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Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to 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: NCT05109611
Recruitment Status : Active, not recruiting
First Posted : November 5, 2021
Last Update Posted : November 8, 2022
Sponsor:
Information provided by (Responsible Party):
Sanotize Research and Development corp.

Brief Summary:
A multicenter, randomized, double-blinded, placebo-controlled, phase 3 clinical efficacy study evaluating nitric oxide nasal spray (NONS) as prevention for treatment of individuals at risk of exposure to COVID-19 infection.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Infection Drug: Nitric Oxide Device: Nasal spray with isotonic saline Phase 3

Detailed Description:

This is a multicenter, randomized, double-blinded, placebo-controlled, Phase 3 clinical efficacy study evaluating NONS in adult volunteers as a prevention treatment for individuals at risk from COVID-19 infection.

Up to 13 000 adult participants aged 18 or over with no known history of SARS-CoV-2 infection will be randomized into one of 2 cohorts of this study in a ratio of 1:1 (Treatment: Placebo Control). Participants with or without underlying medical conditions will be eligible to enroll. The NONS formulation proposed for use in this COVID-19 clinical study will be self-administered at a maximum of 3 times per day, morning, noon, and night for 28 days. Participants will be on study for 4 weeks of treatment (to include 5 days of Screening, 1 week of Follow-Up, participants will be followed for a total of approximately 5 weeks) as a viricidal Investigational Medical Product.

Participants will self-administer a nasal spray containing either blinded study treatment or placebo (herein called study treatment). Nitric oxide nasal spray will be delivered from manual pump nasal spray container with 25 mL of solution with each nasal spray dispensing approximately 130-150 µL of solution. After the participant blows their nose, each treatment will require 2 sprays per nostril, or about 0.5 mL per treatment.

The primary endpoint is to assess the efficacy of NONS in the prevention of symptomatic COVID-19 infection as determined by a positive COVID-19 test (antigen or reverse-transcriptase polymerase chain reaction [RT-PCR]),

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1389 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Identical labeled nasal spray bottles
Primary Purpose: Prevention
Official Title: A Multicenter, Randomized, Double-blinded, Placebo-controlled, Phase 3 Clinical Efficacy Study Evaluating Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection
Actual Study Start Date : November 20, 2021
Estimated Primary Completion Date : July 30, 2023
Estimated Study Completion Date : July 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nitric Oxide Releasing Solution

Nasal spray with nitric oxide releasing solution (NORS) delivered up to 3 times daily morning, mid-day, and evening.

Maximum volume delivered: 0.56 mL NORS @ 0.11ppm*hrs

Drug: Nitric Oxide
The Sponsor designed a dual chamber nasal spray bottle for NORS administration. Components are mixed from two chambers to create the final NO-producing formulation. The liquid contains NO at 0.11 ppm*hour, which acts as a viricidal agent. Instructions for storing, preparing, and administering the study treatment will be provided to participants.
Other Name: Nasal Spray

Placebo Comparator: Placebo

Nasal spray with isotonic saline delivered up to 3 times daily morning, mid-day, and evening.

Maximum volume delivered: 0.56 mL Saline @ 0.9%

Device: Nasal spray with isotonic saline
The Sponsor designed a dual chamber nasal spray bottle for NORS administration. The bottle will be filled with normal saline before being provided to the participant.
Other Name: Normal saline, 0.9% saline




Primary Outcome Measures :
  1. To assess the efficacy of NONS in the reduction of risk of COVID-19 infection. [ Time Frame: 28 days ]
    Confirmed positive COVID-19 test (Both antigen and SARS-CoV-2 RT-PCR acceptable) by Day 28.


Secondary Outcome Measures :
  1. To assess the efficacy of NONS in prevention of severe COVID-19. [ Time Frame: 28 days ]
    Hospitalization or ER/ED visits for COVID-19/flu-like symptoms by Day 28.

  2. Assess tolerability of NONS in participants with all participants including those with COVID-19. [ Time Frame: 28 days ]
    AEs and discontinuation 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:   Yes
Criteria

Inclusion Criteria Each participant must meet the following criteria to be enrolled in this study.

