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

• Status: Not yet recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

Summary

A decentralized, 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sanotize Research and Development corp.
• Treatments: Nitric Oxide

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 child-bearing potential, must be using an acceptable method of contraception (other than a combination estrogen/progestin hormonal contraceptive) for at least 1 month prior to Day 1, such as an intrauterine device (IUD), implant, or two forms of the following: diaphragm, cervical cap, patch, condom, spermicide, or sponge. In addition, females of child-bearing 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. Must have access to the internet and a device that reliability connects to the internet and is able to dial into Telehealth checkups and study related assessments.

7. Must be able to receive study product shipments directly to their home (ie, no Post Office Boxes).

Exclusion Criteria:

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

1. Participants with any respiratory infection, flu-like symptoms, or unexplained fever or chills during the week prior to Screening.

2. Participants with any prior history of SARS-CoV-2 infection.

3. Participants who have received any dose of SARS-CoV-2 vaccine.

4. Participants who use intranasally dosed drugs, prescriptions or over-the-counter medications such as fluticasone.

5. Participants who underwent a previous tracheostomy.

6. Participants who are receiving concomitant treatment of respiratory support (involving 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.