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

Beyond Air Inc.4 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

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

Interventions

Nitric Oxide delivered via LungFit™ systemDEVICE

Patients will receive inhalations of 80 ppm for 40 min 4 times a day

Eligibility

Sex: ALLMin age: 22 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Baptist Health Center for Clinical Research

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

Time to deterioration

Time to deterioration measured by need for NIV, HFNC or intubation

Time frame: 14 Days

Secondary Outcomes

Time to NIV

Time to non-invasive ventilation

Time frame: 14 Days

Time to HFNC

Time to high flow nasal cannula

Time frame: 14 Days

Time to intubation

Time frame: 14 days

Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93%

Time frame: 14 days

Data from ClinicalTrials.gov

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