A multicenter, randomized, double-blinded, placebo-controlled, phase 3 clinical efficacystudy evaluating nitric oxide nasal spray (NONS) as prevention for treatment ofindividuals at risk of exposure to COVID-19 infection.
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]),
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
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
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.
Medical Trust Clinics , Inc
Oshawa, Ontario, Canada
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
Keith Moore, PHARMD, Study Director
Sanotize Research and Development corp.