Study of ZnAg Liquid Solution to Treat COVID-19 Symptomatic Participants
Study of ZnAg Liquid Solution to Treat COVID-19 Symptomatic Participants
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.
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.
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, sore throat, congestion,
 or runny nose, ageusia, anosmia, nausea, tingling or numbness in the extremities, or
 shortness of breath.

 3. Laboratory-confirmed SARS-CoV-2 infection as determined by positive PCR in a sample
 collected ≤ 96 hours prior to the Baseline visit.

 4. PGI-Severity and CGI-Severity assessments of 'Mild', 'Moderate, or 'Severe' at the
 Screening visit (e.g., cannot be 'Normal').

 5. Participant (or legally authorized representatives) provides informed consent prior to
 the initiation of any study procedures.

 6. Participant is willing and able to follow all study procedures and assessments
 according to the study protocol.

 7. Participant is able to consume 60 ml of fluid orally twice daily.

 8. Women of childbearing potential must agree to either abstinence or use at least one
 primary form of contraception, not including hormonal contraception from the time of
 screening through the end of study.

 Exclusion Criteria:

 1. Unable or unwilling to take ZnAg liquid solution or matching placebo as directed.

 2. Hospitalized prior to Baseline for COVID-19 management.

 3. Need for hospitalization and/or ventilatory support at Baseline.

 4. The emergence of any disease during study, other than COVID-19 that could better
 explain the participants' signs and symptoms.

 5. Severe disease: respiratory distress, or requiring supplemental oxygen, or SpO2 ≤ 93%
 on room air, or tachypnea (respiratory rate ≥ 30 breaths/min) at Baseline.

 6. History or presence of serious or acute heart disease such as uncontrolled cardiac
 dysrhythmia or arrhythmia, uncontrolled angina pectoris, cardiomyopathy, or
 uncontrolled congestive heart failure (NYHA class 3 or 4).

 7. Legal incapacity or limited legal capacity.

 8. Women of childbearing potential who do not agree to use either abstinence or at least
 one primary form of contraception, not including hormonal contraception from the time
 of screening through the end of the study.

 9. Pregnant or breastfeeding.

 10. Participation in another clinical study with an investigational product within the
 prior 12 months (per Resolution 251/1997).