Safety and Feasibility of Amniotic Fluid as a Treatment for COVID-19 Patients
Study Details
Study Description
Brief Summary
The purpose of this study is to explore the effectiveness of processed human amniotic fluid as a treatment for COVID-19.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention 10ml intravenous hAF QD for 5 consecutive days |
Biological: Human Amniotic Fluid
Patients will receive 10ml intravenous hAF each day for 5 consecutive days.
|
| No Intervention: Standard of Care 10 mL normal saline QD for 5 days |
Outcome Measures
Primary Outcome Measures
- C-reactive protein [Baseline through post-treatment (6 days)]
Assess reduction of inflammation in COVID-19 patients, potentially leading to a decrease in the need for critical care. This will be assessed by measurement of C-reactive protein levels before and after the intervention. Units: mg/dL
Other Outcome Measures
- Death within 30 Days [Baseline through 30 days]
Comparison of mortality between intervention and control groups
- ICU-free days at 30 days [Baseline through 30 days]
Comparison of days spend in ICU between intervention and control groups
- Hospital length of stay [From date of hospital admission through date of discharge or death, whichever comes first (up to 100 days)]
Comparison of days spent in hospital between intervention and control groups
- Need for invasive mechanical ventilation [From date of enrollment through date of discharge or death, whichever comes first (up to 100 days)]
Comparison of mechanical ventilation incidence between intervention and control groups
- Biomarker levels (interleukin-6) [Baseline through post-treatment (6 days)]
Comparison of mean biomarker level change between intervention and control groups. Units: pg/mL
- Biomarker levels (d-dimer) [Baseline through post-treatment (6 days)]
Comparison of mean biomarker level change between intervention and control groups. Units: ug/mL
- Biomarker levels (lactate dehydrogenase) [Baseline through post-treatment (6 days)]
Comparison of mean biomarker level change between intervention and control groups. Units: u/L
- Need for ECMO [From date of enrollment through date of discharge or death, whichever comes first (up to 100 days)]
Comparison of ECMO incidence between intervention and control groups
- Major adverse cardiac events [From date of enrollment through date of discharge or death, whichever comes first (up to 100 days)]
Compare frequency of major adverse cardiac events (MACE) between intervention and control groups
- Patient-reported functional status [Administered at 1, 3, 6, and 12 months post discharge (1 year)]
Comparison of PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire results on a computer-adaptive platform between intervention and control groups using T-scores. Scale mean = 50, standard deviation = 10.
- PTSD Checklist [Administered at 1, 3, 6, and 12 months post discharge (1 year)]
Patients will be administered a 20-question self-report measure of PTSD symptoms. Total scores range from 0-80. Scores of 31-33 or above generally indicate clinically likely PTSD.
Eligibility Criteria
Criteria
Inclusion criteria:
-
Age >18
-
SARS CoV-2 laboratory positive test, obtained within 14 days of enrollment
-
Hospitalized
-
COVID-19 symptomatic (cough, fevers, shortness of breath, and/or sputum production)
-
Has a room air pulse oximetry of ≤94% and requires supplemental oxygen therapy
-
Patients of childbearing potential who agree to use acceptable methods of contraception for 90 days after last administration of study IP
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Patients who are receiving standard of care therapies for COVID-19 that are not FDA approved are eligible for this study
-
Subjects must be able to consent to the study (i.e., Glasgow Coma Scale score of ≥14)
-
Patients are required to have controlled blood pressure of <160/96 and a pulse of <110.
Exclusion criteria:
-
Patients on invasive mechanical ventilation (e.g., endotracheal intubation)
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Chronic home oxygen utilization
-
Home or current use of immunosuppressive medications (including steroids)
-
Women who are pregnant, breastfeeding, or become pregnant during the study
-
Patients on non-invasive positive pressure ventilation
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Patients on >12 liters per minute via non-rebreather (NRB) or >80% oxygen via high flow nasal cannula
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Patients who, in the opinion of the PI, have impending respiratory failure, defined as requiring rapidly escalating oxygen supplementation
-
Patients with a hemoglobin <9 mg/dL
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Patients diagnosed with Stage 4 or 5 chronic kidney disease (CKD)
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Patients with diagnosed NYHA class 4 or 5 congestive heart failure
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Patients with a left ventricular assist device (LVAD)
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Patients with thromboembolic phenomena
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Patients with Type 2 and above heart block
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Patients with established positive bacterial blood cultures prior to enrollment
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Patients with ongoing pericardial effusion or ascites
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Patients with clinically significant arrhythmia
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Patients with liver function tests (ALT or AST) >3x normal
-
Patients with untreated HIV infection
-
Patients diagnosed with end-stage organ disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Utah Health | Salt Lake City | Utah | United States | 84132 |
Sponsors and Collaborators
- University of Utah
Investigators
- Principal Investigator: Craig Selzman, MD, University of Utah
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 132922