Study of ZnAg Liquid Solution to Treat COVID-19 Symptomatic Participants
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|ClinicalTrials.gov Identifier: NCT04610138|
Recruitment Status : Not yet recruiting
First Posted : October 30, 2020
Last Update Posted : February 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Drug: CNM-ZnAg Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||276 participants|
|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)|
|Masking Description:||All participants, investigators, and coordinators will be blinded to the investigational product. The study data will remain blinded until database lock and authorization of data release according to standard operating procedures.|
|Official Title:||A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of ZnAg Liquid Solution to Treat COVID-19 in Acutely Symptomatic Non-Hospitalized Participants|
|Estimated Study Start Date :||February 2021|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||August 2021|
Experimental: 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
ZnAg liquid solution
Experimental: 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;
ZnAg liquid solution
Placebo Comparator: 60 ml matching placebo
60 ml matching placebo, po q12 hours
- The proportion of participants who require COVID-19 related hospitalization, are hospitalized for COVID-19 related medical support, or are deceased within 28-days following randomization. [ Time Frame: Up to 28 days. ]Hospitalization will be determined by Investigator's clinical judgement. Where applicable, Investigators should follow local recommendations for hospitalization of patients with COVID-19 within their institution.
- Time to substantial alleviation of COVID-19 symptoms. [ Time Frame: Up to 28 days. ]Confirmed symptom resolution over a continuous period ≥ 48 hours, 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'.
- Number of alive hospital free days at Day 28. [ Time Frame: 28 days ]Days from baseline participant remains alive.
- Mean change from Baseline to Day 14, Day 21, and Day 28 in SARS-CoV-2 viral load. [ Time Frame: Up to 28 days ]Cycle Thresholds assessed by RT-qPCR.
- Change from Baseline to Day 8, Day 14, Day 21, and 28 in the slope of oxygen saturation levels (SpO2) assessed per protocol. [ Time Frame: up to 28 days ]Oxygen saturation will be obtained after the participant has been resting for 5 minutes.
- Clinical Global Impression (CGI) Severity and Change measures from Baseline to Day 8, Day 14, Day 21, and 28. [ Time Frame: Up to 28 days ]Measured by changes in participant rated Clinical Global Impression.
- Patient Global Impression (PGI) Severity and Change measures from Baseline to Day 8, Day 14, Day 21, and 28. [ Time Frame: Up to 28 days ]Measured by changes in participant rated Patient Global Impression.
- Change in the area under the curve for Net Symptom Burden from Baseline to Day 8, Day 14, Day 21, and 28. [ Time Frame: Up to 28 days ]Summary measure integrating semi-daily serial assessments of a subject's symptom count and severity over the duration of the study.
- Change in clinical status from Baseline to Day 8, Day 14, Day 21, and Day 28. [ Time Frame: Up to 28 days ]Assessed by the Clinical Status Ordinal Scale established in the remdesivir ACTT study. Scale is 1-8, with 1 being the least severe and 8 being the most severe (death).
- All-cause mortality rate at Day 28. [ Time Frame: 28 days ]Rate of deceased participants at day 28.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04610138
|Contact: Renata Lourencini||+55 (11) email@example.com|
|Contact: Robert Glanzman, MDfirstname.lastname@example.org|