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

Early Phase 1

Completed

• Conditions: SARS CoV-2 Infection
• Interventions: Biological: Human Amniotic Fluid

• Registration Number: NCT04319731
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-20
• Study First Submitted: 2020-03-22
• Study First Submitted QC: 2020-03-22
• Study First Posted: 2020-03-24
• Status Verified: 2020-04
• Primary Completion: 2020-06-09
• Study Completion: 2020-06-09
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Human Amniotic Fluid	Treatment groups: 1. Acute care and ICU - 10mL intravenous amniotic fluid every 24 hours for 5 days (6mL)

Primary Outcome Measures

Name	Time	Method
Ventilator Free Days	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	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

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

Trial Locations

Locations (1)

University of Utah Health; 🇺🇸 Salt Lake City, Utah, United States