Inhaled ZYESAMI™ (Aviptadil Acetate) for the Treatment of Severe COVID-19

Short name AVICOVID-2

NCTNCT04360096Other idRLF-100_002

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Sponsor decision

Overview

Status: Terminated
Phase: Phase 2/3
Enrollment: 144 participants (actual)
Sponsor: APR Applied Pharma Research s.a. · Other
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: 15 Feb 2021
Primary completion: 15 Dec 2021
Completion: 31 Dec 2021
First posted: 24 Apr 2020
Last update posted: 3 Feb 2023
Conditions: SARS-CoV 2 · COVID · ARDS · ALI · Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) · Dyspnea

Timeline

1 trial · 1 stopped early

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20212022

Ph 2/3
AVICOVID-2
NCT04360096
15 Feb 2021 to 31 Dec 2021
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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 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 in severity of COVID-19 (i.e. 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.

Interventions

ZYESAMI™ (aviptadil acetate)Drug
PlaceboDrug
Nebulized administration of ZYESAMI™ or PlaceboDevice

Arms2

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

Primary outcomes1

Outcomes the sponsor listed as primary.

Progression to Respiratory Failure
Time frame · 28 days
Registry description
Progression to Respiratory Failure is defined as the need for mechanical ventilation, non-invasive ventilation or high flow nasal oxygen

Secondary outcomes(3)

Blood oxygenation
Time frame · 28 days
Registry description
Blood PO2 as measured by pulse oximetry
RPD Dyspnea Scale
Time frame · 28 days
Registry description
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
Distance walked in six minutes
Time frame · 28 days
Registry description
Distance walked in six minutes

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 85 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion criteria: 1. Severe COVID-19 , as defined by clinical signs indicative of severe systemic illness with COVID-19, being given oxygenation and meeting ONE of the following: Respiratory rate ≥ 30 per minute Heart rate ≥ 125 per minute SpO2 ≤ 93% on room air at sea level PaO2/FiO2 \< 300 mmHg or SpO2/FiO2 \< 315 mmHg 2. Positive test by standard RT-PCR assay or equivalent within last 7 days 3. Physician determination that patient is on SOC therapy, and will receive standard of care if patient progresses to Critical COVID-19, patient must be full CODE Exclusion criteria: 1. Evidence of Critical COVID-19 2. Inability to utilize nebulized drugs, or history of bronchospasm with inhaled medications 3. Age \<12 years; 4. Mean arterial pressure \< 65 mm Hg after initial hospital stabilization, 5. Non-COVID-19 irreversible underlying condition with projected fatal course within 6 months or with high risk of mortality; 6. Immunosuppressive treatment for transplant or other diseases associated with high mortality; 7. Stage IV cancer or cancer on active treatment with chemotherapy immunotherapy or checkpoint inhibitors; acute renal failure or chronic renal insufficiency with GFR less than 30; CHF New York Heart Association class III or IV, new neurologic disorder in the last 3 months or chronic neurologic disorder or other that would impact on assessing the resolution of severe COVID-19 respiratory failure 8. Myocardial Infarction in previous six months or troponin \>0.5 9. Recent history of venous thrombotic events (PE / DVT) within the last 3 months. 10. New diagnosis of atrial fibrillation within the last 3 months. Acceptable if greater than 3 months and well controlled in the opinion of the investigator 11. Watery diarrhea requiring replacement of 1 liter or more of iv fluids and electrolytes 12. Pregnancy

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