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

NCT ID: NCT04443868

Last Updated: 2021-07-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-31
• Study Completion Date: 2021-07-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Nitric Oxide Releasing Solution

Daily nasal irrigation (240mL) 14.4ppm

Group Type: EXPERIMENTAL

Nitric Oxide-Releasing Drug

Intervention Type: DRUG

Nasal Spray + Nasal Irrigation

Placebo Isotonic Saline

Daily nasal irrigation (240mL) 0.9% saline

Group Type: PLACEBO_COMPARATOR

Nitric Oxide-Releasing Drug

Intervention Type: DRUG

Nasal Spray + Nasal Irrigation

Interventions

Nitric Oxide-Releasing Drug

Nasal Spray + Nasal Irrigation

Intervention Type: DRUG

Other Intervention Names

nitric oxide

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanotize Research and Development corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mike armstrong, MD

Role: PRINCIPAL_INVESTIGATOR

Richmond ENT

Chris Miller, Ph.D

Role: STUDY_DIRECTOR

SaNOtize Scientific Advisor

Other Identifiers

COVID-IND-02

Identifier Type: -

Identifier Source: org_study_id