Phase 3 Clinical Study Evaluating Nitric Oxide Nasal Spray (NONS) Efficacy To Treat and Prevent the Exacerbation of Infection in Individuals With Documented Asymptomatic or Mild COVID-19

Study Overview
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Brief Summary
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Study Design: This is a double-blind, placebo-controlled, Phase 3 clinical efficacy study evaluating NONS in adult volunteers as a treatment for high-risk asymptomatic and symptomatic individuals with mild COVID-19 infection. thru facility).

Detailed Description
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Study Design: This is a double-blind, placebo-controlled, Phase 3 clinical efficacy study evaluating NONS in adult volunteers as a treatment for high-risk asymptomatic and symptomatic individuals with mild COVID-19 infection.

Official Title
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A Double-Blinded, Placebo-Controlled Parallel, Phase 3 Clinical Efficacy Study Evaluating Nitric Oxide Nasal Spray (NONS) To Treat and Prevent the Exacerbation of Infection in Individuals With Documented Asymptomatic or Mild COVID-19

Conditions
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Covid19

Intervention / Treatment
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* Drug: to be given as a treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria: 18 years and above. COVID-19 infection Confirmed with a laboratory SARS-CoV-2 RT-PCR nasal swab or antigen test. COVID-19 test specimen must be collected 48 hours prior to Screenings. Mild COVID-19 Infection defined as: No Pneumonia (negative by chest auscultation or Chest X Ray). No Shortness of breath. No Tachypnea (respiratory rate <20 breathes/min) No Hypoxia (Oxygen saturation >93% on RA) Fever <38 degrees. No Chest Pain. No Mental Status Change. Asymptomatic participants must be high risk defined as (any of the following): Smokers (at least 5 cigarettes per day) BMI (> 40 kg/m2) History of cardiac or chronic lung disease Clotting predisposing conditions (hemophilia, von Willebrand's disease) Sickle cell disease Immunocompromised such as HIV , cancer , on immunosuppressant medications Exclusion Criteria: Participants diagnosed with another (non-COVID-19) respiratory infection. Participants with a current tracheostomy or laryngectomy. Participants who are receiving concomitant respiratory therapy such as oxygen, positive airway pressure or ventilatory support. NOTE: Positive airway pressure for obstructive sleep apnea is permitted if the treatment was established with good compliance for at least 3 months before study enrollment. Participants with newly diagnosed illnesses that are not deemed stable by the participant's primary care physician), based on Investigator assessment of medical history during Screening. Participants who use intranasally dosed drugs, prescriptions or over-the-counter medications such as fluticasone. Participants who need hospitalization for reasons other than COVID-19 infection. Participants who are unable to safely self-administer the nasal spray as directed. Clinical signs indicative of moderate, severe, or critical COVID severity symptoms (requirement for supplemental oxygen, limitation of activities due to COVID-19 symptoms). Females who are breastfeeding, pregnant, or attempting to become pregnant. Participants who have experienced symptoms of COVID-19 for more than 7 days prior to randomization. Participants who have any other condition that, in the opinion of the Investigator, would interfere with a participant's ability to adhere to the protocol (eg, participants who are mentally or neurologically disabled and who are considered not fit for their participation in the study), interfere with assessment of the investigational product, or compromise the safety of the participant, or the quality of the data.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomized, double-blind, placebo-controlled, Phase 3 clinical efficacy study evaluating NONS in healthy adult volunteers as a treatment for high-risk asymptomatic and symptomatic individuals with mild COVID-19 infection.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment arm<br>Nitric Oxide Nasal Spray Enovid | Drug: to be given as a treatment<br>* Nitric Oxide Nasal Spray Enovid<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: to be given as a treatment<br>* Nitric Oxide Nasal Spray Enovid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of NONS compared to placebo in participants with COVID-19 to reduce the need of urgent care | To evaluate the efficacy of NONS compared to placebo to reduce the need for urgent medical care in term of the need of visiting the emergency room in participants with COVID-19 infection and reduce of symptoms. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of NONS compared to placebo in participants with COVID-19 to reduce mortality | To evaluate the efficacy of NONS compared to placebo to reduce mortality of participants with COVID-19 | 6 months | 
| efficacy of NONS compared to placebo in participants with COVID-19 on viral load reduction | Viral load reduction measure in copies per ml in participants with mild COVID-19 infection. | 6 months | 
| efficacy of NONS compared to placebo in participants with COVID-19 to reduce time of clinical symptoms improvement | Median time reduction to COVID-19 clinical symptoms improvement in days | 6 months | 
| Incidence of Treatment-Emergent Adverse Events | Incidence of Treatment-Emergent Adverse Events to assess Safety and Tolerability] | 6 months |