Clinical Efficacy of Nitric Oxide Nasal Spray (NONS) for the Treatment of Mild COVID-19 Infection

INTERVENTION: Product Name: Nitric Oxide Nasal Spray Pharmaceutical Form: Nasal spray INN or Proposed INN: Nitric Oxide Concentration unit: µl microlitre(s) Concentration type: range Concentration number: 120‐140 Pharmaceutical form of the placebo: Nasal spray Route of administration of the placebo: Nasal use CONDITION: COVID‐19 Therapeutic area: Diseases [C] ‐ Respiratory Tract Diseases [C08] PRIMARY OUTCOME: 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. ; Primary end point(s): Difference in SARS‐CoV‐2 viral load (Cycle threshold) from baseline through Day 6 between NONS and control arms. 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. SECONDARY OUTCOME: 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.; • Difference in time‐to Ct threshold (ie: unmeasurable viral load) between NONS and control.; • Proportion of subjects requiring hospitalization or ER/ED visits for COVID‐19/flu‐like symptoms by 18 days following randomization;; • Difference in symptom score from baseline through Day 6 between NONS and control arms.; • Difference in proportion of subjects experiencing a reduction of = 5 from baseline between NONS and control at Day 2, 4, 6, 9 and 18.; • 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.; • Adverse events and discontinuation of treatment; • Adverse events at day 18 post enrolment.; Timepoint(s) of evaluation of this end point: 18 days to 6 months 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 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 o