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

  • STATUS
    Recruiting
  • participants needed
    20
  • sponsor
    Beyond Air Ltd
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Updated on 1 February 2023
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dyspnea
oxygen saturation
nitric oxide
oximetry
covid-19
SARS
acute respiratory syndrome (sars)

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.

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.

Details
Condition Respiratory Tract Diseases, Respiratory disorder, Viral pneumonia, Nitric Oxide, Corona Virus Infection, Covid 19, SARS-CoV 2, Inhaled Nitric Oxide
Age 22years - 65years
Treatment Nitric Oxide delivered via LungFit™ system
Clinical Study IdentifierNCT04397692
SponsorBeyond Air Ltd
Last Modified on1 February 2023

Eligibility

 Yes No Not Sure

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
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dyspnea
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