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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04319731

Enrollment

Registered

2020-03-24

Start date

2020-03-20

Completion date

2020-06-09

Last updated

2023-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS CoV-2 Infection

Keywords

Amniotic fluid, Respiratory failure, Critical illness

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.

Interventions

BIOLOGICALHuman Amniotic Fluid

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026