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

  • STATUS
    Recruiting
  • sponsor
    Rigel Pharmaceuticals, Inc.
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Updated on 10 December 2021
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covid-19

Summary

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 without respiratory failure and with certain high risk prognostic factors, as measured by the change in clinical status score.

Description

Condition: COVID-19
Treatment: Fostamatinib / Placebo 
Clinical Study Identifier: NCT04629703

Details
Condition Pulmonary/Respiratory Diseases, Respiratory Failure, Viral Infections, Vaccines, Influenza, COVID-19, Infections and Infectious Diseases
Clinical Study IdentifierTX289042
SponsorRigel Pharmaceuticals, Inc.
Last Modified on10 December 2021

Eligibility

 Yes No Not Sure

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 (e. g., 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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