Status:
TERMINATED
Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2 (US Trial)
Lead Sponsor:
Beyond Air Inc.
Conditions:
Corona Virus Infection
COVID-19
Eligibility:
All Genders
22-65 years
Phase:
NA
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 ...
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2020
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04397692
Start Date
June 13 2020
End Date
September 30 2020
Last Update
December 16 2022
Active Locations (1)
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1
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States, 72205