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

NCT04443868 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: COVID-IND-02
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

SARS-CoV Infection

Outcome Measures

Primary Outcomes (1)

• To Measure the efficacy of NONI compared to saline placebo control to shorten the duration of COVID-19 viral infectivity

  Measure the SARS-CoV-2 viral load (Cycle threshold) at baseline through Day 6 between NONI and control arms.

  6 Days

Secondary Outcomes (8)

• To Measure the virucidal effect of NONI compared to placebo in the nasal cavity in subjects with mild COVID-19 infection

  2, 4 and 6 days

• To Measure the virucidal effect of NONI compared to placebo in the nasal cavity in subjects with mild COVID-19 infection

  2, 4 and 6 days

• To Measure the efficacy of NONI in prevention of progression of COVID-19

  28 days

• To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life (QoL) in subjects with COVID-19

  6 days

• To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life in subjects with COVID-19

  2, 4, 6, 14 and 28 days

Study Arms (2)

Nitric Oxide Releasing Solution

EXPERIMENTAL

Daily nasal irrigation (240mL) 14.4ppm

Drug: Nitric Oxide-Releasing Drug

Placebo Isotonic Saline

PLACEBO COMPARATOR

Daily nasal irrigation (240mL) 0.9% saline

Drug: Nitric Oxide-Releasing Drug

Interventions

Nitric Oxide-Releasing Drug DRUG

Nasal Spray + Nasal Irrigation

Also known as: nitric oxide

Nitric Oxide Releasing Solution; Placebo Isotonic Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable of understanding and providing signed informed consent and ability to adhere to the requirements and restrictions of this protocol;
• Men and Women ≥ 18years of age;
• Internet access and capability and willingness to use to participate in audio or audio/video engagements with medical professionals, receive texts, emails, and phone calls from study staff and have a device and reasonable cellular data or other internet access to submit daily study required information using a smart phone, tablet, laptop, or desktop computer during the study period;
• COVID-19 infection confirmed with a laboratory antigen or SARS-CoV-2 RT-PCR nasal swab;
• Specimen collected within the past 48 hours;
• Mild COVID /FLU symptoms which may include no symptoms, fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, lack of taste or smell without shortness of breath or dyspnea;
• Must be willing to use one highly effective birth control method which include: abstinence, hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy and tubal ligation or to use two forms of effective birth control methods which include: barrier methods of contraception (e.g. male condom, female condom, cervical cap, diaphragm, contraceptive sponge);
• Hormonal methods and the IUD must be in use at least 30 days prior to first Study drug administration
• Abstinence and barrier methods must be in use at least 14 days prior to Study drug administration
• Vasectomy must be completed 3 months prior to first Study drug administration; or in the alternative that a 0 sperm count will suffice.

You may not qualify if:

• Current tracheostomy or laryngectomy;
• Concomitant respiratory therapy such as oxygen or ventilatory support. Positive airway pressure for obstructive sleep apnea is permitted if treatment was established with good compliance at least 3 months before enrolment;
• Need for hospitalization for any reason;
• Inability to safely self-administer nasal irrigation
• Any clinical contraindications, as judged by the Qualified Medical Practitioner;
• Clinical signs indicative of moderate, severe or critical COVID severity symptoms (as defined by FDA COVID-19 Guidance Document)
• Mentally or neurologically disabled patients who are considered not fit to consent to their participation in the study;
• Lactating, pregnant or planning to become pregnant during the study period;
• Diagnosed with prior COVID-19 infection (\>48 hours from the time the test is reported prior to the time of screening).

Sponsors & Collaborators

• Sanotize Research and Development corp.: lead

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals

Study Officials

• Mike armstrong, MD

  Richmond ENT

  PRINCIPAL INVESTIGATOR

• Chris Miller, Ph.D

  SaNOtize Scientific Advisor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2020
• First Posted: June 23, 2020
• Study Start: January 1, 2021
• Primary Completion: April 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 16, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share