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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Administration of amniotic fluid in SARS-CoV-2 positive patients
University of Utah Health
Salt Lake City, Utah, United States
Ventilator Free Days
Days alive and off mechanical ventilation at day 60. Measured only among patients who receive invasive mechanical ventilation.
Time frame: Measured from hospital admission day 60 after admission.
Duration of supplemental oxygen use
Duration from hospital admission until cessation of supplemental oxygen use. Measured only among patients who do not receive invasive mechanical ventilation.
Time frame: Measured from hospital admission to day 60.
All cause mortality
Survival at day 60 or hospital discharge
Time frame: Measured at day 60 or at hospital discharge, whichever comes first.
Systemic inflammation
Systemic inflammation at 5 days measured by serum IL-6.
Time frame: Measured at day 5 post enrollment.
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