The purpose of this study is to explore the effectiveness of processed human amniotic fluid as a treatment for COVID-19.
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 injury; and has been used to reduce inflammation and fibrosis in
patients with a variety of ailments. Given this, the investigators hypothesize that
intravenously (IV) administered processed sterile filtered amniotic fluid will reduce
inflammation in COVID-19 patients, and improve secondary clinical outcomes. Specifically, the
investigators hypothesize that patients who receive IV administered hAF will see a 50%
reduction in mean C-reactive protein levels following treatment.
Biological: Human Amniotic Fluid
Patients will receive 10ml intravenous hAF each day for 5 consecutive days.
Inclusion criteria:
1. Age >18
2. SARS CoV-2 laboratory positive test, obtained within 14 days of enrollment
3. Hospitalized
4. COVID-19 symptomatic (cough, fevers, shortness of breath, and/or sputum production)
5. Has a room air pulse oximetry of ≤94% and requires supplemental oxygen therapy
6. Patients of childbearing potential who agree to use acceptable methods of
contraception for 90 days after last administration of study IP
7. Patients who are receiving standard of care therapies for COVID-19 that are not FDA
approved are eligible for this study
8. Subjects must be able to consent to the study (i.e., Glasgow Coma Scale score of ≥14)
9. Patients are required to have controlled blood pressure of <160/96 and a pulse of
<110.
Exclusion criteria:
1. Patients on invasive mechanical ventilation (e.g., endotracheal intubation)
2. Chronic home oxygen utilization
3. Home or current use of immunosuppressive medications (including steroids)
4. Women who are pregnant, breastfeeding, or become pregnant during the study
5. Patients on non-invasive positive pressure ventilation
6. Patients on >12 liters per minute via non-rebreather (NRB) or >80% oxygen via high
flow nasal cannula
7. Patients who, in the opinion of the PI, have impending respiratory failure, defined as
requiring rapidly escalating oxygen supplementation
8. Patients with a hemoglobin <9 mg/dL
9. Patients diagnosed with Stage 4 or 5 chronic kidney disease (CKD)
10. Patients with diagnosed NYHA class 4 or 5 congestive heart failure
11. Patients with a left ventricular assist device (LVAD)
12. Patients with thromboembolic phenomena
13. Patients with Type 2 and above heart block
14. Patients with established positive bacterial blood cultures prior to enrollment
15. Patients with ongoing pericardial effusion or ascites
16. Patients with clinically significant arrhythmia
17. Patients with liver function tests (ALT or AST) >3x normal
18. Patients with untreated HIV infection
19. Patients diagnosed with end-stage organ disease
University of Utah Health
Salt Lake City, Utah, United States
Investigator: Craig Selzman, MD
Contact: 801-581-5311
craig.selzman@hsc.utah.edu
Craig Selzman, MD
8015815311
craig.selzman@hsc.utah.edu
Alyssa Messina, MA
8015853752
alyssa.messina@hsc.utah.edu
Craig Selzman, MD, Principal Investigator
University of Utah