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

Not Applicable

Terminated

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

• Registration Number: NCT04397692
• Lead Sponsor: Beyond Air Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-21
• Study Start: 2020-06-13
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-14
• Last Update Posted: 2022-12-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhaled NO delivered using LungFit™ in addition to SST	Nitric Oxide delivered via LungFit™ system	Patients will receive 80 ppm iNO for 40 min 4 times a day using LungFit™ device in addition to the standard of care.

Primary Outcome Measures

Name	Time	Method
Time to deterioration	14 Days	Time to deterioration measured by need for NIV, HFNC or intubation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Baptist Health Center for Clinical Research; 🇺🇸 Little Rock, Arkansas, United States