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.
Drug: CNM-ZnAg
ZnAg liquid solution
Drug: Placebo
Water
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).
PROCAPE
Santo Amaro, Recife, Brazil
Projeto Praca Onze
Centro, Rio De Janeiro, Brazil
IBPClin
Gloria, Rio De Janeiro, Brazil
Casa de Saúde
Campinas, Sau Paulo, Brazil
IPECC
Sao Paulo, State Of Sau Paulo, Brazil