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

COMPLETEDPHASE3

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

NCT04629703•Rigel Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

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.

Locations (47)

University of California Irvine

Orange, California, United States

George Washington University Hospital

Washington D.C., 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

Corporacion Medica de General San Martin

San Martín, Buenos Aires, Argentina

Key Dates

Start Date

March 25, 2021

Primary Completion Date

September 5, 2022

Completion Date

September 5, 2022

Last Updated

August 18, 2023

Enrollment

280

ACTUAL participants

Conditions

Covid19SARS (Severe Acute Respiratory Syndrome)SARS PneumoniaSARS-Associated Coronavirus as Cause of Disease Classified ElsewherePneumoniaPneumonia, Viral

Interventions

Fostamatinib

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

The Effect of the Covid-19 Pandemic Among Operated Patients

The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients

Covid-19 and Influenza Oral Vaccine Study

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