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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Device Feasibility
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 30, 2020

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.

Interventions

  • Device: Nitric Oxide delivered via LungFit™ system
    • Patients will receive inhalations of 80 ppm for 40 min 4 times a day

Arms, Groups and Cohorts

  • Experimental: Inhaled NO delivered using LungFit™ in addition to SST
    • Patients will receive 80 ppm iNO for 40 min 4 times a day using LungFit™ device in addition to the standard of care.
  • No Intervention: Standard of care
    • Control – Standard of care

Clinical Trial Outcome Measures

Primary Measures

  • Time to deterioration
    • Time Frame: 14 Days
    • Time to deterioration measured by need for NIV, HFNC or intubation

Secondary Measures

  • Time to NIV
    • Time Frame: 14 Days
    • Time to non-invasive ventilation
  • Time to HFNC
    • Time Frame: 14 Days
    • Time to high flow nasal cannula
  • Time to intubation
    • Time Frame: 14 days
    • Time to intubation
  • Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93%
    • Time Frame: 14 days
    • Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93%

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 22 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Beyond Air Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ashik Tal, MD, Study Director, Beyond Air
  • Overall Contact(s)
    • Vladislava Zamfirova, +1-410-236-4368, vzamfirova@beyondair.net

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