Double-Blind, Randomized, Placebo-Controlled, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects
- Conditions
- SARS PneumoniaPneumoniaSARS (Severe Acute Respiratory Syndrome)Pneumonia, ViralSARS-Associated Coronavirus as Cause of Disease Classified ElsewhereCovid19
- Interventions
- Drug: Placebo
- Registration Number
- NCT04629703
- Lead Sponsor
- Rigel Pharmaceuticals
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 280
- ≥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.
- 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 Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo (twice daily for 14 days) + Standard of Care Placebo Placebo (twice daily for 14 days) + Standard of Care Fostamatinib (150 mg twice daily for 14 days) + Standard of Care Fostamatinib Fostamatinib (150 mg twice daily for 14 days) + Standard of Care
- Primary Outcome Measures
Name Time Method Number of days on oxygen from randomization on Day 1 to Day 29 29 days Number of days on oxygen from randomization on Day 1 to Day 29
- Secondary Outcome Measures
Name Time Method Proportion of subjects alive by Day 60 and oxygen free on Day 29 60 days Proportion of subjects alive by Day 60 and oxygen free on Day 29
Number of days in the ICU from randomization on Day 1 to Day 29 29 days Number of days in the ICU from randomization on Day 1 to Day 29
Mean change from baseline over time in clinical status score using the 8-point ordinal scale, to the average from Day 5 through Day 15. 10 days Mean change from baseline over time in clinical status score using the 8-point ordinal
All-cause mortality by Day 29. 29 days All-cause mortality by Day 29.
Time to first sustained hospital discharge by Day 29. (A discharge is defined as sustained when no readmission occurs by Day 29 after the discharge). 29 days Time to first sustained hospital discharge by Day 29. (A discharge is defined as sustained when no readmission occurs by Day 29 after the discharge).
All-cause mortality by Day 60 60 days All-cause mortality by Day 60
Proportion of subjects alive by Day 29 and oxygen free on Day 29. 29 days Proportion of subjects alive by Day 29 and oxygen free on Day 29.
Trial Locations
- Locations (45)
Hospital Luxenburgo-Associação Mário Penna
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre - ISCMPA
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Alternative Research Associates, LLC
🇺🇸Miami, Florida, United States
Henry Ford
🇺🇸Detroit, Michigan, United States
Harvard Medical School- Bringham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Houston Methodist Research Institute
🇺🇸Houston, Texas, United States
Sanatorio Mayo Privado
🇦🇷Córdoba, Argentina
Hospital San Roque
🇦🇷Córdoba, Argentina
Icaro Investigaciones en Medicina
🇲🇽Chihuahua, Mexico
Hospital Ángeles Roma
🇲🇽Mexico, Mexico
George Washington University Hospital
🇺🇸Washington, District of Columbia, United States
Clinica Chutro
🇦🇷Cordoba, CP, Argentina
Corporacion Medica de General San Martin
🇦🇷San Martin, Provincia De Buenos Aires, Argentina
Hospital Del Bicentenario - Dr. Luis Federico Leloir
🇦🇷Buenos Aires, Argentina
Hospital Lencinas
🇦🇷Godoy Cruz, Mendoza, Argentina
The American British Cowdray Medical Center I.A.P.
🇲🇽Mexico City, Mexico
Nuevo Hospital Civil de Guadalajara
🇲🇽Guadalajara, Mexico
Hospital Civil de Culiacan
🇲🇽Sinaloa, Mexico
University of California Irvine
🇺🇸Orange, California, United States
Ascension Medical Group- St. John Clinic Infectious Disease
🇺🇸Tulsa, Oklahoma, United States
Hospital de Alta Complejidad Cuenta Alta
🇦🇷Buenos Aires, Argentina
Sanatorio Guemes
🇦🇷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
Hospital das Clínicas da Universidade Federal de Goiás (HC/UFG)
🇧🇷Goiânia, Goiás, Brazil
Hospital Universitario de Maringa
🇧🇷Maringá, Parana, Brazil
Sanatorio Sagrado Corazon
🇦🇷Buenos Aires, Argentina
Hosp. Angelina Caron
🇧🇷Campina Grande do Sul, Paraná, 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
Clinica de Alergia Martti Antila S/S Ltda
🇧🇷Sorocaba, Sao Paulo, Brazil
Pontificia Universidade Catolica de Campinas (PUC-CAMP) - Hospital e Maternidade Celso Pierro (HMCP)
🇧🇷Campinas, Sao Paolo, Brazil
Hospital Universitário São Francisco na Providência de Deus
🇧🇷Braganca Paulista, Sao Paulo, Brazil
Unidad Medica para la Salud Integral (UMSI)
🇲🇽Monterrey, Nuevo Leon, Mexico
Hospital Bandeirantes (LeForte)
🇧🇷Liberdade, Sao Paolo, Brazil
Fundação Faculdade Reg. de Med de SJRP
🇧🇷São José Do Rio Preto, Sao Paulo, Brazil
Hospital Alemão Oswaldo Cruz (HAOC)
🇧🇷Bela Vista, Sao Paolo, Brazil
Star Medica Vivo Bicentenario
🇲🇽Nezahualcóyotl, Mex, Mexico
Köhler & Milstein Research
🇲🇽Mérida, Yucatán, Mexico
Hospital Cardiologica Aguascalientes
🇲🇽Aguascalientes, Mexico
Centro Medico Issemym Toluca
🇲🇽Metepec, Mexico
CEPREP Centro de Prevención y Rehabilitación de Enfermedades Pulmonares Crónicas
🇲🇽Nuevo León, Mexico
Loyola University Medical School
🇺🇸Maywood, Illinois, United States