A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure

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

  • SARS CoV-2 Infection

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