COVID-19
Conditions
Interventions
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
P
Sponsors
Ashford and St Peter's Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
Exclusion criteria
Exclusion criteria: • 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Contacts
Public ContactMs Freda Gomes
Ashford and St Peter's Hospitals NHS Foundation Trust
Outcome results
None listed