Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection

Phase 3

Active, not recruiting

• Conditions: SARS-CoV-2 Infection
• Interventions: Device: Nasal spray with isotonic saline; Drug: Nitric Oxide

• Registration Number: NCT05109611
• Lead Sponsor: 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.

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 \[RT-PCR\]),

Study Timeline

• Study First Submitted: 2021-11-03
• Study First Submitted QC: 2021-11-03
• Study First Posted: 2021-11-05
• Study Start: 2021-11-20
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-06
• Primary Completion: 2024-01-30
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1389

Inclusion Criteria

Not provided

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Nasal spray with isotonic saline	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%
Nitric Oxide Releasing Solution	Nitric Oxide	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

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of NONS in the reduction of risk of COVID-19 infection.	28 days	Confirmed positive COVID-19 test (Both antigen and SARS-CoV-2 RT-PCR acceptable) by Day 28.

Secondary Outcome Measures

Name	Time	Method
To assess the efficacy of NONS in prevention of severe COVID-19.	28 days	Hospitalization or ER/ED visits for COVID-19/flu-like symptoms by Day 28.
Assess tolerability of NONS in participants with all participants including those with COVID-19.	28 days	AEs and discontinuation of treatment.

Trial Locations

Locations (6)

National Institute of Infectious Diseases Hospital, Angoda; 🇱🇰 Angoda, Sri Lanka

Puttalam Base Hospital,; 🇱🇰 Puttalam, Sri Lanka

Medical Trust Clinics , Inc; 🇨🇦 Oshawa, Ontario, Canada

Karapitiya teaching Hospital,; 🇱🇰 Galle, Sri Lanka

Peradeniya Teaching Hospital,; 🇱🇰 Peradeniya, Sri Lanka

Colombo North Teaching Hospital,; 🇱🇰 Ragama, Sri Lanka