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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04397692
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Beyond Air Inc.

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.

Condition or disease Intervention/treatment Phase
Corona Virus Infection COVID-19 SARS-CoV 2 Nitric Oxide Respiratory Disease Pneumonia, Viral Inhaled Nitric Oxide Device: Nitric Oxide delivered via LungFit™ system Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2 (US Trial)
Actual Study Start Date : June 13, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Device: Nitric Oxide delivered via LungFit™ system
Patients will receive inhalations of 80 ppm for 40 min 4 times a day

No Intervention: Standard of care
Control - Standard of care



Primary Outcome Measures :
  1. Time to deterioration [ Time Frame: 14 Days ]
    Time to deterioration measured by need for NIV, HFNC or intubation


Secondary Outcome Measures :
  1. Time to NIV [ Time Frame: 14 Days ]
    Time to non-invasive ventilation

  2. Time to HFNC [ Time Frame: 14 Days ]
    Time to high flow nasal cannula

  3. Time to intubation [ Time Frame: 14 days ]
    Time to intubation

  4. 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%


Other Outcome Measures:
  1. Need for supplemental oxygen [ Time Frame: 14 days ]
    Need for supplemental oxygen

  2. Change in viral load [ Time Frame: 30 days ]
    Change in viral load

  3. Duration of the Hospital Length of Stay (LOS) [ Time Frame: 14 days ]
    Duration of the Hospital Length of Stay (LOS)

  4. Mortality rate at Day 30 [ Time Frame: 30 days ]
    Mortality rate at Day 30



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04397692


Contacts
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Contact: Vladislava Zamfirova +1-410-236-4368 vzamfirova@beyondair.net
Contact: Enoch Bortey ebortey@beyondair.net

Locations
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United States, Arkansas
Baptist Health Center for Clinical Research Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Priyantha Wijewardane, MD         
Sponsors and Collaborators
Beyond Air Inc.
Investigators
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Study Director: Ashik Tal, MD Beyond Air
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Responsible Party: Beyond Air Inc.
ClinicalTrials.gov Identifier: NCT04397692    
Other Study ID Numbers: BAI_COV19_01_US
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Beyond Air Inc.:
COVID-19
Coronavirus
Inhaled Nitric Oxide
iNO
SARS-coronavirus
Virus
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Pneumonia, Viral
Pneumonia
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Respiratory Tract Infections
Pathologic Processes
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents