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Fostamatinib

Phase 3

Covid19 | Small molecule | Infectious Disease |Rigel Pharmaceuticals, Inc.|Last Updated: Aug 18, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment280
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04629703Double-Blind, Randomized, Placebo-Controlled, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 SubjectsPHASE3 COMPLETED 280Mar 25, 2021Sep 5, 2022Aug 18, 202347 United States, Argentina +2
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Study Endpoints
Primary Endpoints
Number of days on oxygen from randomization on Day 1 to Day 29
29 days
Secondary Endpoints
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
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).
29 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Fostamatinib (150 mg twice daily for 14 days) + Standard of CareACTIVE_COMPARATORFostamatinib (150 mg twice daily for 14 days) + Standard of Care
Placebo (twice daily for 14 days) + Standard of CarePLACEBO_COMPARATORPlacebo (twice daily for 14 days) + Standard of Care
Interventions
NameTypeDescription
FostamatinibDRUGFostamatinib (150 mg twice daily) for 14 days and Standard of Care
PlaceboDRUGPlacebo (twice daily) for 14 days and Standard of Care
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Eligibility Criteria
Age Range18 Years — 100 Years
SexALL
Healthy VolunteersNo
Study Sites47

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...

Countries:United StatesArgentinaBrazilMexico
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