- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04443868
Nitric Oxide Releasing Solution to Treat and Prevent Exacerbation of Mild COVID-19 Infection
Double-Blinded, Placebo-Controlled Parallel, Phase II Clinical Efficacy Study Evaluating NORS To Treat and Prevent the Exacerbation of Infection in Individuals With Documented Mild COVID-19
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Up to 50 subjects will be enrolled into one of two cohorts of this study in a ratio of 1:1 (Treatment: Placebo Control). Subjects will be screened and randomized into one of two parallel cohorts.
- Treatment (N = up to 25): Subjects will be enrolled and receive daily NONI treatment for 14 days with a follow-up visit on Day 28 post randomization.
- Placebo (N = up to 25): Subjects will be enrolled and receive a placebo for 14 days with a follow-up visit on Day 28 post randomization.
Study Type
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Capable of understanding and providing signed informed consent and ability to adhere to the requirements and restrictions of this protocol;
- Men and Women ≥ 18years of age;
- Internet access and capability and willingness to use to participate in audio or audio/video engagements with medical professionals, receive texts, emails, and phone calls from study staff and have a device and reasonable cellular data or other internet access to submit daily study required information using a smart phone, tablet, laptop, or desktop computer during the study period;
- COVID-19 infection confirmed with a laboratory antigen or SARS-CoV-2 RT-PCR nasal swab;
- Specimen collected within the past 48 hours;
- Mild COVID /FLU symptoms which may include no symptoms, fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, lack of taste or smell without shortness of breath or dyspnea;
Must be willing to use one highly effective birth control method which include: abstinence, hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy and tubal ligation or to use two forms of effective birth control methods which include: barrier methods of contraception (e.g. male condom, female condom, cervical cap, diaphragm, contraceptive sponge);
- Hormonal methods and the IUD must be in use at least 30 days prior to first Study drug administration
- Abstinence and barrier methods must be in use at least 14 days prior to Study drug administration
- Vasectomy must be completed 3 months prior to first Study drug administration; or in the alternative that a 0 sperm count will suffice.
Exclusion Criteria:
- Current tracheostomy or laryngectomy;
- Concomitant respiratory therapy such as oxygen or ventilatory support. Positive airway pressure for obstructive sleep apnea is permitted if treatment was established with good compliance at least 3 months before enrolment;
- Need for hospitalization for any reason;
- Inability to safely self-administer nasal irrigation
- Any clinical contraindications, as judged by the Qualified Medical Practitioner;
- Clinical signs indicative of moderate, severe or critical COVID severity symptoms (as defined by FDA COVID-19 Guidance Document)
- Mentally or neurologically disabled patients who are considered not fit to consent to their participation in the study;
- Lactating, pregnant or planning to become pregnant during the study period;
- Diagnosed with prior COVID-19 infection (>48 hours from the time the test is reported prior to the time of screening).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Nitric Oxide Releasing Solution
Daily nasal irrigation (240mL) 14.4ppm
|
Nasal Spray + Nasal Irrigation
Other Names:
|
PLACEBO_COMPARATOR: Placebo Isotonic Saline
Daily nasal irrigation (240mL) 0.9% saline
|
Nasal Spray + Nasal Irrigation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To Measure the efficacy of NONI compared to saline placebo control to shorten the duration of COVID-19 viral infectivity
Time Frame: 6 Days
|
Measure the SARS-CoV-2 viral load (Cycle threshold) at baseline through Day 6 between NONI and control arms.
|
6 Days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To Measure the virucidal effect of NONI compared to placebo in the nasal cavity in subjects with mild COVID-19 infection
Time Frame: 2, 4 and 6 days
|
Measure the proportion of subjects reaching Ct threshold (ie: unmeasurable viral load) between NONI and control
|
2, 4 and 6 days
|
To Measure the virucidal effect of NONI compared to placebo in the nasal cavity in subjects with mild COVID-19 infection
Time Frame: 2, 4 and 6 days
|
Measure the difference in time-to Ct threshold (ie: unmeasurable viral load) between NONI and control.
|
2, 4 and 6 days
|
To Measure the efficacy of NONI in prevention of progression of COVID-19
Time Frame: 28 days
|
Measure the proportion of subjects requiring hospitalization or ER/ED visits for COVID-19/flu-like symptoms
|
28 days
|
To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life (QoL) in subjects with COVID-19
Time Frame: 6 days
|
Measure the difference in 12-point COVID Symptom PROs score 0-3 (min 0 & max 36) and a QoL score from 0-100 (lower is worse) from baseline between NONI and control arms.
|
6 days
|
To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life in subjects with COVID-19
Time Frame: 2, 4, 6, 14 and 28 days
|
Measure the difference in proportion of subjects experiencing a reduction of ≥ 5 from baseline between NONI and control arms.
|
2, 4, 6, 14 and 28 days
|
To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life in subjects with COVID-19
Time Frame: 2, 4, 6, 14 and 28 days
|
Measure the difference in proportion of subjects with reduction to a score of zero from baseline between NONI and control arms.
|
2, 4, 6, 14 and 28 days
|
To measure the tolerance of NONI compared to saline placebo in participants with mild COVID-19 infection
Time Frame: 14 days
|
Number of participants lost-to-follow-up,discontinuing study treatment or number of treatments due to intolerance
|
14 days
|
To measure the tolerance of NONI compared to saline placebo in participants with mild COVID-19 infection
Time Frame: 14 days
|
Severity and frequency of adverse events, pain, discomfort or discontinuations of treatment.
|
14 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mike armstrong, MD, Richmond ENT
- Study Director: Chris Miller, Ph.D, SaNOtize Scientific Advisor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Disease Attributes
- Severe Acute Respiratory Syndrome
- Infections
- Communicable Diseases
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Antioxidants
- Free Radical Scavengers
- Endothelium-Dependent Relaxing Factors
- Gasotransmitters
- Nitric Oxide
Other Study ID Numbers
- COVID-IND-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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