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| Name | Class |
|---|---|
| ICL Pharma | UNKNOWN |
| Azidus Brazil | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment with 60 ml low-dose ZnAg | Experimental | (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 ZnAg | Experimental | (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 | Placebo Comparator | 60 ml matching placebo, po q12 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CNM-ZnAg | Drug | ZnAg liquid solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to substantial alleviation of COVID-19 symptoms. | 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'. | Up to 28 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to complete alleviation of COVID-19 symptoms. | Time to complete alleviation of COVID-19 symptoms up to 28- days, over a continuous period ≥ 48 hours (confirmed symptom resolution). | Up to 28 days. |
| Proportion of participants who are hospitalized, requires hospitalization or are deceased. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of alive hospital free days at Day 28. | Days from baseline participant remains alive. | 28 days |
| Mean change from Baseline to Day 8, Day 14, Day 21, and Day 28 in SARS-CoV-2 viral load. | Mean change from Baseline to Day 8, Day 14, Day 21, and Day 28 in SARS-CoV-2 viral load (Cycle Thresholds, Ct) , and time to non-detectable virus levels assessed by RT-qPCR. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PROCAPE | Santo Amaro | Recife | 89020-430 | Brazil | ||
| Projeto Praca Onze |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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.
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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.
| Placebo | Drug | Water |
|
Proportion of participants who are hospitalized, require hospitalization, or are deceased from Baseline to Day 28. 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. |
| Up to 28 days |
| Up to 28 days |
| Change from Baseline to Day 8, Day 14, Day 21, and 28 in the slope of oxygen saturation levels (SpO2) assessed per protocol. | Oxygen saturation will be obtained after the participant has been resting for 5 minutes. | up to 28 days |
| Clinical Global Impression (CGI) Severity and Change measures from Baseline to Day 8, Day 14, Day 21, and 28. | Measured by changes in participant rated Clinical Global Impression. | Up to 28 days |
| Patient Global Impression (PGI) Severity and Change measures from Baseline to Day 8, Day 14, Day 21, and 28. | Measured by changes in participant rated Patient Global Impression. | Up to 28 days |
| Change in the area under the curve for Net Symptom Burden from Baseline to Day 8, Day 14, Day 21, and 28. | Summary measure integrating semi-daily serial assessments of a subject's symptom count and severity over the duration of the study. | Up to 28 days |
| Change in clinical status from Baseline to Day 8, Day 14, Day 21, and Day 28. | 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). | Up to 28 days |
| All-cause mortality rate at Day 28. | Rate of deceased participants at day 28. | 28 days |
| Proportion of subjects who have not returned to "normal" at the day 21 and day 28 visits. | Proportion of subjects who do not have a PGI-Severity or CGI-Severity assessment of "normal" at the day 21 and day 28 visits. | 28 days |
| Centro |
| Rio de Janeiro |
| 20020-000 |
| Brazil |
| IBPClin | Glória | Rio de Janeiro | 20241-180 | Brazil |
| Casa de Saúde | Campinas | Sau Paulo | 14.784-400 | Brazil |
| IPECC | São Paulo | State of Sau Paulo | 13.060-080 | Brazil |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |