NCT04629703

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

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

COMPLETED

NCT ID:

NCT04629703

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

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

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.

Eligibility

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.

Disease(s) and\or Condition(s)

Covid19

SARS (Severe Acute Respiratory Syndrome)

SARS Pneumonia

SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere

Pneumonia

Pneumonia, Viral

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: Fostamatinib
- Description: Fostamatinib (150 mg twice daily) for 14 days and Standard of Care
- Arm Group Labels: Fostamatinib (150 mg twice daily for 14 days) + Standard of Care
- Type: DRUG
- Name: Placebo
- Description: Placebo (twice daily) for 14 days and Standard of Care
- Arm Group Labels: Placebo (twice daily for 14 days) + Standard of Care

Sponsor

Rigel Pharmaceuticals