Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Critical COVID-19 With Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS), Corona Virus Infection, Acute Lung Injury

In brief

Novel Corona Virus (SARS-CoV-2) is known to cause Respiratory Failure, which is the hallmark of Acute COVID-19, as defined by the new NIH/FDA classification. Approximately 50% of those who develop Critical COVID-19 die, despite intensive care and mechanical ventilation. Patients with Critical COVID-19 and respiratory failure, currently treated with high flow nasal oxygen, non-invasive ventilation or mechanical ventilation will be treated with ZYESAMI (aviptadil), a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP) plus maximal intensive care vs. placebo + maximal intensive care. Patients will be randomized to intravenous Aviptadil will receive escalating doses from 50 -150 pmol/kg/hr over 12 hours.

Key facts

Study ID

NCT04311697

Run by

APR Applied Pharma Research s.a.

People needed

203

Starts

2020-05-15

Expected to finish

2021-02-22

Last updated by the study team

2023-07-24

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Critical COVID-19 with respiratory failure
• Physician determination that patient is on maximal conventional medical therapy

You may not qualify if…

• Pregnancy (pregnant women may apply for open label treatment under compassionate care IND
• Age <18 years
• Mechanical ventilation for more than 7 days in primary cohort. Mechanical ventilation>21 days in the exploratory cohort
• Mean Arterial Pressure < 65 mm Hg with use of pressor per ICU protocol
• Irreversible condition (other than COVID-19) with projected fatal course
• ECMO
• Current or recent (within 30 d) enrollment in another investigational trial of anti-IL6 drug;
• Active diagnosis of Acquired immune deficiency syndrome;
• Transplant patients currently immunosuppressed;
• Chemotherapy-induced neutropenia (granulocyte count <1000/mm3);
• Cardiogenic shock; congestive heart failure - NYHA Class 3 or 4;
• Recent myocardial infarction - within last 6 months and troponin > 0.5
• Anuria (urine output < 50 ml/d) or other signs of multi-organ failure
• Severe liver disease with portal hypertension;
• Recent stroke or head trauma within last 12 months
• Increased intracranial pressure, or other serious neurologic disorder;
• Liquid Diarrhea more than 3x/day; defined as more than 3 non-bloody watery stools within a 24-hour period, requiring additional fluid and electrolyte supplementation

Where it is running

• St. Jude Medical Center — Fullerton, California, United States
• University of California - Irvine — Irvine, California, United States
• Miller School of Medicine / University of Miami Medical Center — Miami, Florida, United States
• Baptist Hospital of Miami — Miami, Florida, United States
• University of Louisville Hospital — Louisville, Kentucky, United States
• Heartland/Mosaic Health — Saint Joseph, Missouri, United States
• Hendrick Health — Abilene, Texas, United States
• Texas Health Harris Methodist Hospital — Fort Worth, Texas, United States
• Texas Health Hospital Frisco — Frisco, Texas, United States
• Houston Methodist Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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