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Paxlovid

Phase 3

COVID-19 | Small molecule | Infectious Disease |Unity Biotechnology, Inc.|Last Updated: May 16, 2025

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
RandomizedNO_TREATMENT_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment797
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05614349Canadian Adaptive Platform Trial of Treatments for COVID-19 in Community SettingsPHASE3 ACTIVE NOT_RECRUITING 797Jan 16, 2023Jun 28, 2025May 16, 20256 Canada
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Study Endpoints
Primary Endpoints
All-cause hospitalization or death rate
Day 28
Secondary Endpoints
Time to recovery
Days 0-14
Symptom severity
Days 0-28
Rate of Post-acute sequelae of SARS-CoV-2
90 days and 36 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PaxlovidEXPERIMENTALNirmatrelvir/ritonavir (Paxlovid™) BD x 5 days (this arm has been closed of Sept 30th 2024)
Control groupNO_INTERVENTIONUsual care (i.e., supportive care and symptom relief)
Antioxidant Therapy - Intervention (arm 3)EXPERIMENTALAntioxidant therapy (comprising of selenium, zinc, lycopene, and vitamin C)
Interventions
NameTypeDescription
PaxlovidDRUGThis adaptive platform trial will assess therapeutics for SARS-CoV-2 in out-patient settings. The first intervention arm is Paxlovid.
AntioxidantDRUGAntioxidant therapy (comprising of selenium, zinc, lycopene, and vitamin C)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Age 50 years and older or 18-49 with 1 or more chronic high-risk medical conditions, and/or immunosuppression: chronic respiratory disease (including COPD, cystic fibrosis and asthma requiring at least daily use of preventative and/or reliever medication); chronic heart or vas...

Countries:Canada
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05614349primaryCompletionDate: changed
LOWMay 24, 2026NCT05614349studyFirstPostDate: changed