Double-Blind, Randomized, Placebo-Controlled, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects
1 other identifier
interventional
280
4 countries
47
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 covid19
Started Mar 2021
Typical duration for phase_3 covid19
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2020
CompletedFirst Posted
Study publicly available on registry
November 16, 2020
CompletedStudy Start
First participant enrolled
March 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 5, 2022
CompletedAugust 18, 2023
August 1, 2023
1.4 years
November 13, 2020
August 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of days on oxygen from randomization on Day 1 to Day 29
Number of days on oxygen from randomization on Day 1 to Day 29
29 days
Secondary Outcomes (7)
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
Number of days in the ICU from randomization on Day 1 to Day 29
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).
29 days
All-cause mortality by Day 29.
29 days
All-cause mortality by Day 60
60 days
- +2 more secondary outcomes
Study Arms (2)
Fostamatinib (150 mg twice daily for 14 days) + Standard of Care
ACTIVE COMPARATORFostamatinib (150 mg twice daily for 14 days) + Standard of Care
Placebo (twice daily for 14 days) + Standard of Care
PLACEBO COMPARATORPlacebo (twice daily for 14 days) + Standard of Care
Interventions
Fostamatinib (150 mg twice daily) for 14 days and Standard of Care
Placebo (twice daily) for 14 days and Standard of Care
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
University of California Irvine
Orange, California, 92868, United States
George Washington University Hospital
Washington D.C., District of Columbia, 20037, United States
Alternative Research Associates, LLC
Hialeah, Florida, 33012, United States
Alternative Research Associates, LLC
Miami, Florida, 33143, United States
Loyola University Medical School
Maywood, Illinois, 60600, United States
Harvard Medical School- Bringham and Women's Hospital
Boston, Massachusetts, 02115, United States
Henry Ford
Detroit, Michigan, 48202, United States
Ascension Medical Group- St. John Clinic Infectious Disease
Tulsa, Oklahoma, 74101, United States
Houston Methodist Research Institute
Houston, Texas, 77030, United States
Corporacion Medica de General San Martin
San Martín, Buenos Aires, CP 1650, Argentina
Clinica Chutro
Córdoba, CP, EPU5000, Argentina
Hospital Lencinas
Godoy Cruz, Mendoza Province, PC: 5547, Argentina
Hospital de Alta Complejidad Cuenta Alta
Buenos Aires, B1814, Argentina
Hospital Del Bicentenario - Dr. Luis Federico Leloir
Buenos Aires, B1842, Argentina
Clinica Zabala
Buenos Aires, C1426, 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, 74605, Brazil
Hospital Luxenburgo-Associação Mário Penna
Belo Horizonte, Minas Gerais, 30380, Brazil
Hosp. Angelina Caron
Campina Grande do Sul, Paraná, 83430-000, Brazil
Hospital Universitario de Maringa
Maringá, Paraná, 87083, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre - ISCMPA
Porto Alegre, Rio Grande do Sul, 90020, Brazil
Hospital des clinicas de porto alegre - Centro de pequisas clinicas
Porto Alegre, Rio Grande do Sul, 90035 - 903, Brazil
Complexo de Prevenção, Diagnóstico, Terapia e Reabilitação Respiratória LTDA
Blumenau, Santa Catarina, 89030, Brazil
Hospital Alemão Oswaldo Cruz (HAOC)
Bela Vista, São Paulo, 01323, Brazil
Hospital Universitário São Francisco na Providência de Deus
Bragança Paulista, São Paulo, 12916-542, Brazil
Pontificia Universidade Catolica de Campinas (PUC-CAMP) - Hospital e Maternidade Celso Pierro (HMCP)
Campinas, São Paulo, 13060, Brazil
Hospital Bandeirantes (LeForte)
Liberdade, São Paulo, 01506, Brazil
Fundação Faculdade Reg. de Med de SJRP
São José do Rio Preto, São Paulo, 15090, Brazil
Clinica de Alergia Martti Antila S/S Ltda
Sorocaba, São Paulo, 18040, Brazil
Unidad Medica para la Salud Integral (UMSI)
Monterrey, Nuevo León, Mexico
Star Medica Vivo Bicentenario
Nezahualcóyotl, State of Mexico, 57205, Mexico
Köhler & Milstein Research
Mérida, Yucatán, 97070, Mexico
Hospital Cardiologica Aguascalientes
Aguascalientes, Mexico
Icaro Investigaciones en Medicina
Chihuahua City, CP:3100, 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
México, Mexico
CEPREP Centro de Prevención y Rehabilitación de Enfermedades Pulmonares Crónicas
Nuevo León, Mexico
Hospital Civil de Culiacan
Sinaloa, 80230, Mexico
Hospital Civil de Culiacan
Sinaloa, Mexico
Related Publications (1)
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PMID: 34473343DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2020
First Posted
November 16, 2020
Study Start
March 25, 2021
Primary Completion
September 5, 2022
Study Completion
September 5, 2022
Last Updated
August 18, 2023
Record last verified: 2023-08