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

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.

Study Overview

• Status: Terminated
• Conditions: COVID-19; Pneumonia, Viral; SARS-CoV 2; Corona Virus Infection; Nitric Oxide; Respiratory Disease; Inhaled Nitric Oxide
• Intervention / Treatment: Device: Nitric Oxide delivered via LungFit™ system

Detailed Description

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
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Baptist Health Center for Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Inhaled NO delivered using LungFit™ in addition to SST; 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; Patients will receive inhalations of 80 ppm for 40 min 4 times a day
NO_INTERVENTION: Standard of care; Control - Standard of care

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for supplemental oxygen	Need for supplemental oxygen	14 days
Change in viral load	Change in viral load	30 days
Duration of the Hospital Length of Stay (LOS)	Duration of the Hospital Length of Stay (LOS)	14 days
Mortality rate at Day 30	Mortality rate at Day 30	30 days

Collaborators and Investigators

• Sponsor: Beyond Air Inc.
• Investigators: Study Director: Ashik Tal, MD, Beyond Air

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 13, 2020
• Primary Completion (ACTUAL): September 30, 2020
• Study Completion (ACTUAL): September 30, 2020

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (ACTUAL): May 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Coronavirus; COVID-19; Virus; Inhaled Nitric Oxide; iNO; SARS-coronavirus
• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections; Respiratory Aspiration; Pneumonia, Viral; Respiration Disorders; Respiratory Tract Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Antioxidants; Free Radical Scavengers; Endothelium-Dependent Relaxing Factors; Gasotransmitters; Nitric Oxide
• Other Study ID Numbers: BAI_COV19_01_US

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes