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.
- Study Type: Interventional
- Study Design
- Allocation: N/A
- 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: 1. Acute care and ICU – 10mL 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. None
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
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