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

Rigel Pharmaceuticals45 sites in 4 countries280 target enrollmentMarch 25, 2021

ConditionsCovid19 SARS (Severe Acute Respiratory Syndrome)SARS Pneumonia SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere Pneumonia Pneumonia, Viral

InterventionsFostamatinib Placebo

DrugsFostamatinib Placebo

Overview

Phase: Phase 3
Intervention: Fostamatinib
Conditions: Covid19
Sponsor: Rigel Pharmaceuticals
Enrollment: 280
Locations: 45
Primary Endpoint: Number of days on oxygen from randomization on Day 1 to Day 29
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 25, 2021

End Date

September 5, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Rigel Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Fostamatinib (150 mg twice daily for 14 days) + Standard of Care

Intervention: Fostamatinib

Placebo (twice daily for 14 days) + Standard of Care

Intervention: Placebo

Outcomes

Primary Outcomes

Number of days on oxygen from randomization on Day 1 to Day 29

Time Frame: 29 days

Number of days on oxygen from randomization on Day 1 to Day 29

Secondary Outcomes

Proportion of subjects alive by Day 60 and oxygen free on Day 29(60 days)
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.(10 days)
All-cause mortality by Day 29.(29 days)
Number of days in the ICU from randomization on Day 1 to Day 29(29 days)
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)
All-cause mortality by Day 60(60 days)
Proportion of subjects alive by Day 29 and oxygen free on Day 29.(29 days)