Loading clinical trials...

Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2 (US Trial) | Clinical Trials | Clareo Health

TERMINATEDNA

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

NCT04397692•Beyond Air Inc.

Summary

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

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.

Eligibility

Age

22 - 65 years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

June 13, 2020

Primary Completion Date

September 30, 2020

Completion Date

September 30, 2020

Last Updated

December 16, 2022

Enrollment

ACTUAL participants

Conditions

Corona Virus InfectionCOVID-19SARS-CoV 2Nitric OxideRespiratory DiseasePneumonia, ViralInhaled Nitric Oxide

Interventions

Nitric Oxide delivered via LungFit™ system

DEVICE

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

NCT07221162

COVID-19

View study

RECRUITINGNA

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

NCT06082518

Post COVID-19 ConditionPost-COVID-19 Syndrome+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 16, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease

Dime La VerDAD: Verify, Debunk, and Disseminate

Positron Emission Tomography (PET) Imaging of Thrombosis