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

Rigel Pharmaceuticals

Status and phase: Completed; Phase 3

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

Treatments: Drug: Fostamatinib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04629703

C-935788-061

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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280 participants in 2 patient groups, including a placebo group

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

Active Comparator group

Description:

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

Treatment:

Drug: Fostamatinib

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

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo