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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04443868
Recruitment Status : Withdrawn (No subjects enrolled)
First Posted : June 23, 2020
Last Update Posted : July 16, 2021
Sponsor:
Information provided by (Responsible Party):
Sanotize Research and Development corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
SARS-CoV Infection Drug: Nitric Oxide-Releasing Drug Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nitric Oxide Releasing Solution
Daily nasal irrigation (240mL) 14.4ppm
Drug: Nitric Oxide-Releasing Drug
Nasal Spray + Nasal Irrigation
Other Name: nitric oxide

Placebo Comparator: Placebo Isotonic Saline
Daily nasal irrigation (240mL) 0.9% saline
Drug: Nitric Oxide-Releasing Drug
Nasal Spray + Nasal Irrigation
Other Name: nitric oxide




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04443868


Sponsors and Collaborators
Sanotize Research and Development corp.
Investigators
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Principal Investigator: Mike armstrong, MD Richmond ENT
Study Director: Chris Miller, Ph.D SaNOtize Scientific Advisor
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Responsible Party: Sanotize Research and Development corp.
ClinicalTrials.gov Identifier: NCT04443868    
Other Study ID Numbers: COVID-IND-02
First Posted: June 23, 2020    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Severe Acute Respiratory Syndrome
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents