COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04443868

Jeremy Road, MD

Chris Miller, chris@sanotize.com (PI email not reported)

2020-06-23

Withdrawn

RCT

Randomized

Parallel

Blind label

unclear

Treatment

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.

- 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).

2

Sanotize Research and Development corp.

18

100

None

Mild disease at enrollment

1: Mild disease at enrollment

0

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

None

Phase 2

[{"arm_notes": "", "treatment_id": 892, "treatment_name": "Nitric oxide releasing solution", "treatment_type": "Other anti-infectives", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]