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

• Sponsor: University of Utah (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04319731
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
SARS CoV-2 Infection	Biological: Human Amniotic Fluid	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated 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: Mar 20, 2020
• Anticipated Primary Completion Date: Mar 20, 2021
• Anticipated Study Completion Date: Mar 20, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. All cause mortality [Measured at day 60 or at hospital discharge, whichever comes first.]

   Survival at day 60 or hospital discharge

2. Systemic inflammation [Measured at day 5 post enrollment.]

   Systemic inflammation at 5 days measured by serum IL-6.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1. Age ≥18
• 1. Hospitalized and symptomatic (cough, fevers, SOB, or sputum production)
• 1. SARS CoV-2 laboratory positive obtained within 14 days of enrollment

Exclusion Criteria:

• 1. None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Utah Health	Salt Lake City	Utah	United States	84132

Sponsors and Collaborators

• University of Utah

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Craig Selzman, Principle Investigator, University of Utah
• ClinicalTrials.gov Identifier: NCT04319731
• Other Study ID Numbers: 131618
• First Posted: Mar 24, 2020
• Last Update Posted: Apr 17, 2020
• Last Verified: Apr 1, 2020

• 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, Principle Investigator, University of Utah: Amniotic fluid; Respiratory failure; Critical illness
• Additional relevant MeSH terms: COVID-19; Respiratory Insufficiency

Study Results

No Results Posted as of Apr 17, 2020