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

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

Detailed Description
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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.

Official Title
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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

Conditions
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SARS CoV-2

Intervention / Treatment
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* Biological: Human Amniotic Fluid


Participation Criteria
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Eligibility Criteria
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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 investigational product (IP) 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) 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 Patients on >12 liters per minute via non-rebreather (NRB) or >80% oxygen via high flow nasal cannula 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 Patients diagnosed with Stage 4 or 5 chronic kidney disease (CKD) Patients with diagnosed New York Heart Association (NYHA) class 4 or 5 congestive heart failure Patients with a left ventricular assist device (LVAD) Patients with thromboembolic phenomena Patients with Type 2 and above heart block Patients with established positive bacterial blood cultures prior to enrollment Patients with ongoing pericardial effusion or ascites Patients with clinically significant arrhythmia Patients with liver function tests (ALT or AST) >3x normal Patients with untreated HIV infection Patients diagnosed with end-stage organ disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>10ml intravenous hAF QD (once daily) for 5 consecutive days | Biological: Human Amniotic Fluid<br>* Patients will receive 10ml intravenous hAF each day for 5 consecutive days.<br>|
| No Intervention: Standard of Care<br>10 mL normal saline QD (once daily) for 5 days | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive Protein | 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 | Baseline through post-treatment (6 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amniotic fluid, COVID-19