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Study of ZnAg Liquid Solution to Treat COVID-19 Symptomatic Participants

Primary Purpose

Covid19

Status

Completed

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

CNM-ZnAg

Placebo

About this trial

This is an interventional treatment trial for Covid19 focused on measuring SARS-CoV-2, COVID, COVID-19, Corona Virus

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adults, aged 40 - 90 years (inclusive)
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.
Laboratory-confirmed SARS-CoV-2 infection as determined by positive PCR in a sample collected ≤ 96 hours prior to the Baseline visit.
PGI-Severity and CGI-Severity assessments of 'Mild', 'Moderate, or 'Severe' at the Screening visit (e.g., cannot be 'Normal').
Participant (or legally authorized representatives) provides informed consent prior to the initiation of any study procedures.
Participant is willing and able to follow all study procedures and assessments according to the study protocol.
Participant is able to consume 60 ml of fluid orally twice daily.
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:

Unable or unwilling to take ZnAg liquid solution or matching placebo as directed.
Hospitalized prior to Baseline for COVID-19 management.
Need for hospitalization and/or ventilatory support at Baseline.
The emergence of any disease during study, other than COVID-19 that could better explain the participants' signs and symptoms.
Severe disease: respiratory distress, or requiring supplemental oxygen, or SpO2 ≤ 93% on room air, or tachypnea (respiratory rate ≥ 30 breaths/min) at Baseline.
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).
Legal incapacity or limited legal capacity.
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.
Pregnant or breastfeeding.
Participation in another clinical study with an investigational product within the prior 12 months (per Resolution 251/1997).

Sites / Locations

PROCAPE
Projeto Praca Onze
IBPClin
Casa de Saúde
IPECC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Active treatment with 60 ml low-dose ZnAg

Active treatment with 60 ml high-dose ZnAg

60 ml matching placebo

Arm Description

(Zn 6 ug/ml and Ag 10 ug/ml; equivalent to 0.6 mg Ag, 0.36 mg Zn), po q12 hours

(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

Outcomes

Primary Outcome Measures

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'.

Secondary Outcome Measures

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).

Proportion of participants who are hospitalized, requires hospitalization or are deceased.

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.

Full Information

NCT ID

NCT04610138

First Posted

October 28, 2020

Last Updated

March 30, 2023

Sponsor

Clene Nanomedicine

Collaborators

ICL Pharma, Azidus Brazil

1. Study Identification

Unique Protocol Identification Number

NCT04610138

Brief Title

Study of ZnAg Liquid Solution to Treat COVID-19 Symptomatic Participants

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

June 1, 2021 (Actual)

Primary Completion Date

May 28, 2022 (Actual)

Study Completion Date

October 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Clene Nanomedicine

Collaborators

ICL Pharma, Azidus Brazil

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

SARS-CoV-2, COVID, COVID-19, Corona Virus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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

ParticipantCare ProviderInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

296 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active treatment with 60 ml low-dose ZnAg

Arm Type

Experimental

Arm Description

(Zn 6 ug/ml and Ag 10 ug/ml; equivalent to 0.6 mg Ag, 0.36 mg Zn), po q12 hours

Arm Title

Active treatment with 60 ml high-dose ZnAg

Arm Type

Experimental

Arm Description

(Zn 12 ug/ml and Ag 20 ug/ml; equivalent to 1.2 mg Ag, 0.72 mg Zn), po q12 hours;

Arm Title

60 ml matching placebo

Arm Type

Placebo Comparator

Arm Description

60 ml matching placebo, po q12 hours

Intervention Type

Drug

Intervention Name(s)

CNM-ZnAg

Intervention Description

ZnAg liquid solution

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Water

Primary Outcome Measure Information:

Title

Time to substantial alleviation of COVID-19 symptoms.

Description

Time Frame

Up to 28 days.

Secondary Outcome Measure Information:

Title

Time to complete alleviation of COVID-19 symptoms.

Description

Time to complete alleviation of COVID-19 symptoms up to 28- days, over a continuous period ≥ 48 hours (confirmed symptom resolution).

