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

Completed · Phase 3 · Has a placebo group

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

In brief

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 facts

Study ID

NCT04629703

Run by

Rigel Pharmaceuticals

People needed

280

Starts

2021-03-25

Expected to finish

2022-09-05

Last updated by the study team

2023-08-18

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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 may not qualify 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.

Where it is running

• University of California Irvine — Orange, California, United States
• George Washington University Hospital — Washington D.C., District of Columbia, United States
• Alternative Research Associates, LLC — Hialeah, Florida, United States
• Alternative Research Associates, LLC — Miami, Florida, United States
• Loyola University Medical School — Maywood, Illinois, United States
• Harvard Medical School- Bringham and Women's Hospital — Boston, Massachusetts, United States
• Henry Ford — Detroit, Michigan, United States
• Ascension Medical Group- St. John Clinic Infectious Disease — Tulsa, Oklahoma, United States
• Houston Methodist Research Institute — Houston, Texas, United States
• Corporacion Medica de General San Martin — San Martín, Buenos Aires, Argentina
• Clinica Chutro — Córdoba, CP, Argentina
• Hospital Lencinas — Godoy Cruz, Mendoza Province, Argentina
• Hospital de Alta Complejidad Cuenta Alta — Buenos Aires, Argentina
• Hospital Del Bicentenario - Dr. Luis Federico Leloir — Buenos Aires, Argentina
• Clinica Zabala — Buenos Aires, Argentina
• Clinica Adventista Belgrano — Buenos Aires, Argentina
• Clinica Monte Grande — Buenos Aires, Argentina
• Hospital de Infecciosas Dr.Francisco Javier Muñiz — Buenos Aires, Argentina
• Sanatorio Guemes — Buenos Aires, Argentina
• Sanatorio Sagrado Corazon — Buenos Aires, Argentina
• Hospital San Roque — Córdoba, Argentina
• Sanatorio Mayo Privado — Córdoba, Argentina
• Hospital das Clínicas da Universidade Federal de Goiás (HC/UFG) — Goiânia, Goiás, Brazil
• Hospital Luxenburgo-Associação Mário Penna — Belo Horizonte, Minas Gerais, Brazil
• Hosp. Angelina Caron — Campina Grande do Sul, Paraná, Brazil

Full record on ClinicalTrials.gov

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