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Completed

NCT Number: NCT04319731

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

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.

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Key information

Conditions

SARS CoV-2 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Critical Illness Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Utah Health

Salt Lake City, Utah, 84132, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Human Amniotic Fluid

Biological

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. All cause mortality

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

    Survival at day 60 or hospital discharge

  2. Systemic inflammation

    Time frame: Measured at day 5 post enrollment.

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

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 24, 2020
Registry last updated
Apr 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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