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

Last updated: December 10, 2021
Sponsor: Rigel Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Influenza

Viral Infections

Respiratory Failure

Treatment

N/A

Clinical Study ID

TX289042
C-935788-061
  • Ages 18-100
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 (e. g., a Food and Drug Administration authorized test in the US) within 7 days prior to randomization.

Exclusion

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

Study Start date:
Estimated Completion Date:

Study Description

Condition: COVID-19

Treatment: Fostamatinib / Placebo

Clinical Study Identifier: NCT04629703

Connect with a study center

  • Clinica Adventista Belgrano

    Buenas Aires,
    Argentina

    Active - Recruiting

  • Clinica Privada Monte Grande S.A

    Buenas Aires,
    Argentina

    Active - Recruiting

  • Clinica Zabala

    Buenas Aires,
    Argentina

    Active - Recruiting

  • Hospital del Bicentenario de Esteban Echeverria

    Buenas Aires,
    Argentina

    Active - Recruiting

  • Sanatorio Guemes

    Buenas Aires,
    Argentina

    Active - Recruiting

  • Sanatorio Sagrado Corazon

    Buenas Aires,
    Argentina

    Active - Recruiting

  • Hospital De Infecciosas, Dr. Francisco Javier Muniz

    Buenos Aires,
    Argentina

    Active - Recruiting

  • Hospital de Alta Complejidad Cuenca Alta, Dr N Kirchner

    Buenos Aires,
    Argentina

    Active - Recruiting

  • Clinica Chutro

    Cordoba,
    Argentina

    Active - Recruiting

  • Hospital San Roque

    Cordoba,
    Argentina

    Active - Recruiting

  • Sanatorio Mayo Privado S.A.

    Cordoba,
    Argentina

    Active - Recruiting

  • Hospital Lencinas City Mendoza / Province Mendoza

    Godoy Cruz,
    Argentina

    Active - Recruiting

  • Corporación Meidca de General San Martin

    San Martin,
    Argentina

    Active - Recruiting

  • Hospital Alemao Oswaldo Cruz (HAOC)

    Bela Vista,
    Brazil

    Active - Recruiting

  • Hospital Luxenburgo

    Belo Horizonte,
    Brazil

    Active - Recruiting

  • Hospital Dia Do Pulmao

    Blumenau,
    Brazil

    Active - Recruiting

  • Sociedade Hospital Angelina Caron

    Campina Grande do Sul,
    Brazil

    Active - Recruiting

  • Pontificia Universidade Catolica de Campinas (PUC-CAMP) - Hospital e Maternidade Celso Pierro (HMCP)

    Campinas,
    Brazil

    Active - Recruiting

  • Universidade Federal de Goias (UFG) - Hospital das Clinicas (HC)

    Goiania,
    Brazil

    Active - Recruiting

  • Hospital Bandeirantes (Leforte)

    Liberdade,
    Brazil

    Active - Recruiting

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre,
    Brazil

    Active - Recruiting

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre,
    Brazil

    Active - Recruiting

  • Fundação Faculdade Reg. de Med de SJRP

    Sao Jose Do Rio Preto,
    Brazil

    Active - Recruiting

  • Clinica de Alergia Martti Antila

    Sorocaba,
    Brazil

    Active - Recruiting

  • Instituto de Investigación del Hospital Cardiológica de Aguascalientes

    Aguascalientes,
    Mexico

    Active - Recruiting

  • Nuevo Hospital Civil de Guadalajara, DR. Juan I. Menchaca

    Guadalajara,
    Mexico

    Active - Recruiting

  • Unidad Medica de Servicio Integral UMSI

    Monterrey,
    Mexico

    Active - Recruiting

  • Hospital Civil de Culiacan

    Sinaloa,
    Mexico

    Active - Recruiting

  • ECTURAE SMO

    Toluca,
    Mexico

    Active - Recruiting

  • University of California Irvine Medical Center (UCIMC)

    Orange, California
    United States

    Active - Recruiting

  • Alternative Research Associates, LLC

    Haileah, Florida
    United States

    Active - Recruiting

  • Loyola University Chicago

    Maywood, Illinois
    United States

    Active - Recruiting

  • Harvard Medical School - Brigham and Women's Hospital (BWH)

    Boston, Massachusetts
    United States

    Active - Recruiting

  • Ascension Medical Group - St. John Clinic Infectious Disease

    Tulsa, Oklahoma
    United States

    Active - Recruiting

  • Houston Methodist Hospital

    Houston, Texas
    United States

    Active - Recruiting

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