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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04397692
Other study ID # BAI_COV19_01_US
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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