A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure
NCT04319731 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2023-04-24
Summary
The purpose of this study is to test the effect of purified (acellular) amniotic fluid as a treatment for SARS CoV-2 (COVID19)-associated respiratory failure. Past use of human amniotic products (i.e., membrane and fluid) is FDA-approved for tissue injury and has been used to reduce inflammation and fibrosis in patients with a variety of medical conditions. The investigators hypothesize that using nebulized and/or intravenous purified (acellular) amniotic fluid will reduce both inflammation in patients hospitalized for in SARS CoV-2 (COVID19)-associated respiratory failure, potentially leading to a decrease in respiratory support.
Conditions
- SARS CoV-2 Infection
Interventions
- BIOLOGICAL
-
Human Amniotic Fluid
Administration of amniotic fluid in SARS-CoV-2 positive patients
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Craig Selzman, MD · University of Utah
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-03-20
- Primary Completion
- 2020-06-09
- Completion
- 2020-06-09
- FDA Drug
- Yes
Countries
- United States
Study Locations
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