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.
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.
Drug: Fostamatinib
Fostamatinib (150 mg twice daily) for 14 days and Standard of Care
Other Name: Fostamatinib disodium
Drug: Placebo
Placebo (twice daily) for 14 days and Standard of Care
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.
University of California Irvine
Orange, California, United States
George Washington University Hospital
Washington, 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
Clinica Chutro
Cordoba, CP, Argentina
Hospital Lencinas
Godoy Cruz, Mendoza, Argentina
Corporacion Medica de General San Martin
San Martin, Provincia De Buenos Aires, 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
Hospital Universitario de Maringa
Maringá, Parana, Brazil
Hosp. Angelina Caron
Campina Grande do Sul, Paraná, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre - ISCMPA
Porto Alegre, Rio Grande Do Sul, Brazil
Hospital des clinicas de porto alegre - Centro de pequisas clinicas
Porto Alegre,, RS, Brazil
Complexo de Prevenção, Diagnóstico, Terapia e Reabilitação Respiratória LTDA
Blumenau, Santa Catarina, Brazil
Hospital Alemão Oswaldo Cruz (HAOC)
Bela Vista, Sao Paolo, Brazil
Pontificia Universidade Catolica de Campinas (PUC-CAMP) - Hospital e Maternidade Celso Pierro (HMCP)
Campinas, Sao Paolo, Brazil
Hospital Bandeirantes (LeForte)
Liberdade, Sao Paolo, Brazil
Hospital Universitário São Francisco na Providência de Deus
Braganca Paulista, Sao Paulo, Brazil
Clinica de Alergia Martti Antila S/S Ltda
Sorocaba, Sao Paulo, Brazil
Fundação Faculdade Reg. de Med de SJRP
São José Do Rio Preto, Sao Paulo, Brazil
Star Medica Vivo Bicentenario
Nezahualcóyotl, Mex, Mexico
Unidad Medica para la Salud Integral (UMSI)
Monterrey, Nuevo Leon, Mexico
Köhler & Milstein Research
Mérida, Yucatán, Mexico
Hospital Cardiologica Aguascalientes
Aguascalientes, Mexico
Icaro Investigaciones en Medicina
Chihuahua, Mexico
Nuevo Hospital Civil de Guadalajara
Guadalajara, Mexico
Centro Medico Issemym Toluca
Metepec, Mexico
The American British Cowdray Medical Center I.A.P.
Mexico City, Mexico
Hospital Ángeles Roma
Mexico, Mexico
CEPREP Centro de Prevención y Rehabilitación de Enfermedades Pulmonares Crónicas
Nuevo León, Mexico
Hospital Civil de Culiacan
Sinaloa, Mexico
Hospital Civil de Culiacan
Sinaloa, Mexico