Status:
COMPLETED
Safety and Feasibility of Amniotic Fluid as a Treatment for COVID-19 Patients
Lead Sponsor:
University of Utah
Conditions:
SARS CoV-2
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to explore the effectiveness of processed human amniotic fluid as a treatment for COVID-19.
Detailed Description
Past use of human amniotic products (i.e., membrane and fluid) has previously been FDA-approved as a human cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) under 21 CFR 1271 for tissue i...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age \>18
- SARS CoV-2 laboratory positive test, obtained within 14 days of enrollment
- Hospitalized
- COVID-19 symptomatic (cough, fevers, shortness of breath, and/or sputum production)
- Has a room air pulse oximetry of ≤94% and requires supplemental oxygen therapy
- Patients of childbearing potential who agree to use acceptable methods of contraception for 90 days after last administration of study investigational product (IP)
- Patients who are receiving standard of care therapies for COVID-19 that are not FDA approved are eligible for this study
- Subjects must be able to consent to the study (i.e., Glasgow Coma Scale score of ≥14)
- Patients are required to have controlled blood pressure of \<160/96 and a pulse of \<110.
- Exclusion criteria:
- Patients on invasive mechanical ventilation (e.g., endotracheal intubation)
- Chronic home oxygen utilization
- Home or current use of immunosuppressive medications (including steroids)
- Women who are pregnant, breastfeeding, or become pregnant during the study
- Patients on non-invasive positive pressure ventilation
- Patients on \>12 liters per minute via non-rebreather (NRB) or \>80% oxygen via high flow nasal cannula
- Patients who, in the opinion of the PI, have impending respiratory failure, defined as requiring rapidly escalating oxygen supplementation
- Patients with a hemoglobin \<9 mg/dL
- Patients diagnosed with Stage 4 or 5 chronic kidney disease (CKD)
- Patients with diagnosed New York Heart Association (NYHA) class 4 or 5 congestive heart failure
- Patients with a left ventricular assist device (LVAD)
- Patients with thromboembolic phenomena
- Patients with Type 2 and above heart block
- Patients with established positive bacterial blood cultures prior to enrollment
- Patients with ongoing pericardial effusion or ascites
- Patients with clinically significant arrhythmia
- Patients with liver function tests (ALT or AST) \>3x normal
- Patients with untreated HIV infection
- Patients diagnosed with end-stage organ disease
Exclusion
Key Trial Info
Start Date :
October 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2023
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04497389
Start Date
October 28 2020
End Date
February 15 2023
Last Update
December 21 2023
Active Locations (1)
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1
University of Utah Health
Salt Lake City, Utah, United States, 84132