Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 1. Age ≥18 - 2. Hospitalized and symptomatic (cough, fevers, SOB, or sputum production) - 3. SARS CoV-2 laboratory positive obtained within 14 days of enrollment

Exclusion Criteria

  • 1. None

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment 		Treatment groups: 1. Acute care and ICU - 10mL intravenous amniotic fluid every 24 hours for 5 days (6mL)
  • Biological: Human Amniotic Fluid
    Administration of amniotic fluid in SARS-CoV-2 positive patients

Recruiting Locations

More Details

NCT ID
NCT04319731
Status
Completed
Sponsor
University of Utah

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.