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

Phase 3

Completed

• Conditions: SARS Pneumonia; Pneumonia; SARS (Severe Acute Respiratory Syndrome); Pneumonia, Viral; SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere; Covid19
• Interventions: Drug: Placebo; Drug: Fostamatinib

• Registration Number: NCT04629703
• Lead Sponsor: Rigel Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2020-11-13
• Study First Submitted QC: 2020-11-13
• Study First Posted: 2020-11-16
• Study Start: 2021-03-25
• Primary Completion: 2022-09-05
• Study Completion: 2022-09-05
• Status Verified: 2023-08
• Disposition First Submitted: 2023-08-15
• Last Update Submitted: 2023-08-15
• Disposition First Posted: 2023-08-18
• Last Update Posted: 2023-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (twice daily for 14 days) + Standard of Care	Placebo	Placebo (twice daily for 14 days) + Standard of Care
Fostamatinib (150 mg twice daily for 14 days) + Standard of Care	Fostamatinib	Fostamatinib (150 mg twice daily for 14 days) + Standard of Care

Primary Outcome Measures

Name	Time	Method
Number of days on oxygen from randomization on Day 1 to Day 29	29 days	Number of days on oxygen from randomization on Day 1 to Day 29

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects alive by Day 60 and oxygen free on Day 29	60 days	Proportion of subjects alive by Day 60 and oxygen free on Day 29
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	Mean change from baseline over time in clinical status score using the 8-point ordinal
All-cause mortality by Day 29.	29 days	All-cause mortality by Day 29.
Number of days in the ICU from randomization on Day 1 to Day 29	29 days	Number of days in the ICU from randomization on Day 1 to Day 29
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	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).
All-cause mortality by Day 60	60 days	All-cause mortality by Day 60
Proportion of subjects alive by Day 29 and oxygen free on Day 29.	29 days	Proportion of subjects alive by Day 29 and oxygen free on Day 29.

Trial Locations

Locations (45)

University of California Irvine; 🇺🇸 Orange, California, United States

George Washington University Hospital; 🇺🇸 Washington, District of Columbia, 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

Clinica Chutro; 🇦🇷 Cordoba, CP, Argentina

Hospital Lencinas; 🇦🇷 Godoy Cruz, Mendoza, Argentina

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