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

SARS CoV-2 Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• COVID-19
• SARS CoV-2

• NCT number: NCT04497389
• Study type: Interventional
• Source: University of Utah
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 28, 2020
• Completion date: February 15, 2023