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

Overview

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

  • 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

Interventions

  • 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

Primary 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.

Secondary Measures

  • 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

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • 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, craig.selzman@hsc.utah.edu

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