SARS-CoV Infection
Conditions
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.
Interventions
DRUGNitric Oxide-Releasing Drug
Nasal Spray + Nasal Irrigation
Sponsors
Sanotize Research and Development corp.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Measure the efficacy of NONI compared to saline placebo control to shorten the duration of COVID-19 viral infectivity | 6 Days | Measure the SARS-CoV-2 viral load (Cycle threshold) at baseline through Day 6 between NONI and control arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Measure the proportion of subjects reaching Ct threshold (ie: unmeasurable viral load) between NONI and control |
| To Measure the efficacy of NONI in prevention of progression of COVID-19 | 28 days | Measure the proportion of subjects requiring hospitalization or ER/ED visits for COVID-19/flu-like symptoms |
| 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 | Measure the difference in 12-point COVID Symptom PROs score 0-3 (min 0 & max 36) and a QoL score from 0-100 (lower is worse) from baseline between NONI and control arms. |
| 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 | Measure the difference in proportion of subjects experiencing a reduction of ≥ 5 from baseline between NONI and control arms. |
| To measure the tolerance of NONI compared to saline placebo in participants with mild COVID-19 infection | 14 days | Number of participants lost-to-follow-up,discontinuing study treatment or number of treatments due to intolerance |
Outcome results
None listed