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

Primary Purpose

Corona Virus Infection, COVID-19, SARS-CoV 2

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nitric Oxide delivered via LungFit™ system
Sponsored by
Beyond Air Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Corona Virus Infection focused on measuring COVID-19, Coronavirus, Inhaled Nitric Oxide, iNO, SARS-coronavirus, Virus

Eligibility Criteria

22 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baptist Health Center for Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Inhaled NO delivered using LungFit™ in addition to SST

Standard of care

Arm Description

Patients will receive 80 ppm iNO for 40 min 4 times a day using LungFit™ device in addition to the standard of care.

Control - Standard of care

Outcomes

Primary Outcome Measures

Time to deterioration
Time to deterioration measured by need for NIV, HFNC or intubation

Secondary Outcome Measures

Time to NIV
Time to non-invasive ventilation
Time to HFNC
Time to high flow nasal cannula
Time to intubation
Time to intubation
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%

Full Information

First Posted
May 19, 2020
Last Updated
December 14, 2022
Sponsor
Beyond Air Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04397692
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment
Study Start Date
June 13, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beyond Air Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inhaled NO delivered using LungFit™ in addition to SST
Arm Type
Experimental
Arm Description
Patients will receive 80 ppm iNO for 40 min 4 times a day using LungFit™ device in addition to the standard of care.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Control - Standard of care
Intervention Type
Device
Intervention Name(s)
Nitric Oxide delivered via LungFit™ system
Intervention Description
Patients will receive inhalations of 80 ppm for 40 min 4 times a day
Primary Outcome Measure Information:
Title
Time to deterioration
Description
Time to deterioration measured by need for NIV, HFNC or intubation
Time Frame
14 Days
Secondary Outcome Measure Information:
Title
Time to NIV
Description
Time to non-invasive ventilation
Time Frame
14 Days
Title
Time to HFNC
Description
Time to high flow nasal cannula
Time Frame
14 Days
Title
Time to intubation
Description
Time to intubation
Time Frame
14 days
Title
Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93%
Description
Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93%
Time Frame
14 days
Other Pre-specified Outcome Measures:
Title
Need for supplemental oxygen
Description
Need for supplemental oxygen
Time Frame
14 days
Title
Change in viral load
Description
Change in viral load
Time Frame
30 days
Title
Duration of the Hospital Length of Stay (LOS)
Description
Duration of the Hospital Length of Stay (LOS)
Time Frame
14 days
Title
Mortality rate at Day 30
Description
Mortality rate at Day 30
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashik Tal, MD
Organizational Affiliation
Beyond Air
Official's Role
Study Director
Facility Information:
Facility Name
Baptist Health Center for Clinical Research
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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