Clinical trial NCT04397692: Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2 (US Trial)
Official title: Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2 (US Trial)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Corona Virus Infection
COVID-19
SARS-CoV 2
Nitric Oxide
Respiratory Disease
Pneumonia, Viral
Inhaled Nitric Oxide
Keywords: COVID-19
Coronavirus
Inhaled Nitric Oxide
iNO
SARS-coronavirus
Virus
Lead sponsor: Beyond Air Inc.
Sponsor class: INDUSTRY
First posted: 2020-05-21
Enrollment: 4
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: Time to deterioration
timeFrame: 14 Days
Secondary outcomes:
measure: Time to NIV
timeFrame: 14 Days
measure: Time to HFNC
timeFrame: 14 Days
measure: Time to intubation
timeFrame: 14 days
measure: Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93%
timeFrame: 14 days
Other outcomes:
measure: Need for supplemental oxygen
timeFrame: 14 days
measure: Change in viral load
timeFrame: 30 days
measure: Duration of the Hospital Length of Stay (LOS)
timeFrame: 14 days
measure: Mortality rate at Day 30
timeFrame: 30 days
Locations:
city: Little Rock
country: United States
facility: Baptist Health Center for Clinical Research
state: Arkansas
Study officials:
affiliation: Beyond Air
name: Ashik Tal, MD
role: STUDY_DIRECTOR
References: