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

NCT ID: NCT04397692

Last Updated: 2022-12-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-13
• Study Completion Date: 2020-09-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Nitric Oxide delivered via LungFit™ system

Intervention Type: DEVICE

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

Standard of care

Control - Standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nitric Oxide delivered via LungFit™ system

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beyond Air Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashik Tal, MD

Role: STUDY_DIRECTOR

Beyond Air

Locations

Baptist Health Center for Clinical Research

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

BAI_COV19_01_US

Identifier Type: -

Identifier Source: org_study_id