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LY3819253

Phase 3

Covid19 | Monoclonal antibody | Infectious Disease |Pfizer, Inc.|Last Updated: Aug 25, 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_CONTROLLEDDMC
Total Trials1
Total Enrollment2,753
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04501978ACTIV-3: Therapeutics for Inpatients With COVID-19PHASE3 COMPLETED 2,753Aug 4, 2020Jul 14, 2023Aug 25, 2023135 United States, Denmark +8
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Study Endpoints
Primary Endpoints
Time from randomization to sustained recovery
Up to Day 90

Sustained recovery defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90.

Secondary Endpoints
All-cause mortality
Thru Day 90
Composite of time to sustained recovery and mortality
Thru Day 90
Days alive outside short-term acute care hospital
Up to Day 90
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ACTIV-3 Drug plus SOCEXPERIMENTALParticipants in this study will be randomized to receive one of the ACTIV-3 drug treatments plus Standard of Care (SOC) or placebo plus SOC
Placebo plus SOCPLACEBO_COMPARATORThe placebo arm may be pooled across more than one experimental arm if multiple investigational drugs are available to be tested at the same time. If it is not possible to use matching placebo over more than one experimental arm, additional placebo arms will be included in the study
Interventions
NameTypeDescription
LY3819253BIOLOGICALParticipants are no longer being randomized to this intervention.
PlaceboDRUGCommercially available 0.9% sodium chloride solution. Administered by IV infusion
RemdesivirBIOLOGICALProvided to all study participants as SOC unless contraindicated for an individual patient.
VIR-7831BIOLOGICALParticipants are no longer being randomized to this intervention.
BRII-196/BRII-198BIOLOGICALParticipants are no longer being randomized to this intervention.
AZD7442BIOLOGICALParticipants are no longer being randomized to this intervention.
MP0420DRUGParticipants are no longer being randomized to this intervention.
PF-07304814DRUG250 mg per day for 5 days. Administered as a constant rate intravenous infusion. Suspended: Participants are not currently being randomized to this intervention.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites135

Inclusion Criteria: * Signed informed consent. * Positive test for COVID-19 and progressive disease suggestive of ongoing COVID-19 infection. * Symptoms of COVID-19 for ≤ 12 days. * Require admission to hospital for acute medical care (not for purely public health or quarantine purposes). Exclusio...

Countries:United StatesDenmarkGreeceNigeriaPolandSingaporeSpainSwitzerlandUgandaUnited Kingdom
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