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.
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.
Drug: Nitric Oxide-Releasing Drug
Nasal Spray + Nasal Irrigation
Other Name: nitric oxide
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).