Covid19 Clinical Trial
Official title:
Double-Blind, Randomized, Placebo-Controlled, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects
Verified date | August 2023 |
Source | Rigel Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 280 |
Est. completion date | September 5, 2022 |
Est. primary completion date | September 5, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Argentina | Clinica Adventista Belgrano | Buenos Aires | |
Argentina | Clinica Monte Grande | Buenos Aires | |
Argentina | Clinica Zabala | Buenos Aires | |
Argentina | Hospital de Alta Complejidad Cuenta Alta | Buenos Aires | |
Argentina | Hospital de Infecciosas Dr.Francisco Javier Muñiz | Buenos Aires | |
Argentina | Hospital Del Bicentenario - Dr. Luis Federico Leloir | Buenos Aires | |
Argentina | Sanatorio Guemes | Buenos Aires | |
Argentina | Sanatorio Sagrado Corazon | Buenos Aires | |
Argentina | Clinica Chutro | Cordoba | CP |
Argentina | Hospital San Roque | Córdoba | |
Argentina | Sanatorio Mayo Privado | Córdoba | |
Argentina | Hospital Lencinas | Godoy Cruz | Mendoza |
Argentina | Corporacion Medica de General San Martin | San Martin | Provincia De Buenos Aires |
Brazil | Hospital Alemão Oswaldo Cruz (HAOC) | Bela Vista | Sao Paolo |
Brazil | Hospital Luxenburgo-Associação Mário Penna | Belo Horizonte | Minas Gerais |
Brazil | Complexo de Prevenção, Diagnóstico, Terapia e Reabilitação Respiratória LTDA | Blumenau | Santa Catarina |
Brazil | Hospital Universitário São Francisco na Providência de Deus | Braganca Paulista | Sao Paulo |
Brazil | Hosp. Angelina Caron | Campina Grande do Sul | Paraná |
Brazil | Pontificia Universidade Catolica de Campinas (PUC-CAMP) - Hospital e Maternidade Celso Pierro (HMCP) | Campinas | Sao Paolo |
Brazil | Hospital das Clínicas da Universidade Federal de Goiás (HC/UFG) | Goiânia | Goiás |
Brazil | Hospital Bandeirantes (LeForte) | Liberdade | Sao Paolo |
Brazil | Hospital Universitario de Maringa | Maringá | Parana |
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 | Fundação Faculdade Reg. de Med de SJRP | São José Do Rio Preto | Sao Paulo |
Brazil | Clinica de Alergia Martti Antila S/S Ltda | Sorocaba | Sao Paulo |
Mexico | Hospital Cardiologica Aguascalientes | Aguascalientes | |
Mexico | Icaro Investigaciones en Medicina | Chihuahua | |
Mexico | Nuevo Hospital Civil de Guadalajara | Guadalajara | |
Mexico | Köhler & Milstein Research | Mérida | Yucatán |
Mexico | Centro Medico Issemym Toluca | Metepec | |
Mexico | Hospital Ángeles Roma | Mexico | |
Mexico | The American British Cowdray Medical Center I.A.P. | Mexico City | |
Mexico | Unidad Medica para la Salud Integral (UMSI) | Monterrey | Nuevo Leon |
Mexico | Star Medica Vivo Bicentenario | Nezahualcóyotl | Mex |
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 | |
United States | Harvard Medical School- Bringham and Women's Hospital | Boston | Massachusetts |
United States | Henry Ford | Detroit | Michigan |
United States | Alternative Research Associates, LLC | Hialeah | Florida |
United States | Houston Methodist Research Institute | Houston | Texas |
United States | Loyola University Medical School | Maywood | Illinois |
United States | Alternative Research Associates, LLC | Miami | Florida |
United States | University of California Irvine | Orange | California |
United States | Ascension Medical Group- St. John Clinic Infectious Disease | Tulsa | Oklahoma |
United States | George Washington University Hospital | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Rigel Pharmaceuticals |
United States, Argentina, Brazil, Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | Mean change from baseline over time in clinical status score using the 8-point ordinal | 10 days | |
Secondary | Number of days in the ICU from randomization on Day 1 to Day 29 | Number of days in the ICU from randomization on Day 1 to Day 29 | 29 days | |
Secondary | 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). | 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 | |
Secondary | All-cause mortality by Day 29. | All-cause mortality by Day 29. | 29 days | |
Secondary | All-cause mortality by Day 60 | All-cause mortality by Day 60 | 60 days | |
Secondary | Proportion of subjects alive by Day 29 and oxygen free on Day 29. | Proportion of subjects alive by Day 29 and oxygen free on Day 29. | 29 days | |
Secondary | Proportion of subjects alive by Day 60 and oxygen free on Day 29 | Proportion of subjects alive by Day 60 and oxygen free on Day 29 | 60 days |
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