A Phase 3 interventional study of Fostamatinib and Placebo in Covid19, SARS (Severe Acute Respiratory Syndrome) and SARS Pneumonia, sponsored by Rigel Pharmaceuticals. Completed at 47 sites in 4 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-08-18.
Sponsored by Rigel Pharmaceuticals · Phase 3, Interventional, and Treatment
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 280 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Rigel Pharmaceuticals is the lead sponsor of 27 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fostamatinib (150 mg twice daily for 14 days) + Standard of Care
Drug: Fostamatinib
Placebo (twice daily for 14 days) + Standard of Care
Drug: Placebo
Fostamatinib (150 mg twice daily) for 14 days and Standard of Care
Also known as: Fostamatinib disodium
Placebo (twice daily) for 14 days and Standard of Care
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
Time frame: 29 days
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
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 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.
All-cause mortality by Day 29.
Time frame: 29 days
All-cause mortality by Day 60
All-cause mortality by Day 60
Time frame: 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.
Time frame: 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
Time frame: 60 days
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Rigel Pharmaceuticals