Participants COVID-19 negative at baseline will be randomized to receive standard COVID-19 screening and protection (per their facility or organization's protocols).

Participants COVID-19 negative at baseline will be randomized to receive standard COVID-19 screening and protection (per their facility or organization's protocols) plus daily NORS treatment for 14 days.

Volunteers who are found to be COVID-19 positive during screening will be eligible to enroll in the 21-day Treatment sub-study and receive daily NORS treatment for 14 days. Ten participants can be directly enrolled in the Treatment sub-study.
Participants enrolled in the Prevention study who meet the criteria in this section will roll over into the Treatment Sub-Study but must remain in their randomly assigned group.

Corona Virus Infection

NORS treatment will consist of daily self-administration of three routes; Nitric Oxide Gargle (NOG) every morning, Nitric Oxide Nasophyaryngeal Irrigation (NONI) every evening, and Nitric Oxide Nasal Spray (NONS) up to 5 times per day.

NORS (Nitric Oxide Releasing Solution)

Up to ten volunteers who are found to be COVID-19 positive during screening will be eligible to enroll in the 21-day Treatment sub-study and receive daily NORS treatment for 14 days. NORS treatment will consist of daily self-administration of three routes; Nitric Oxide Gargle (NOG) every morning, Nitric Oxide Nasophyaryngeal Irrigation (NONI) every evening, and Nitric Oxide Nasal Spray (NONS) up to 5 times per day.
Any participants enrolled in the Prevention study who meet the criteria for the sub study will roll over into the Treatment Sub-Study but must remain in their randomly assigned group.

BC Diabetes

LMC Manna

Diex Recherche Québec

Diex Recherche Joliette

Diex Recherche Sherbrooke

Nitric Oxide Releasing Solutions to Prevent and Treat Mild/Moderate COVID-19 Infection

Multi-Center, Randomized, Controlled, Phase II Clinical Efficacy Study Evaluating Nitric Oxide Releasing Solution Treatment for the Prevention and Treatment of COVID-19 in Healthcare Workers and Individuals at Risk of Infection

Measure the proportion of subjects with either swab positive COVID-19 or presentation of clinical symptoms as measured by fatigue with either fever >37.2 (oral)and/or a persistent cough.

Measure the proportion of participants requiring requiring hospitalization for COVID-19/flu-like symptoms and/or needing oxygen therapy, BIPAP/CPAP, intubation and mechanical ventilation following enrollment.

Measure the tolerability of the NORS treatments as determined by number of adverse events, pain, discomfort or discontinuations of treatment.

Measure the median number of days to negative conversion of SARS-CoV-2 RT-PCR from a nasopharyngeal swabs.

Determine the time to clinical recovery in participants with COVID-19 by measuring the median number of days from enrollment to discharge (if admitted), or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air).

Measure the reduction clinical symptoms in participants with COVID- 19 by the magnitude of the change in Modified Jackson Cold Score Diary Score (5-unit change is a substantial clinical benefit).

Measure the proportion of participants that have a positive sero-conversion for SARS-CoV-2

Sanotize Research and Development corp.

The Emmes Company, LLC

Keyrus Life Science

Multi-center, prospective, randomized, controlled, phase II, parallel group

This study will be comprised of the following four time periods: "baseline", "run-in", "low FODMAP diet", and "high FODMAP diet". Participants will undergo baseline assessment with questionnaires on demographics, IBS symptoms (IBS symptom severity scoring questionnaire), diet, and psychological parameters. Baseline mucosal colonic biopsies will be obtained, and metabolome analysis from urine samples. These will be repeated 3 other times during each of the above time periods. Low FODMAP Diet followed by a High FODMAP Diet

Irritable Bowel Syndrome With Diarrhea

3 weeks on a low FODMAP diet followed by 3 weeks on a high FODMAP Diet

Low FODMAP Diet followed by a High FODMAP Diet

Effect of FODMAPs on Mucosal Inflammation in IBS Patients

A Study Evaluating the Effects of Low and High FODMAP Diets on Mucosal Protease Nerve Interactions in IBS Patients

Number of IBS patients whose supernatants increased neuronal excitability with high FODMAP vs. Low FODMAP diet ( excitability = rheobase = amount of current needed to elicit a single action potential) measured by patch clamp recording of mouse DRG neurons incubated in response to incubation with proteases in the IBS-D supernatants.

Number of patients whose symptoms improved with the low FODMAP diets using the IBS-SSS questionnaire

The number of patients whose HADS questionnaire worsened with a high FODMAP diet and/or improved with a low FODMAP diet

Number of patients whose 16S RNA profile changed following a low or high FODMAP diet.

Number of patients whose urine metabolome was altered by a low and high FODMAP diet.

Number of patients whose metabolome in blood was altered by a low and high FODMAP diet.

common cold/protease

Nitric Oxide Releasing Solutions to Prevent and Treat Mild/Moderate COVID-19 Infection

Effect of FODMAPs on Mucosal Inflammation in IBS Patients

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