Clinical trial NCT04443868: Nitric Oxide Releasing Solution to Treat and Prevent Exacerbation of Mild COVID-19 Infection
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: SARS-CoV Infection
Lead sponsor: Sanotize Research and Development corp.
Sponsor class: INDUSTRY
First posted: 2020-06-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: To Measure the efficacy of NONI compared to saline placebo control to shorten the duration of COVID-19 viral infectivity
timeFrame: 6 Days
Secondary outcomes:
measure: To Measure the virucidal effect of NONI compared to placebo in the nasal cavity in subjects with mild COVID-19 infection
timeFrame: 2, 4 and 6 days
measure: To Measure the virucidal effect of NONI compared to placebo in the nasal cavity in subjects with mild COVID-19 infection
timeFrame: 2, 4 and 6 days
measure: To Measure the efficacy of NONI in prevention of progression of COVID-19
timeFrame: 28 days
measure: To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life (QoL) in subjects with COVID-19
timeFrame: 6 days
measure: To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life in subjects with COVID-19
timeFrame: 2, 4, 6, 14 and 28 days
measure: To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life in subjects with COVID-19
timeFrame: 2, 4, 6, 14 and 28 days
measure: To measure the tolerance of NONI compared to saline placebo in participants with mild COVID-19 infection
timeFrame: 14 days
measure: To measure the tolerance of NONI compared to saline placebo in participants with mild COVID-19 infection
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
affiliation: Richmond ENT
name: Mike armstrong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SaNOtize Scientific Advisor
name: Chris Miller, Ph.D
role: STUDY_DIRECTOR
References: