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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-20

Study Completion Date

2020-06-09

Brief Summary

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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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Detailed Description

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Conditions

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SARS CoV-2 Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Treatment groups:

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

Group Type EXPERIMENTAL

Human Amniotic Fluid

Intervention Type BIOLOGICAL

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

Interventions

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Human Amniotic Fluid

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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