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

Rigel Pharmaceuticals280 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

280

Conditions

Covid19 SARS (Severe Acute Respiratory Syndrome)SARS Pneumonia SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (47)

University of California Irvine

Orange, California, United States

George Washington University Hospital

Washington D.C., District of Columbia, United States

Alternative Research Associates, LLC

Hialeah, Florida, United States

Alternative Research Associates, LLC

Miami, Florida, United States

Loyola University Medical School

Maywood, Illinois, United States

Outcomes

Primary Outcomes

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

Time frame: 29 days

Secondary Outcomes

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.

Mean change from baseline over time in clinical status score using the 8-point ordinal

Time frame: 10 days

Number of days in the ICU from randomization on Day 1 to Day 29

Time frame: 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).

Time frame: 29 days

All-cause mortality by Day 29.

Time frame: 29 days

All-cause mortality by Day 60

Time frame: 60 days

Proportion of subjects alive by Day 29 and oxygen free on Day 29.

Time frame: 29 days

Proportion of subjects alive by Day 60 and oxygen free on Day 29

Time frame: 60 days

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

Overview

Conditions

Interventions

Eligibility

Locations (47)

Outcomes

Primary Outcomes

Secondary Outcomes