What is the efficacy and safety of nitric oxide nasal spray (NONS) in the prevention of coronavirus disease-19 (COVID-19) infection when compared to placebo in healthy adult volunteers?

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

The study settings include, National Institute of Infectious Diseases (IDH), Angoda, Colombo North Teaching Hospital, Ragama, Puttalam Base Hospital, Puttalam, Peradeniya Teaching Hospital, Peradeniya, Karapitiya Teaching Hospital, Galle, Negombo District General Hospital, Negombo

Participants aged 18 or over with no known history of SARS-CoV-2 infection or previous vaccination against SARS-CoV-2 will be enrolled into one of two cohorts of this study in a ratio of 1:1 (Treatment: Placebo Control). Participants with or without underlying medical conditions will be eligible to enrol.

Participants will self-administer a nasal spray three (3) times per day, morning, noon, and night containing either blinded study treatment or placebo (herein called study treatment). With the support of healthcare professionals in identified MoH divisions, site teams will be contacting eligible individuals for voluntary participation. Nitric oxide nasal spray will be delivered from manual pump nasal spray bottle containing 25 mL of solution with each nasal spray dispensing approximately 130-150 microliters of solution. Each treatment will require two sprays per nostril (1 spray per nostril, repeated once), or about 0.56 mL per treatment (4 sprays total per dose).

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.

Sodium chloride will be used as the placebo for this trial. A sodium chloride wash is a known product used to manage viral infections.

The sponsor has designed a dual chamber nasal spray bottle for nitric oxide releasing solution (NORS) administration. The same bottle will be filled with normal saline before being provided to the participant.

1. At least aged 18 years old at the time of consent (/males and females).
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 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 intrauterine device (IUD), intrauterine system (IUS), transdermal hormonal implant, vaginal hormonal ring, or two 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 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 a telephone, the internet, a device that reliability connects to the internet, and 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), unless in a region (EU) or other location where the participant must receive the study product directly from the sites’ staff/physician.

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.
3. Participants with any prior history of SARS-CoV-2 infection.
4. Participants who have received any dose of SARS-CoV-2 vaccine.
5. Participants who use intranasally dosed drugs, prescriptions or over-the-counter medications such as fluticasone within the last 7 days.
6. Participants who underwent a previous tracheostomy.
7. Participants who are receiving any form of oxygen therapy.
8. Females who are breastfeeding, pregnant, or attempting to become pregnant.
9. 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 who are mentally or neurologically disabled and who 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.