Status:
WITHDRAWN
Nitric Oxide Releasing Solution to Treat and Prevent Exacerbation of Mild COVID-19 Infection
Lead Sponsor:
Sanotize Research and Development corp.
Conditions:
SARS-CoV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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. * T...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04443868
Start Date
January 1 2021
End Date
July 1 2021
Last Update
July 16 2021
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