk prognostic factors, as measured by the change in clinical status score.

Keywords

Covid19 SARS (Severe Acute Respiratory Syndrome) SARS Pneumonia SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere Pneumonia Pneumonia, Viral SARS-Associated Coronavirus Pneumonia COVID-19 Coronavirus Infections Severe Acute Respiratory Syndrome Fostamatinib

Eligibility

You can join if…

Open to people ages 18-100

  • ≥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.

You CAN'T join if...

  • 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.

Locations

  • University of California Irvine accepting new patients
    Orange California 92868 United States
  • Providence Portland Medical Center completed
    Portland Oregon 97213 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Rigel Pharmaceuticals
ID
NCT04629703
Phase
Phase 3
Study Type
Interventional
Last Updated