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avdoralimab

Phase 2

COVID | Monoclonal antibody | Infectious Disease |Innate Pharma S.A.|Last Updated: May 27, 2021

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 Enrollment208
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04371367Avdoralimab an Anti-C5aR Antibody, in Patients With COVID-19 Severe Pneumonia ( FORCE )PHASE2 COMPLETED 208Apr 27, 2020Mar 30, 2021May 27, 20211 France
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Study Endpoints
Primary Endpoints
Clinical improvement using WHO ordinal scale
day 28

improvement of WHO ordinal scale

Number of ventilator-free days at Day 28 (VFD28)
day 28

Number of days without mechanical ventilation at Day 28 for COVID-19 related Acute Respiratory Distress Syndrome (ARDS) Patients hospitalized in ICU

Secondary Endpoints
Number of participants with treatment-related adverse events
day 28
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
avdoralimabEXPERIMENTALBiological/Vaccine: avdoralimab intravenous administration of avdoralimab Other Names: • IPH5401
PlaceboPLACEBO_COMPARATORintravenous administration of Placebo
Interventions
NameTypeDescription
avdoralimabBIOLOGICALintravenous administration of avdoralimab
PlaceboOTHERintravenous administration of placebo
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * COVID-19 severe pneumonia patients need for oxygen therapy ≥ 5 l/min or high-flow oxygen therapy * COVID-19 related Acute Respiratory Distress Syndrome (ARDS) requiring mechanical ventilation Exclusion Criteria: * Pregnant woman * Uncontrolled sepsis of bacterial or fungal o...

Countries:France
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