Nitric Oxide Releasing Solution to Treat and Prevent Exacerbation of Mild COVID-19 Infection

July 12, 2021 updated by: Sanotize Research and Development corp.

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

This is a double-blinded, placebo-controlled parallel, phase II clinical efficacy study evaluating Nitric Oxide Nasal Irrigation (NONI) for the treatment of COVID-19 in individuals with mild COVID-19 Infection.

Study Overview

Status

Withdrawn

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

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • nitric oxide
PLACEBO_COMPARATOR: Placebo Isotonic Saline
Daily nasal irrigation (240mL) 0.9% saline
Nasal Spray + Nasal Irrigation
Other Names:
  • nitric oxide

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mike armstrong, MD, Richmond ENT
  • Study Director: Chris Miller, Ph.D, SaNOtize Scientific Advisor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2021

Primary Completion (ANTICIPATED)

April 1, 2021

Study Completion (ANTICIPATED)

July 1, 2021

Study Registration Dates

First Submitted

June 20, 2020

First Submitted That Met QC Criteria

June 20, 2020

First Posted (ACTUAL)

June 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 16, 2021

Last Update Submitted That Met QC Criteria

July 12, 2021

Last Verified

July 1, 2021

More Information

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.

Clinical Trials on SARS-CoV Infection

Clinical Trials on Nitric Oxide-Releasing Drug

3
Subscribe