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CNM-ZnAg

Phase 2

Covid19 | Small molecule | Infectious Disease |Clene Inc.|Last Updated: Apr 3, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment296

FDA Designations

No designations recorded

Clinical trial landscape

CNM-ZnAg · 1 trial · 1 indication

Phase 2 1
NCT04610138Study of ZnAg Liquid Solution to Treat COVID-19 Symptomatic ParticipantsCovid19
COMPLETED296 Analytics
PHASE2COMPLETED
Study of ZnAg Liquid Solution to Treat COVID-19 Symptomatic Participants
Covid19Unlock trial analytics

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 to 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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Frequently asked questions about CNM-ZnAg

What is CNM-ZnAg used for?

CNM-ZnAg is an investigational small molecule being studied for the treatment of symptomatic COVID-19. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes CNM-ZnAg?

CNM-ZnAg is being developed by Clene Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CLNN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in COVID-19 patients.

What phase is CNM-ZnAg in?

CNM-ZnAg is in Phase 2 clinical development. It is an investigational drug and has not yet received regulatory approval. A Phase 2 trial has been completed to assess its effects in symptomatic COVID-19 participants.

What clinical trials is CNM-ZnAg in?

CNM-ZnAg has one completed Phase 2 clinical trial, identified as NCT04610138, titled 'Study of ZnAg Liquid Solution to Treat COVID-19 Symptomatic Participants.' This randomized, double-blind, placebo-controlled trial enrolled 296 participants aged 40 years and older in Brazil.

Is CNM-ZnAg FDA approved?

CNM-ZnAg is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for COVID-19. The drug has completed a clinical trial, but it remains unapproved and is still being evaluated for safety and efficacy.