Phase 3
N=203
Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure
Critical COVID-19 With Respiratory Failure · Acute Respiratory Distress Syndrome (ARDS) · Corona Virus Infection · Acute Lung Injury
Bottom Line
View on ClinicalTrials.gov: NCT04311697 ↗Enrolled (actual)
203
Serious AEs
45.9%
Results posted
Jul 2023
Primary outcome: Primary: Resolution of Respiratory Failure (Alive and Free of Respiratory Failure) — 72; 33 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aviptadil by intravenous infusion + standard of care (Drug); Normal Saline Infusion + standard of care (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- APR Applied Pharma Research s.a.
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Resolution of Respiratory Failure (Alive and Free of Respiratory Failure) |
72; 33 | — |
| SECONDARY Number of Participants Alive at Day 60 |
85; 35 | — |
| SECONDARY Number of Participants Achieving a Score of 6-8 on NIAID Ordinal Score Through Day 60 |
76; 35 | — |
| SECONDARY Oxygenation Index as Measured by PaO2:FiO2 Ratio |
139.2; 116.2 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Critical COVID-19 with respiratory failure
- Physician determination that patient is on maximal conventional medical therapy
Exclusion Criteria
- Pregnancy (pregnant women may apply for open label treatment under compassionate care IND
- Age 21 days in the exploratory cohort
- Mean Arterial Pressure 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
Data sourced from ClinicalTrials.gov (NCT04311697). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.