CompletedPhase 3

Nitric Oxide Nasal Spray (NONS) To Treat and Prevent the Exacerbation of Infection in Individuals With Mild COVID-19

India306 participantsStarted 2021-11-01

Plain-language summary

Primary: The primary objective of this study is to evaluate the efficacy of Nitric Oxide Nasal Spray combined with standard supportive care compared with standard supportive care alone in adult subjects with COVID-19 not requiring hospitalization Secondary: The secondary objective is to evaluate the safety and tolerability of Nitric Oxide Nasal Spray combined with standard supportive care compared with standard supportive care alone in adult subjects with COVID-19 not requiring hospitalization.

Who can participate

Age range

18 Years – 65 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

. Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures
. Age 18-65 years (inclusive) at the time of signing ICF
. Patients with laboratory confirmation of infection with SARS-CoV-2 by positive Rapid Antigen Test for SARS-CoV-2 at screening.
. Recent onset (within 48 hours of time of consent) symptoms of mild COVID-19 with oxygen saturation (SpO2 \> 94 %) and respiratory rate \< 24 breaths/min. Any of the COVID-19 like symptoms including fever, cough, sore throat, malaise, headache, nasal congestion, muscle pain, gastrointestinal symptoms, lack of taste or smell without shortness of breath or dyspnea; (the maximum permitted difference in the time of onset of symptoms and the time of consent is 48 hours)
. For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pretreatment urine pregnancy test

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

The primary objective of this study is to evaluate the efficacy of Nitric Oxide Nasal Spray combined with standard supportive care compared with standard supportive care alone in adult subjects with COVID-19 not requiring hospitalization

Timeframe: 8 days

Trial details

NCT IDNCT05599919

SponsorSanotize Research and Development corp.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-01-31

View on ClinicalTrials.gov More SARS-CoV-2 Infection trials

Plain-language summary

Who can participate

Age range

18 Years – 65 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

. Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures
. Age 18-65 years (inclusive) at the time of signing ICF
. Patients with laboratory confirmation of infection with SARS-CoV-2 by positive Rapid Antigen Test for SARS-CoV-2 at screening.
. Recent onset (within 48 hours of time of consent) symptoms of mild COVID-19 with oxygen saturation (SpO2 \> 94 %) and respiratory rate \< 24 breaths/min. Any of the COVID-19 like symptoms including fever, cough, sore throat, malaise, headache, nasal congestion, muscle pain, gastrointestinal symptoms, lack of taste or smell without shortness of breath or dyspnea; (the maximum permitted difference in the time of onset of symptoms and the time of consent is 48 hours)
. For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pretreatment urine pregnancy test

Nitric Oxide Nasal Spray (NONS) To Treat and Prevent the Exacerbation of Infection in Individuals With Mild COVID-19

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Nitric Oxide Nasal Spray (NONS) To Treat and Prevent the Exacerbation of Infection in Individuals With Mild COVID-19

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria