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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
Sponsor:
Collaborators:
ICL Pharma
Azidus Brazil
Information provided by (Responsible Party):
Clene Nanomedicine

Tracking Information
First Submitted Date  ICMJE October 28, 2020
First Posted Date  ICMJE October 30, 2020
Last Update Posted Date February 1, 2021
Estimated Study Start Date  ICMJE February 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2021)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 28, 2020)
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'.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2021)
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'.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2020)
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.
Current Other Pre-specified Outcome Measures
 (submitted: October 29, 2020)
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: October 28, 2020)
  • 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.
  • All-cause mortality rate at Day 28. [ Time Frame: 28 days ]
    Rate of deceased participants at day 28.
 
Descriptive Information
Brief Title  ICMJE Study of ZnAg Liquid Solution to Treat COVID-19 Symptomatic Participants
Official Title  ICMJE 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
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
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.
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE
  • Drug: CNM-ZnAg
    ZnAg liquid solution
  • Drug: Placebo
    Water
Study Arms  ICMJE
  • 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
    Intervention: Drug: CNM-ZnAg
  • 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;
    Intervention: Drug: CNM-ZnAg
  • Placebo Comparator: 60 ml matching placebo
    60 ml matching placebo, po q12 hours
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 27, 2021)
276
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2020)
238
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Renata Lourencini +55 (11) 9.9383-6275 renata.lourencini@iclpharma.com
Contact: Robert Glanzman, MD 801-676-9695 robert@clene.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04610138
Other Study ID Numbers  ICMJE CNMZnAg.202
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Clene Nanomedicine
Study Sponsor  ICMJE Clene Nanomedicine
Collaborators  ICMJE
  • ICL Pharma
  • Azidus Brazil
Investigators  ICMJE Not Provided
PRS Account Clene Nanomedicine
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP