Multicenter, randomized, double-blinded, placebo-controlled, phase 3clinical efficacy study evaluating nitric oxide nasal spray (NONS) as a prevention treatment for individuals at risk of exposure to COVID-19 infectio
- Conditions
- COVID-19
- Registration Number
- SLCTR/2021/034
- Lead Sponsor
- SaNOtize Research and Development Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy of NONS in the prevention of COVID-19 infection as determined by a positive COVID-19 test (antigen or reverse-transcriptase polymerase chain reaction [RT-PCR]). [Between Day 1 to Day 28]<br>
- Secondary Outcome Measures
Name Time Method Proportion of participants requiring hospitalization or emergency room (ER/emergency department [ED]) visits for COVID-19 or flu-like symptoms by Day 28 [From Day 1 to Day 28]<br>Safety/tolerability of the use of NONS in participants for the prevention of COVID-19 through the reported adverse events and discontinuation of treatment [ From Day 1 to Day 28]<br> []<br> []<br> []<br> []<br> []<br> []<br>