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

  • STATUS
    Recruiting
  • End date
    May 6, 2022
  • participants needed
    308
  • sponsor
    Rigel Pharmaceuticals
Updated on 6 December 2021
respiratory failure
covid-19
diagnostic procedures

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

Details
Condition SARS coronavirus, Severe Acute Respiratory Syndrome, Lung Disease, severe acute respiratory syndrome (sars), Viral pneumonia, pneumonitis, SARS Pneumonia, sars, COVID19, lung inflammation, Throat and Tonsil Infections, Pulmonary Disease, Pneumonia (Pediatric), SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere, Upper respiratory infection, pneumoniae, Pneumonia
Treatment Placebo, fostamatinib
Clinical Study IdentifierNCT04629703
SponsorRigel Pharmaceuticals
Last Modified on6 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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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