Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2 (US Trial)

Study Overview
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Brief Summary
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The purpose of this open label, randomized, study is to obtain information on the safety and efficacy of 80 ppm Nitric Oxide given in addition to the standard of care of patients with COVID-19 caused by SARS-CoV-2.

Detailed Description
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Nitric Oxide (NO) is a small endogenously produced molecule recognized to play a critical role in the function of several body systems including the vasodilatation of smooth muscle, neurotransmission, regulation of wound healing and inhibition of pathogens. In-vitro studies have shown that NO inhibits the replication cycle of the severe acute respiratory syndrome coronavirus (SARS CoV) in vitro. The suggested mechanisms of actions of NO on SARS are an effect on the fusion between the S protein and its cognate receptor, ACE2, and reduction in viral RNA production in the early steps of viral replication. The primary aim of this feasibility study is to investigate the safety of intermittent NO, delivered via inhalation, in hospitalized patients with COVID-19. The primary endpoint in the study will be time to deterioration of respiratory symptoms determined by escalation to either non-invasive ventilation (NIV), high-flow nasal cannula (HFNC), or intubation.

Official Title
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Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2 (US Trial)

Conditions
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Corona Virus Infection, COVID-19, SARS-CoV 2, Nitric Oxide, Respiratory Disease, Pneumonia, Viral, Inhaled Nitric Oxide

Intervention / Treatment
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* Device: Nitric Oxide delivered via LungFit™ system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrollment within 24 hours of hospital admission of patients diagnosed with COVID-19 Patients with oxygen saturation less than 93 % on room air Shortness of breath, with symptom onset within the previous 8 days. Female subjects of childbearing potential should take adequate measures to avoid pregnancy Signed informed consent by the subject Exclusion Criteria: Patients who are treated with or require high flow nasal cannula, CPAP, intubation, mechanical ventilation, or tracheostomy Diagnosis of acute respiratory distress syndrome Subjects diagnosed with immunodeficiency, with history of congestive or unstable heart disease, left ventricular dysfunction or myocardial damage, severe pulmonary hypertension and/or unstable hypertension Patients receiving drugs that have contraindications with NO. Breastfeeding or pregnancy as evidenced by a positive pregnancy test. Patients with active pulmonary malignancy or lung transplant Patients with a history of frequent epistaxis or significant hemoptysis

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 65 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: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inhaled NO delivered using LungFit™ in addition to SST<br>Patients will receive 80 ppm iNO for 40 min 4 times a day using LungFit™ device in addition to the standard of care. | Device: Nitric Oxide delivered via LungFit™ system<br>* Patients will receive inhalations of 80 ppm for 40 min 4 times a day<br>|
| No Intervention: Standard of care<br>Control - Standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to deterioration | Time to deterioration measured by need for NIV, HFNC or intubation | 14 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to NIV | Time to non-invasive ventilation | 14 Days | 
| Time to HFNC | Time to high flow nasal cannula | 14 Days | 
| Time to intubation | Time to intubation | 14 days | 
| Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93% | Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93% | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iNO, COVID-19, Coronavirus, Inhaled Nitric Oxide, SARS-coronavirus, Virus