E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of this trial is to shorten the duration of COVID-19 infectivity through day 6 from randomisation using Nitric Oxide Nasal Spray.
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to assess the reduction of viral load/concentration in participants and assess tolerability of NONS in participants with COVID-19. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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;
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E.4 | Principal 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).
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E.5 End points |
E.5.1 | Primary end point(s) |
Difference in SARS-CoV-2 viral load (Cycle threshold) from baseline through Day 6 between NONS and control arms. |
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E.5.2 | 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.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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All randomised participants are to be followed up until 18 days post-randomisation. The study end date is usually the date of the last visit/data item of the last patient undergoing the trial. Once all patients have finished their treatment (9 days) and last follow up call of the last patient (after 18 days) that will be considered end of trial recruitment. Completion of data analysis and study report will be taken as End of Trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 1 |