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

NCT04319731 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 131618
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS CoV-2 Infection

Keywords

Amniotic fluid; Respiratory failure; Critical illness

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (2)

• All cause mortality

  Measured at day 60 or at hospital discharge, whichever comes first.

• Systemic inflammation

  Measured at day 5 post enrollment.

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment groups: 1\. Acute care and ICU - 10mL intravenous amniotic fluid every 24 hours for 5 days (6mL)

Biological: Human Amniotic Fluid

Interventions

Human Amniotic Fluid BIOLOGICAL

Administration of amniotic fluid in SARS-CoV-2 positive patients

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. None

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Health

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

• 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.

  PMID: 33482902 DERIVED

MeSH Terms

Conditions

COVID-19; Respiratory Insufficiency; Critical Illness

Interventions

amniotic fluid peptide-1, human

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Craig Selzman, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2020
• First Posted: March 24, 2020
• Study Start: March 20, 2020
• Primary Completion: June 9, 2020
• Study Completion: June 9, 2020
• Last Updated: April 24, 2023

Record last verified: 2020-04

Locations

US (1)