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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Fostamatinib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fostamatinib (150 mg twice daily for 14 days) + Standard of Care<br>Fostamatinib (150 mg twice daily for 14 days) + Standard of Care | Drug: Fostamatinib<br>* Fostamatinib (150 mg twice daily) for 14 days and Standard of Care<br>* Other names: Fostamatinib disodium;|
| Placebo Comparator: Placebo (twice daily for 14 days) + Standard of Care<br>Placebo (twice daily for 14 days) + Standard of Care | Drug: Placebo<br>* Placebo (twice daily) for 14 days and Standard of Care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days on oxygen from randomization on Day 1 to Day 29 | Number of days on oxygen from randomization on Day 1 to Day 29 | 29 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID19, SARS-Associated Coronavirus Pneumonia, Pneumonia, Viral