NCT04397692

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Beyond Air Inc. · Industry
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Corona Virus Infection
• COVID-19
• SARS-CoV 2
• Nitric Oxide
• Respiratory Disease
• Pneumonia, Viral
• Inhaled Nitric Oxide

Interventions

Type	Name	Description
DEVICE	Nitric Oxide delivered via LungFit™ system	Patients will receive inhalations of 80 ppm for 40 min 4 times a day

Timeline

• Start date: 2020-06-13
• Primary completion: 2020-09-30
• Completion: 2020-09-30
• First posted: 2020-05-21
• Last updated: 2022-12-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study