Status:
TERMINATED
Inhaled ZYESAMI™ (Aviptadil Acetate) for the Treatment of Severe COVID-19
Lead Sponsor:
APR Applied Pharma Research s.a.
Conditions:
SARS-CoV 2
COVID
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
Detailed Description: Attack of the Alveolar Type II (ATII) cell via its ACE2 surface receptor by the SARS-CoV-2 virus leads to respiratory failure, morbidity, and frequently mortality in COVID-19. T...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Positive test by standard RT-PCR assay or equivalent within last 7 days
- 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:
- Evidence of Critical COVID-19
- Inability to utilize nebulized drugs, or history of bronchospasm with inhaled medications
- Age \<12 years;
- Mean arterial pressure \< 65 mm Hg after initial hospital stabilization,
- Non-COVID-19 irreversible underlying condition with projected fatal course within 6 months or with high risk of mortality;
- Immunosuppressive treatment for transplant or other diseases associated with high mortality;
- 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
- Myocardial Infarction in previous six months or troponin \>0.5
- Recent history of venous thrombotic events (PE / DVT) within the last 3 months.
- 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
- Watery diarrhea requiring replacement of 1 liter or more of iv fluids and electrolytes
- Pregnancy
Exclusion
Key Trial Info
Start Date :
February 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT04360096
Start Date
February 15 2021
End Date
December 31 2021
Last Update
February 3 2023
Active Locations (13)
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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
University of Miami Leonard M. Miller School of Medicine (UMMSM)
Miami, Florida, United States, 33136
4
Advent Health Research Institute
Orlando, Florida, United States, 32803