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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04443868
Recruitment Status : Not yet recruiting
First Posted : June 23, 2020
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
Sanotize Research and Development corp.

Brief Summary:
This is a multi-center, double-blinded, placebo-controlled parallel, phase II clinical efficacy study evaluating NORS for the treatment of COVID-19 in individuals with Suspected mild COVID-19 Infection.

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

Detailed Description:

Up to 300 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 150): Subjects will be enrolled and receive daily NORS treatment for 14 days for the full duration with a follow-up visit on Day 28 post randomization.
  • Placebo (N = up to 150): Subjects will be enrolled and receive a placebo for 14 days for the full duration with a follow-up visit on Day 28 post randomization.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-Center, Double-Blinded, Placebo-Controlled, 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 : September 2020
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: NORS Drug: Nitric Oxide-Releasing Drug
Nasal Spray + Nasal Irrigation

Placebo Comparator: Placebo Drug: Nitric Oxide-Releasing Drug
Nasal Spray + Nasal Irrigation




Primary Outcome Measures :
  1. To Measure the efficacy of NORS compared to saline placebo in the hospitalization of participants with mild COVID-19 infection [ Time Frame: 28 Days ]
    Number of subjects requiring hospitalization or ER/ED visits for COVID-19/flu-like symptoms in NORS vs placebo group


Secondary Outcome Measures :
  1. To Measure reduction of clinical symptoms as compared to saline placebo in participants with mild COVID-19 infection [ Time Frame: 7, 14, 21 and 28 days ]
    Measure the change in mean Modified Jackson Cold Score Diary Score

  2. To measure the tolerance of NORS 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

  3. To measure the tolerance of NORS 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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;
  • English or French speaking;
  • Internet access and capability and willingness to use media venues to communicate during the study period;
  • COVID-19 infection confirmed with a laboratory SARS-CoV-2 RT-PCR nasal swab;
  • Specimen collected within the past 48 hours;
  • Mild or no COVID/FLU symptoms;
  • Must be willing to use one highly effective birth control method which include: 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; that barrier methods must be in use at least 14 days prior to Study drug administration; that 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 enrollment;
  • Need for hospitalization;
  • 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;
  • Pregnant;
  • 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


Contacts
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Contact: Chris Miller, Ph.D. 778-899-0607 chris@sanotize.com

Sponsors and Collaborators
Sanotize Research and Development corp.
Investigators
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Principal Investigator: Jeremy Road, MD SaNOtize Medical Advisor
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Responsible Party: Sanotize Research and Development corp.
ClinicalTrials.gov Identifier: NCT04443868    
Other Study ID Numbers: COVID-IND-01
First Posted: June 23, 2020    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
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