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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04629703
• Other study ID #: C-935788-061
• Status: Completed
• Phase: Phase 3
• Start date: March 25, 2021
• Est. completion date: September 5, 2022

Study information

• Verified date: August 2023
• Source: Rigel Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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.

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19
• Covid19
• Pneumonia
• Pneumonia, Viral
• SARS (Severe Acute Respiratory Syndrome)
• SARS Pneumonia
• SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• Fostamatinib
Fostamatinib (150 mg twice daily) for 14 days and Standard of Care
• Placebo
Placebo (twice daily) for 14 days and Standard of Care

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Rigel Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Mexico, 

Outcome

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