Phase 3 Clinical Study Evaluating Nitric Oxide Nasal Spray (NONS) Efficacy To Treat and Prevent t… (NCT05012319) | Clinical Trial Compass
UnknownPhase 3
Phase 3 Clinical Study Evaluating Nitric Oxide Nasal Spray (NONS) Efficacy To Treat and Prevent the Exacerbation of Infection in Individuals With Documented Asymptomatic or Mild COVID-19
Bahrain500 participantsStarted 2021-08-05
Plain-language summary
Study Design: This is a double-blind, placebo-controlled, Phase 3 clinical efficacy study evaluating NONS in adult volunteers as a treatment for high-risk asymptomatic and symptomatic individuals with mild COVID-19 infection. thru facility).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Inclusion Criteria:
* 18 years and above.
* COVID-19 infection Confirmed with a laboratory SARS-CoV-2 RT-PCR nasal swab or antigen test. COVID-19 test specimen must be collected 48 hours prior to Screenings.
* Mild COVID-19 Infection defined as:
* No Pneumonia (negative by chest auscultation or Chest X Ray).
* No Shortness of breath.
* No Tachypnea (respiratory rate \<20 breathes/min)
* No Hypoxia (Oxygen saturation \>93% on RA)
* Fever \<38 degrees.
* No Chest Pain.
* No Mental Status Change.
* Asymptomatic participants must be high risk defined as (any of the following):
* Smokers (at least 5 cigarettes per day)
* BMI (\> 40 kg/m2)
* History of cardiac or chronic lung disease
* Clotting predisposing conditions (hemophilia, von Willebrand's disease)
* Sickle cell disease
* Immunocompromised such as HIV , cancer , on immunosuppressant medications
Exclusion Criteria:
* Participants diagnosed with another (non-COVID-19) respiratory infection.
* Participants with a current tracheostomy or laryngectomy.
* Participants who are receiving concomitant respiratory therapy such as oxygen, positive airway pressure or ventilatory support. NOTE: Positive airway pressure for obstructive sleep apnea is permitted if the treatment was established with good compliance for at least 3 months before study enrollment.
* Participants with newly diagnosed illnesses that are not deemed stable by the participant's primary care physician), based on I…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
efficacy of NONS compared to placebo in participants with COVID-19 to reduce the need of urgent care