Back to resultsA Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure
Primary Purpose
SARS CoV-2 Infection
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Human Amniotic Fluid
Sponsored by
About this trial
This is an interventional treatment trial for SARS CoV-2 Infection focused on measuring Amniotic fluid, Respiratory failure, Critical illness
Eligibility Criteria
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
Sites / Locations
- University of Utah Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Treatment groups: 1. Acute care and ICU - 10mL intravenous amniotic fluid every 24 hours for 5 days (6mL)
Outcomes
Primary Outcome Measures
Ventilator Free Days
Days alive and off mechanical ventilation at day 60. Measured only among patients who receive invasive mechanical ventilation.
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.
Secondary Outcome Measures
All cause mortality
Survival at day 60 or hospital discharge
Systemic inflammation
Systemic inflammation at 5 days measured by serum IL-6.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04319731
Brief Title
A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure
Official Title
A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 20, 2020 (Actual)
Primary Completion Date
June 9, 2020 (Actual)
Study Completion Date
June 9, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS CoV-2 Infection
Keywords
Amniotic fluid, Respiratory failure, Critical illness
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Treatment groups:
1. Acute care and ICU - 10mL intravenous amniotic fluid every 24 hours for 5 days (6mL)
Intervention Type
Biological
Intervention Name(s)
Human Amniotic Fluid
Intervention Description
Administration of amniotic fluid in SARS-CoV-2 positive patients
Primary Outcome Measure Information:
Title
Ventilator Free Days
Description
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.
Title
Duration of supplemental oxygen use
Description
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.
Secondary Outcome Measure Information:
Title
All cause mortality
Description
Survival at day 60 or hospital discharge
Time Frame
Measured at day 60 or at hospital discharge, whichever comes first.
Title
Systemic inflammation
Description
Systemic inflammation at 5 days measured by serum IL-6.
Time Frame
Measured at day 5 post enrollment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Selzman, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah Health
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33482902
Citation
Selzman CH, Tonna JE, Pierce J, Vargas C, Skidmore C, Lewis G, Hatton ND, Phillips JD. A pilot trial of human amniotic fluid for the treatment of COVID-19. BMC Res Notes. 2021 Jan 22;14(1):32. doi: 10.1186/s13104-021-05443-9.
Results Reference
derived
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A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure
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