NCT04497389

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

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• SARS CoV-2

Interventions

Type	Name	Description
BIOLOGICAL	Human Amniotic Fluid	Patients will receive 10ml intravenous hAF each day for 5 consecutive days.

Timeline

• Start date: 2020-10-28
• Primary completion: 2022-08-02
• Completion: 2023-02-15
• First posted: 2020-08-04
• Last updated: 2023-12-21
• Results posted: 2023-12-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study