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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04397692
• Other study ID #: BAI_COV19_01_US
• Status: Terminated
• Phase: N/A
• Start date: June 13, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: December 2022
• Source: Beyond Air Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Inhaled Nitric Oxide
• Nitric Oxide
• Pneumonia, Viral
• Respiration Disorders
• Respiratory Aspiration
• Respiratory Disease
• Respiratory Tract Diseases
• SARS-CoV 2

Intervention

Device:
• Nitric Oxide delivered via LungFit™ system
Patients will receive inhalations of 80 ppm for 40 min 4 times a day

Locations

Country	Name	City	State
United States	Baptist Health Center for Clinical Research	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Beyond Air Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Need for supplemental oxygen	Need for supplemental oxygen	14 days
Other	Change in viral load	Change in viral load	30 days
Other	Duration of the Hospital Length of Stay (LOS)	Duration of the Hospital Length of Stay (LOS)	14 days
Other	Mortality rate at Day 30	Mortality rate at Day 30	30 days
Primary	Time to deterioration	Time to deterioration measured by need for NIV, HFNC or intubation	14 Days
Secondary	Time to NIV	Time to non-invasive ventilation	14 Days
Secondary	Time to HFNC	Time to high flow nasal cannula	14 Days
Secondary	Time to intubation	Time to intubation	14 days
Secondary	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