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. We 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.
- Study Type: Interventional
- Study Design
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: March 20, 2021
- Biological: Human Amniotic Fluid
- Administration of amniotic fluid in SARS-CoV-2 positive patients
Arms, Groups and Cohorts
- Experimental: Treatment
- Treatment groups: Acute care – Nebulized amniotic fluid every 24 hours for 5 days (3mL) ICU – Nebulized amniotic fluid every 24 hours for 5 days (3mL) plus intravenous amniotic fluid every 24 hours for 5 days (6mL)
Clinical Trial Outcome Measures
- Ventilator Free Days
- Time Frame: Measured from hospital admission day 60 after admission.
- Days alive and off mechanical ventilation at day 60. Measured only among patients who receive invasive mechanical ventilation.
- Duration of supplemental oxygen use
- Time Frame: Measured from hospital admission to day 60.
- Duration from hospital admission until cessation of supplemental oxygen use. Measured only among patients who do not receive invasive mechanical ventilation.
- All cause mortality
- Time Frame: Measured at day 60 or at hospital discharge, whichever comes first.
- Survival at day 60 or hospital discharge
- Systemic inflammation
- Time Frame: Measured at day 5 post enrollment.
- Systemic inflammation at 5 days measured by serum IL-6.
Participating in This Clinical Trial
- 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
- 1. Home oxygen use
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University of Utah
- Provider of Information About this Clinical Study
- Principal Investigator: Craig Selzman, Principle Investigator – University of Utah
- Overall Official(s)
- Craig Selzman, MD, Principal Investigator, University of Utah
- Overall Contact(s)
- Craig Selzman, MD, (801) 581-5311, firstname.lastname@example.org
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.