Covid19, Pneumonia, Pneumonia, Viral, SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere, SARS Pneumonia, SARS (Severe Acute Respiratory Syndrome)
Conditions
Keywords
COVID19, SARS-Associated Coronavirus Pneumonia, Pneumonia, Viral
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.
Interventions
DRUGFostamatinib
Fostamatinib (150 mg twice daily) for 14 days and Standard of Care
DRUGPlacebo
Placebo (twice daily) for 14 days and Standard of Care
Sponsors
Rigel Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 29. | 29 days | All-cause mortality by 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 |
| 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. |
| 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 |
| All-cause mortality by Day 60 | 60 days | All-cause mortality by Day 60 |
Countries
Argentina, Brazil, Mexico, United States
Outcome results
None listed