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

NCT ID: NCT04497389

Last Updated: 2023-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-28
• Study Completion Date: 2023-02-15

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 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.

Conditions

SARS CoV-2

Keywords

Amniotic fluid; COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Human Amniotic Fluid

Intervention Type: BIOLOGICAL

Patients will receive 10ml intravenous hAF each day for 5 consecutive days.

Standard of Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Human Amniotic Fluid

Patients will receive 10ml intravenous hAF each day for 5 consecutive days.

Intervention Type: BIOLOGICAL

Eligibility 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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Craig Selzman

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Craig Selzman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah Health

Salt Lake City, Utah, United States

Countries

United States

References

Tonna JE, Pierce J, Brintz BJ, Bardsley T, Hatton N, Lewis G, Phillips JD, Skidmore CR, Selzman CH. A randomized, double-blinded, placebo-controlled clinical trial of sterile filtered human amniotic fluid for treatment of COVID-19. BMC Infect Dis. 2023 Dec 8;23(1):864. doi: 10.1186/s12879-023-08856-y.

Reference Type: DERIVED

PMID: 38066442 (View on PubMed)

Tonna JE, Pierce J, Hatton N, Lewis G, Phillips JD, Messina A, Skidmore CR, Taylor K, Selzman CH. Safety and feasibility of using acellular sterile filtered amniotic fluid as a treatment for patients with COVID-19: protocol for a randomised, double-blinded, placebo-controlled clinical trial. BMJ Open. 2021 Feb 11;11(2):e045162. doi: 10.1136/bmjopen-2020-045162.

Reference Type: DERIVED

PMID: 33574155 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

132922

Identifier Type: -

Identifier Source: org_study_id