NCT04443868

Nitric Oxide Releasing Solution to Treat and Prevent Exacerbation of Mild COVID-19 Infection

Double-Blinded, Placebo-Controlled Parallel, Phase II Clinical Efficacy Study Evaluating NORS To Treat and Prevent the Exacerbation of Infection in Individuals With Documented Mild COVID-19

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sanotize Research and Development corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blinded, placebo-controlled parallel, phase II clinical efficacy study evaluating Nitric Oxide Nasal Irrigation (NONI) for the treatment of COVID-19 in individuals with mild COVID-19 Infection.

Detailed description

Up to 50 subjects will be enrolled into one of two cohorts of this study in a ratio of 1:1 (Treatment: Placebo Control). Subjects will be screened and randomized into one of two parallel cohorts. * Treatment (N = up to 25): Subjects will be enrolled and receive daily NONI treatment for 14 days with a follow-up visit on Day 28 post randomization. * Placebo (N = up to 25): Subjects will be enrolled and receive a placebo for 14 days with a follow-up visit on Day 28 post randomization.

Conditions

• SARS-CoV Infection

Interventions

Type	Name	Description
DRUG	Nitric Oxide-Releasing Drug	Nasal Spray + Nasal Irrigation

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-04-01
• Completion: 2021-07-01
• First posted: 2020-06-23
• Last updated: 2021-07-16

Regulatory

• FDA-regulated drug study