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Inhaled ZYESAMI™ (Aviptadil Acetate) for the Treatment of Moderate and Severe COVID-19 (AVICOVID-2)

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ClinicalTrials.gov Identifier: NCT04360096
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
NeuroRx, Inc.

Brief Summary:

Brief Summary:

SARS-CoV-2 virus infection is known to cause Lung Injury that begins as dyspnea and exercise intolerance, but may rapidly progress to Critical COVID-19 with Respiratory Failure and the need for noninvasive or mechanical ventilation. Mortality rates as high as 80% have been reported among those who require mechanical ventilation, despite best available intensive care.

Patients with moderate and severe COVID-19 by FDA definition who have not developed respiratory failure be treated with nebulized ZYESAMI™ (aviptadil acetate, a synthetic version of Vasoactive Intestinal Polypeptide (VIP)) 100 μg 3x daily plus Standard of Care vs. placebo + Standard of Care using an FDA 501(k) cleared mesh nebulizer.

The primary outcome will be progression to in severity of COVID-19 (i.e. moderate progressing to severe or critical OR severe progressing to critical) over 28 days. Secondary outcomes will include blood oxygenation as measured by pulse oximetry, dyspnea, exercise tolerance, and levels of TNFα IL-6 and other cytokines.


Condition or disease Intervention/treatment Phase
SARS-CoV 2 COVID ARDS ALI Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) Dyspnea Drug: ZYESAMI™ (aviptadil acetate) Drug: Placebo Device: Nebulized administration of ZYESAMI™ or Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter Randomized Placebo-controlled Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Only the study pharmacist will be aware of treatment assignment
Primary Purpose: Treatment
Official Title: Inhaled ZYESAMI™ for the Treatment of Moderate and Severe COVID-19
Actual Study Start Date : February 15, 2021
Estimated Primary Completion Date : August 15, 2021
Estimated Study Completion Date : September 1, 2021


Arm Intervention/treatment
Experimental: Moderate COVID-19 ZYESAMI™
Patients with Moderate COVID-19 to be treated with inhaled ZYESAMI™ (aviptadil) by mesh nebulizer 100μg 3x daily
Drug: ZYESAMI™ (aviptadil acetate)
Inhaled ZYESAMI™ (aviptadil acetate) 100μg 3x daily by mesh nebulizer

Device: Nebulized administration of ZYESAMI™ or Placebo
Use of 510(k) cleared mesh nebulizer to deliver investigational product

Experimental: Moderate COVID-19 Placebo
Patients with Moderate COVID-19 to be treated with inhaled placebo 3x daily
Drug: Placebo
Normal Saline Inhalation

Device: Nebulized administration of ZYESAMI™ or Placebo
Use of 510(k) cleared mesh nebulizer to deliver investigational product

Experimental: Severe COVID-19 ZYESAMI™
Patients with Severe COVID-19 to be treated with inhaled ZYESAMI™ (aviptadil) by mesh nebulizer 100μg 3x daily
Drug: ZYESAMI™ (aviptadil acetate)
Inhaled ZYESAMI™ (aviptadil acetate) 100μg 3x daily by mesh nebulizer

Device: Nebulized administration of ZYESAMI™ or Placebo
Use of 510(k) cleared mesh nebulizer to deliver investigational product

Experimental: Severe COVID-19 Placebo
Patients with Severe COVID-19 to be treated with inhaled placebo 3x daily
Drug: Placebo
Normal Saline Inhalation

Device: Nebulized administration of ZYESAMI™ or Placebo
Use of 510(k) cleared mesh nebulizer to deliver investigational product




Primary Outcome Measures :
  1. Progression to Respiratory Failure [ Time Frame: 28 days ]
    Progression to Respiratory Failure is defined as the need for mechanical ventilation, non-invasive ventilation or high flow nasal oxygen


Secondary Outcome Measures :
  1. Blood oxygenation [ Time Frame: 28 days ]
    Blood PO2 as measured by pulse oximetry

  2. RDP Dsypnea Scale [ Time Frame: 28 days ]

    0 = no shortness of breath at all 0.5 = very, very slight shortness of breath

    1. = very mild shortness of breath
    2. = mild shortness of breath
    3. = moderate shortness of breath or breathing difficulty
    4. = somewhat severe shortness of breath
    5. = strong or hard breathing

    7 = severe shortness of breath or very hard breathing 8 9 = extremely severe shortness of breath 10 = shortness of breath so severe you need to stop the exercise or activity


  3. Distance walked in six minutes [ Time Frame: 28 days ]
    Distance walked in six minutes



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Ages Eligible for Study:   12 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Moderate or Severe COVID-19 by FDA definition with no evidence of Respiratory Failure
  2. Capable of using mesh nebulizer to administer medication with assistance if needed

Exclusion Criteria:

  1. Evidence of Respiratory Failure
  2. Use or impending use of ventilation or high flow nasal oxygen 20L or greater

4) Age <12 years; 5) Diastolic pressure < 65 mm Hg; 6) Irreversible underlying condition with projected fatal course; 7) Immunosuppressive treatment for transplant or other reasons; 8) Cancer, renal failure, congestive heart failure, neurological disorder 9) Recent myocardial infarction with Troponin >0.5


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): NCT04360096


Contacts
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Contact: Robert E Besthof, MIM +48425461134 rbesthof@neurorxpharma.com

Locations
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United States, California
St. Jude Medical Center Recruiting
Fullerton, California, United States, 92835
Contact: Linda Gozar       Linda.Gozar@stjoe.org   
Principal Investigator: David Park, MD         
University of California - Irvine Recruiting
Irvine, California, United States, 92697
Contact: Rosie Magallon       rmagallo@hs.uci.edu   
Principal Investigator: Richard Lee, MD         
United States, Kentucky
University of Louisville Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Elizabeth Cooke       Elizabetha.cooke@louisville.edu   
Principal Investigator: Rainer Lenhardt, MD         
Sponsors and Collaborators
NeuroRx, Inc.
Investigators
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Study Chair: Jonathan C Javitt, MD, MPH NeuroRx
Additional Information:
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Responsible Party: NeuroRx, Inc.
ClinicalTrials.gov Identifier: NCT04360096    
Other Study ID Numbers: RLF-100_002
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by NeuroRx, Inc.:
Corona Virus
VIP
Aviptadil
Vasoactive Intestinal Polypeptide
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Dyspnea
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Signs and Symptoms, Respiratory
Thoracic Injuries
Wounds and Injuries