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CNM-ZnAg

Phase 2

Covid19 | Small molecule | Infectious Disease |Clene Inc.|Last Updated: Apr 3, 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_CONTROLLED
Total Trials1
Total Enrollment296
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04610138Study of ZnAg Liquid Solution to Treat COVID-19 Symptomatic ParticipantsPHASE2 COMPLETED 296Jun 1, 2021Oct 20, 2022Apr 3, 20235 Brazil
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Study Endpoints
Primary Endpoints
Time to substantial alleviation of COVID-19 symptoms.
Up to 28 days.

Time to substantial alleviation of COVID-19 symptoms up to 28-days, over a continuous period ≥ 48 hours (confirmed symptom resolution), defined as PGI-Severity of 'Normal' in Participants whose Baseline PGI-Severity value was 'Mild'; or, a PGI-Severity of 'Normal' or 'Mild' in participants whose Baseline PGI-Severity value was 'Moderate' or 'Severe'.

Secondary Endpoints
Time to complete alleviation of COVID-19 symptoms.
Up to 28 days.
Proportion of participants who are hospitalized, requires hospitalization or are deceased.
Up to 28 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Active treatment with 60 ml low-dose ZnAgEXPERIMENTAL(Zn 6 ug/ml and Ag 10 ug/ml; equivalent to 0.6 mg Ag, 0.36 mg Zn), po q12 hours
Active treatment with 60 ml high-dose ZnAgEXPERIMENTAL(Zn 12 ug/ml and Ag 20 ug/ml; equivalent to 1.2 mg Ag, 0.72 mg Zn), po q12 hours;
60 ml matching placeboPLACEBO_COMPARATOR60 ml matching placebo, po q12 hours
Interventions
NameTypeDescription
CNM-ZnAgDRUGZnAg liquid solution
PlaceboDRUGWater
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Eligibility Criteria
Age Range40 Years — 90 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1. Adults, aged 40 - 90 years (inclusive) 2. Acute onset (within 96 hours of the Baseline visit) of two or more COVID-19 symptoms self-rated as moderate-to-severe, including fever, myalgia, fatigue, chest tightness, chills, cough, diarrhea, gastrointestinal distress, headache, s...

Countries:Brazil
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