itric Oxide Nasal Spray for COVID-19 treatment
- Conditions
- COVID-19Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2020-004994-27-GB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 50
•Capable of understanding and providing signed informed consent and ability to adhere to the requirements and restrictions of this protocol;
•Men and Women 18 years to 70 years 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 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;
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
•Not fit to consent and unable to follow the protocol ;
•Men and Women Age >70 years;
•Current tracheostomy or laryngectomy;
•Concomitant respiratory therapy such as oxygen or ventilator 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 spray
•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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this trial is to shorten the duration of COVID-19 infectivity through day 6 from randomisation using Nitric Oxide Nasal Spray. <br>;Secondary Objective: The secondary objectives are to assess the reduction of viral load/concentration in participants and assess tolerability of NONS in participants with COVID-19.;Primary end point(s): Difference in SARS-CoV-2 viral load (Cycle threshold) from baseline through Day 6 between NONS and control arms.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Difference in proportion of subjects reaching Ct threshold (ie: unmeasurable viral load) between NONS and control at Day 2, 4, and 6.<br>•Difference in time-to Ct threshold (ie: unmeasurable viral load) between NONS and control.<br>•Proportion of subjects requiring hospitalization or ER/ED visits for COVID-19/flu-like symptoms by 18 days following randomization;<br>•Difference in symptom score from baseline through Day 6 between NONS and control arms.<br>•Difference in proportion of subjects experiencing a reduction of = 5 from baseline between NONS and control at Day 2, 4, 6, 9 and 18.<br>•Difference in proportion of subjects with reduction to a score of zero from baseline between NONS and control at Day 2, 4, 6, 9 and 18.<br>•Adverse events and discontinuation of treatment<br>•Adverse events at day 18 post enrolment.<br>;Timepoint(s) of evaluation of this end point: 18 days to 6 months