Principal Investigator: Craig Selzman
Keywords: Amniotic Fluid , COVID-19 , Cardiovascular , Infectious Disease Department: Cardiothoracic Division
IRB Number: 00132922 Co Investigator: Nathan  Hatton
Specialty: Infectious Diseases
Sub Specialties: Viral infections
Recruitment Status: Recruiting

Contact Information

Alyssa Messina

Brief Summary

The purpose of this study is to explore the effectiveness of processed human amniotic fluid (hAF) as a treatment for COVID-19. Past use of human amniotic products (i.e., membrane and fluid) has been previously 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, we hypothesize that intravenously (IV) administered processed sterile filtered amniotic fluid will reduce inflammation in COVID-19 patients, and improve secondary clinical outcomes. Specifically, we hypothesize that patients who receive IV-administered hAF will see a 50% reduction in mean C-reactive protein (CRP) levels following treatment.

Inclusion Criteria

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 at the time of study drug administration. 

Exclusion Criteria

Exclusion criteria:

1. Patients on invasive mechanical ventilation (e.g., endotracheal intubation)

2. Chronic home oxygen utilization

3. Clinically significant home use of immunosuppressive medications, including more than 20mg of steroid (i.e., prednisone) per day, monoclonal antibodies, or chemotherapy medications. Patients who are not chronically immune suppressed are eligible for participation. Patients who are prescribed steroids, including dexamethasone, for the purpose of treating COVID-19 prior to the patient’s study hospital admission will not be excluded.

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 current 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