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

April 20, 2023 updated by: University of Utah
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured from hospital admission day 60 after admission.
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.
Measured from hospital admission to day 60.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality
Time Frame: Measured at day 60 or at hospital discharge, whichever comes first.
Survival at day 60 or hospital discharge
Measured at day 60 or at hospital discharge, whichever comes first.
Systemic inflammation
Time Frame: Measured at day 5 post enrollment.
Systemic inflammation at 5 days measured by serum IL-6.
Measured at day 5 post enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: Craig Selzman, MD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2020

Primary Completion (Actual)

June 9, 2020

Study Completion (Actual)

June 9, 2020

Study Registration Dates

First Submitted

March 22, 2020

First Submitted That Met QC Criteria

March 22, 2020

First Posted (Actual)

March 24, 2020

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 20, 2023

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 131618

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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