Clinical trial NCT04497389: Safety and Feasibility of Amniotic Fluid as a Treatment for COVID-19 Patients
Official title: A Phase I/II Randomized Double-blinded Placebo-controlled Clinical Trial to Determine Safety and Feasibility of Using an Acellular Sterile Filtered Amniotic Fluid as a Treatment for COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: SARS CoV-2
Keywords: Amniotic fluid
COVID-19
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: C-reactive Protein
timeFrame: Baseline through post-treatment (6 days)
Secondary outcomes:
Other outcomes:
measure: Death Within 30 Days
timeFrame: Baseline through 30 days
measure: Any ICU Admission
timeFrame: Baseline through 30 days
measure: Hospital Length of Stay
timeFrame: From date of hospital admission through date of discharge or death, whichever comes first (up to 100 days)
measure: Need for Invasive Mechanical Ventilation
timeFrame: From date of enrollment through date of discharge or death, whichever comes first (up to 100 days)
measure: Biomarker Levels (Interleukin-6)
timeFrame: Baseline through post-treatment (6 days)
measure: Biomarker Levels (D-dimer)
timeFrame: Baseline through post-treatment (6 days)
measure: Biomarker Levels (Lactate Dehydrogenase)
timeFrame: Baseline through post-treatment (6 days)
measure: Need for ECMO
timeFrame: From date of enrollment through date of discharge or death, whichever comes first (up to 100 days)
measure: Major Adverse Cardiac Events
timeFrame: From date of enrollment through date of discharge or death, whichever comes first (up to 100 days)
measure: Patient-reported Functional Status at 1 Month
timeFrame: 1 month post-discharge
measure: Patient-reported Functional Status at 3 Months
timeFrame: 3 months post-discharge
measure: Patient-reported Functional Status at 6 Months
timeFrame: 6 months post-discharge
measure: Patient-reported Functional Status at 12 Months
timeFrame: 12 months post-discharge
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
Study officials:
affiliation: University of Utah
name: Craig Selzman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.