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WITHDRAWN
NCT05137795
PHASE3

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

Sponsor: APR Applied Pharma Research s.a.

View on ClinicalTrials.gov

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 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.

Official title: Inhaled ZYESAMI (Aviptadil Acetate) for the Treatment of Severe COVID-19 (AVICOVID-3)

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

0

Start Date

2021-12-15

Completion Date

2022-08-15

Last Updated

2026-05-14

Healthy Volunteers

No

Interventions

DRUG

ZYESAMI™ (aviptadil acetate)

Inhaled ZYESAMI™ (aviptadil acetate) 100μg 3x daily by mesh nebulizer

DRUG

Placebo

Normal Saline Inhalation

DEVICE

Nebulized administration of ZYESAMI™ or Placebo

Use of 510(k) cleared mesh nebulizer to deliver investigational product