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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04319731
Recruitment Status : Unknown
Verified April 2020 by Craig Selzman, University of Utah.
Recruitment status was:  Recruiting
First Posted : March 24, 2020
Last Update Posted : April 17, 2020
Information provided by (Responsible Party):
Craig Selzman, University of Utah

Brief Summary:
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 or disease Intervention/treatment Phase
SARS CoV-2 Infection Biological: Human Amniotic Fluid Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure
Actual Study Start Date : March 20, 2020
Estimated Primary Completion Date : March 20, 2021
Estimated Study Completion Date : March 20, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. All cause mortality [ Time Frame: Measured at day 60 or at hospital discharge, whichever comes first. ]
    Survival at day 60 or hospital discharge

  2. Systemic inflammation [ Time Frame: Measured at day 5 post enrollment. ]
    Systemic inflammation at 5 days measured by serum IL-6.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319731

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Contact: Craig Selzman, MD (801) 581-5311 craig.selzman@hsc.utah.edu
Contact: Joseph Tonna, MD (801) 581-5311 joseph.tonna@hsc.utah.edu

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United States, Utah
University of Utah Health Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Craig Selzman, MD    801-581-5311    craig.selzman@hsc.utah.edu   
Sponsors and Collaborators
University of Utah
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Principal Investigator: Craig Selzman, MD University of Utah
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Craig Selzman, Principle Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT04319731    
Other Study ID Numbers: 131618
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Craig Selzman, University of Utah:
Amniotic fluid
Respiratory failure
Critical illness
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases