Home » Trials » SLCTR/2021/034


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

-

SLCTR Registration Number

SLCTR/2021/034


Date of Registration

25 Nov 2021

The date of last modification

Nov 25, 2021



Application Summary


Scientific Title of Trial

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


Public Title of Trial

Multicenter, randomized, double-blinded, placebo-controlled, phase 3 clinical efficacy study evaluating nitric oxide nasal spray (NONS) as a prevention treatment for individuals at risk of exposure to COVID-19 infection


Disease or Health Condition(s) Studied

COVID-19


Scientific Acronym

COVID-NONS-04


Public Acronym

COVID-NONS-04


Brief title

None


Universal Trial Number

U1111-1271-6893


Any other number(s) assigned to the trial and issuing authority

P/134/09/2021:ERC FoM, UoK, NCT05109611: ClinicalTrials.gov


Trial Details


What is the research question being addressed?

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?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded : Participants, Investigators, Healthcare providers, Outcome assessors


Control

Placebo


Assignment

Parallel


Purpose

Prevention


Study Phase

Phase 3


Intervention(s) planned

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.


Inclusion criteria

  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.

Exclusion criteria

  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.


Primary outcome(s)

1.

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

]

Secondary outcome(s)

1.

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

]
2.

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

]
3.
[]
4.
[]
5.
[]
6.
[]
7.
[]
8.
[]

Target number/sample size

3000 (1500 in a group)


Countries of recruitment

Sri Lanka


Anticipated start date

2021-11-25


Anticipated end date

2022-11-24


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

SaNOtize Research and Development Corporation


Regulatory approvals

Pending



State of Ethics Review Approval


Status

Approved


Date of Approval

2021-10-12


Approval number

P/134/09/2021


Details of Ethics Review Committee

Name: Faculty of Medicine, University of Kelaniya
Institutional Address:Faculty of Medicine, University of Kelaniya, P.O Box 6, Thalagolla Road, Ragama, Sri Lanka.
Telephone:+94 11 2961267
Email: ercmed@kln.ac.lk

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. Ananda Wijewickrama
Consultant Physician
National Institute of Infectious Diseases, Angoda – 10620, Sri Lanka
0112411224
+94777559398

anandawijewickrama012@gmail.com

Contact Person for Public Queries

Dr. Ananda Wijewickrama
Consultant Physician
National Institute of Infectious Diseases, Angoda – 10620, Sri Lanka
0112411224
+94777559398

anandawijewickrama012@gmail.com


Primary study sponsor/organization

SaNOtize Research and Development Corporation

SaNOtize Research and Development Corporation Suite 1 8755 Ash street Vancouver, British Columbia Canada V6P-6T3


chris@sanotize.com

Secondary study sponsor (If any)







Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

No


IPD sharing plan description

N/A


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results