COVID-19 Clinical Trial
Official title:
Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2 (US Trial)
Verified date | December 2022 |
Source | Beyond Air Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Baptist Health Center for Clinical Research | Little Rock | Arkansas |
Lead Sponsor | Collaborator |
---|---|
Beyond Air Inc. |
United States,
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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