Time Frame

Up to 28 days.

Title

Proportion of participants who are hospitalized, requires hospitalization or are deceased.

Description

Time Frame

Up to 28 days

Other Pre-specified Outcome Measures:

Title

Number of alive hospital free days at Day 28.

Description

Days from baseline participant remains alive.

Time Frame

28 days

Title

Mean change from Baseline to Day 8, Day 14, Day 21, and Day 28 in SARS-CoV-2 viral load.

Description

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.

Time Frame

Up to 28 days

Title

Change from Baseline to Day 8, Day 14, Day 21, and 28 in the slope of oxygen saturation levels (SpO2) assessed per protocol.

Description

Oxygen saturation will be obtained after the participant has been resting for 5 minutes.

Time Frame

up to 28 days

Title

Clinical Global Impression (CGI) Severity and Change measures from Baseline to Day 8, Day 14, Day 21, and 28.

Description

Measured by changes in participant rated Clinical Global Impression.

Time Frame

Up to 28 days

Title

Patient Global Impression (PGI) Severity and Change measures from Baseline to Day 8, Day 14, Day 21, and 28.

Description

Measured by changes in participant rated Patient Global Impression.

Time Frame

Up to 28 days

Title

Change in the area under the curve for Net Symptom Burden from Baseline to Day 8, Day 14, Day 21, and 28.

Description

Summary measure integrating semi-daily serial assessments of a subject's symptom count and severity over the duration of the study.

Time Frame

Up to 28 days

Title

Change in clinical status from Baseline to Day 8, Day 14, Day 21, and Day 28.

Description

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).

Time Frame

Up to 28 days

Title

All-cause mortality rate at Day 28.

Description

Rate of deceased participants at day 28.

Time Frame

28 days

Title

Proportion of subjects who have not returned to "normal" at the day 21 and day 28 visits.

Description

Proportion of subjects who do not have a PGI-Severity or CGI-Severity assessment of "normal" at the day 21 and day 28 visits.

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults, aged 40 - 90 years (inclusive) 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. Laboratory-confirmed SARS-CoV-2 infection as determined by positive PCR in a sample collected ≤ 96 hours prior to the Baseline visit. PGI-Severity and CGI-Severity assessments of 'Mild', 'Moderate, or 'Severe' at the Screening visit (e.g., cannot be 'Normal'). Participant (or legally authorized representatives) provides informed consent prior to the initiation of any study procedures. Participant is willing and able to follow all study procedures and assessments according to the study protocol. Participant is able to consume 60 ml of fluid orally twice daily. 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: Unable or unwilling to take ZnAg liquid solution or matching placebo as directed. Hospitalized prior to Baseline for COVID-19 management. Need for hospitalization and/or ventilatory support at Baseline. The emergence of any disease during study, other than COVID-19 that could better explain the participants' signs and symptoms. Severe disease: respiratory distress, or requiring supplemental oxygen, or SpO2 ≤ 93% on room air, or tachypnea (respiratory rate ≥ 30 breaths/min) at Baseline. 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). Legal incapacity or limited legal capacity. 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. Pregnant or breastfeeding. Participation in another clinical study with an investigational product within the prior 12 months (per Resolution 251/1997).

Facility Information:

Facility Name

PROCAPE

City

Santo Amaro

State/Province

Recife

ZIP/Postal Code

89020-430

Country

Brazil

Facility Name

Projeto Praca Onze

City

Centro

State/Province

Rio De Janeiro

ZIP/Postal Code

20020-000

Country

Brazil

Facility Name

IBPClin

City

Gloria

State/Province

Rio De Janeiro

ZIP/Postal Code

20241-180

Country

Brazil

Facility Name

Casa de Saúde

City

Campinas

State/Province

Sau Paulo

ZIP/Postal Code

14.784-400

Country

Brazil

Facility Name

IPECC

City

Sao Paulo

State/Province

State Of Sau Paulo

ZIP/Postal Code

13.060-080

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study of ZnAg Liquid Solution to Treat COVID-19 Symptomatic Participants

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