Study of ZnAg Liquid Solution to Treat COVID-19 Symptomatic Participants
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-site, randomized, double-blind, placebo-controlled study assessing the
      efficacy and safety of ZnAg liquid solution in symptomatic participants with acute COVID-19
      that are not hospitalized at the time of enrollment.
    

Detailed description: 
      This is a multi-site, randomized, double-blind, placebo-controlled study assessing the
      efficacy and safety of ZnAg liquid solution in symptomatic participants with acute COVID-19
      (PCR documented SARS-CoV-2 infection) that are not hospitalized at the time of enrollment
      (e.g., present to an emergency room without being admitted to the hospital or diagnosed in an
      outpatient clinic setting).

      Participants must have presented with two or more symptoms of acute COVID-19 (within 96 hours
      prior to the Baseline visit) self-reported as moderate or severe at the Baseline visit,
      including fever, myalgia, fatigue, chest tightness, chills, cough, diarrhea, gastrointestinal
      distress, headache, sore throat, congestion or runny nose, ageusia, anosmia, nausea, tingling
      or numbness in the extremities, or shortness of breath. SARS-CoV-2 infection must be
      confirmed by polymerase chain reaction (PCR) testing within 96 hours prior to the Baseline
      visit.

      Participants who meet all inclusion criteria and none of the exclusion criteria and who
      formally consent to participate will be randomized 1:1:2 to receive ZnAg (low dose) : ZnAg
      (high dose) placebo in a double-blind fashion in addition to standard supportive care. Within
      the active treatment arm, participants will be randomized to receive either low or high dose
      ZnAg.

        -  Active treatment with 60 ml low-dose ZnAg (Zn 6 ug/ml and Ag 10 ug/ml; equivalent to 0.6
           mg Ag, 0.36 mg Zn), po q12 hours or;

        -  Active treatment with 60 ml high-dose ZnAg (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 placebo, po q12 hours

      Participants who become clinically unstable during the course of the study (e.g., requiring
      high-flow supplemental oxygen or mechanical ventilatory support) per the judgement of the
      site investigator will be admitted to a hospital and their clinical status (e.g., vital
      status, hospitalization status, respiratory status, COVID-19 ordinal scale) will continue to
      be tracked per protocol.
    

Intervention name(s): CNM-ZnAg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ZnAg liquid solution; Water
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized 1:1:2 to receive ZnAg (low dose): ZnAg (high dose) placebo in a double-blind fashion in addition to standard supportive care. Within the active treatment arm, participants will be randomized to receive either low or high dose ZnAg.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SARS-CoV-2; COVID; COVID-19; Corona Virus