Status:
COMPLETED
Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure
Lead Sponsor:
APR Applied Pharma Research s.a.
Conditions:
Critical COVID-19 With Respiratory Failure
Acute Respiratory Distress Syndrome (ARDS)
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
PHASE3
Brief 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 Cri...
Detailed Description
Acute Lung Injury, which triggers Critical COVID-19 is a known lethal complication of Corona Virus (SARS-CoV-2) infection. Conventional medical therapy, including intensive care and respiratory suppor...
Eligibility Criteria
Inclusion
- Critical COVID-19 with respiratory failure
- Physician determination that patient is on maximal conventional medical therapy
Exclusion
- 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
Key Trial Info
Start Date :
May 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2021
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT04311697
Start Date
May 15 2020
End Date
February 22 2021
Last Update
July 24 2023
Active Locations (10)
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1
St. Jude Medical Center
Fullerton, California, United States, 92835
2
University of California - Irvine
Irvine, California, United States, 92697
3
Miller School of Medicine / University of Miami Medical Center
Miami, Florida, United States, 33136
4
Baptist Hospital of Miami
Miami, Florida, United States, 33176