Safety and Feasibility of Amniotic Fluid as a Treatment for COVID-19 Patients
- Conditions
- SARS CoV-2
- Interventions
- Biological: Human Amniotic Fluid
- Registration Number
- NCT04497389
- Lead Sponsor
- University of Utah
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Human Amniotic Fluid 10ml intravenous hAF QD (once daily) for 5 consecutive days
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Utah Health
🇺🇸Salt Lake City, Utah, United States