  1. At least aged 18 years old at the time of consent.
  2. If female, be surgically sterile or post-menopausal (no menses for at least 12 months), or if of childbearing potential, must be using an acceptable method of contraception such as a combination estrogen/progestin hormonal contraceptive (oral or injected) for at least 1 month prior to Day 1, or such items as an IUD, intrauterine system (IUS), transdermal hormonal implant, vaginal hormonal ring, or 2 forms of the following: diaphragm, cervical cap, patch, condom, spermicide, or sponge. Total abstinence is permitted. If local regulations deviate from the previously listed contraception methods to prevent pregnancy, local requirements will apply. In addition, females of childbearing potential must agree to continue to use their method of birth control for the duration of the study and 12 weeks following discharge from the study.
  3. If male, be surgically sterile, or agree to use appropriate contraception (latex condom with spermicide) when engaging in sexual activity and agree to not donate sperm for the duration of the study and 12 weeks following discharge from the study.
  4. Be in good health (ie, no acute illnesses or hospitalizations within 30 days of the study start, no planned procedures during study participation, and no newly diagnosed chronic illnesses that are not deemed stable by the participant's primary care physician), in the opinion of the Investigator, based on medical history (ie, absence of any clinically relevant abnormality) during Screening.
  5. Be able to understand and provide written, informed consent.
  6. Access to a telephone, the internet, a device that reliability connects to the internet, and able to dial into telehealth checkups and study-related assessments. If access to the internet precludes involvement, then paper diaries may be completed and promptly entered into the data capture system at the study centers as part of the regular follow-up visits.
  7. Must be able to receive study product shipments directly to their home (ie, no Post Office Boxes), unless in a region (EU) or other location where the participant must receive the study product directly from the sites' staff/physician.

Exclusion Criteria:

Participants who meet any of the following criteria will be excluded from the study.

  1. Participants with acute illnesses or hospitalizations within 30 days of the study start, and/or planned procedures during study participation, and/or newly diagnosed chronic illnesses that are not deemed stable by the participant's primary care physician), based on Investigator assessment of medical history during Screening.
  2. Participants with any respiratory infection, flu-like symptoms, or unexplained fever or chills during the week prior to Screening (see Section 6.6.2).
  3. Participants with any prior history of SARS-CoV-2 infection.
  4. Participants who use intranasally dosed drugs, prescriptions or over-the-counter medications such as fluticasone within the last 7 days.
  5. Participants who underwent a previous tracheostomy.
  6. Participants who are receiving any form of oxygen therapy.
  7. Females who are breastfeeding, pregnant, or attempting to become pregnant.
  8. Participants who have any other condition that, in the opinion of the Investigator, would interfere with a participant's ability to adhere to the protocol (eg, participants whom are mentally or neurologically disabled and whom are considered not fit to their participation in the study), interfere with assessment of the investigational product, or compromise the safety of the participant or the quality of the data.

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): NCT05109611


Locations
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Canada, Ontario
Medical Trust Clinics , Inc
Oshawa, Ontario, Canada, L1G 4T3
Sri Lanka
National Institute of Infectious Diseases Hospital, Angoda
Angoda, Sri Lanka
Karapitiya teaching Hospital,
Galle, Sri Lanka
Peradeniya Teaching Hospital,
Peradeniya, Sri Lanka
Puttalam Base Hospital,
Puttalam, Sri Lanka
Colombo North Teaching Hospital,
Ragama, Sri Lanka
Sponsors and Collaborators
Sanotize Research and Development corp.
Investigators
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Study Director: Keith Moore, PHARMD Sanotize Research and Development corp.
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Responsible Party: Sanotize Research and Development corp.
ClinicalTrials.gov Identifier: NCT05109611    
Other Study ID Numbers: COVID-NONS-04
First Posted: November 5, 2021    Key Record Dates
Last Update Posted: November 8, 2022
Last Verified: October 2022

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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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COVID-19
Nitric Oxide
Infections
Communicable Diseases
Disease Attributes
Pathologic Processes
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
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