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

NCT04610138 | Completed Phase 2

• 1 other identifier: CNMZnAg.202
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 5

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.

Conditions

Covid19

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• Time to complete alleviation of COVID-19 symptoms.

  Up to 28 days.

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

  Up to 28 days

Other Outcomes (9)

• Number of alive hospital free days at Day 28.

  28 days

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

  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.

  up to 28 days

Study Arms (3)

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

Drug: CNM-ZnAg

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;

Drug: CNM-ZnAg

60 ml matching placebo

PLACEBO COMPARATOR

60 ml matching placebo, po q12 hours

Drug: Placebo

Interventions

CNM-ZnAg DRUG

ZnAg liquid solution

Active treatment with 60 ml high-dose ZnAg; Active treatment with 60 ml low-dose ZnAg

Placebo DRUG

Water

60 ml matching placebo

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Clene Nanomedicine: lead
• ICL Pharma: collaborator
• Azidus Brazil: collaborator

Study Sites (5)

PROCAPE

Santo Amaro, Recife, 89020-430, Brazil

Location

Projeto Praca Onze

Centro, Rio de Janeiro, 20020-000, Brazil

Location

IBPClin

Glória, Rio de Janeiro, 20241-180, Brazil

Location

Casa de Saúde

Campinas, Sau Paulo, 14.784-400, Brazil

Location

IPECC

São Paulo, State of Sau Paulo, 13.060-080, Brazil

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: October 30, 2020
• Study Start: June 1, 2021
• Primary Completion: May 28, 2022
• Study Completion: October 20, 2022
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (5)