Safety and Feasibility of Amniotic Fluid as a Treatment for COVID-19 Patients

Utah System of Higher Education (USHE)

Status and phase: Completed; Phase 2; Phase 1

Conditions: SARS CoV-2

Treatments: Biological: Human Amniotic Fluid

Study type: Interventional

Funder types: Other

Identifiers

NCT04497389

132922

Details and patient eligibility

About

The purpose of this study is to explore the effectiveness of processed human amniotic fluid as a treatment for COVID-19.

Full 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 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.

Data sharing: Trial results will be published in peer reviewed publications upon completion of analysis.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 investigational product (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 New York Heart Association (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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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47 participants in 2 patient groups

Intervention

Experimental group

Description:

10ml intravenous hAF QD (once daily) for 5 consecutive days

Treatment:

Biological: Human Amniotic Fluid

Standard of Care

No Intervention group

Description:

10 mL normal saline QD (once daily) for 5 days