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

SARS CoV-2 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04319731
• Other study ID #: 131618
• Status: Completed
• Phase: Early Phase 1
• Start date: March 20, 2020
• Est. completion date: June 9, 2020

Study information

• Verified date: April 2020
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 9, 2020
• Est. primary completion date: June 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Respiratory Insufficiency
• SARS CoV-2 Infection

Intervention

Biological:
• Human Amniotic Fluid
Administration of amniotic fluid in SARS-CoV-2 positive patients

Locations

Country	Name	City	State
United States	University of Utah Health	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator Free Days	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.
Primary	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.	Measured from hospital admission to day 60.
Secondary	All cause mortality	Survival at day 60 or hospital discharge	Measured at day 60 or at hospital discharge, whichever comes first.
Secondary	Systemic inflammation	Systemic inflammation at 5 days measured by serum IL-6.	Measured at day 5 post enrollment.