A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure
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|ClinicalTrials.gov Identifier: NCT04319731|
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : April 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|SARS CoV-2 Infection||Biological: Human Amniotic Fluid||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure|
|Actual Study Start Date :||March 20, 2020|
|Estimated Primary Completion Date :||March 20, 2021|
|Estimated Study Completion Date :||March 20, 2021|
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
- 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.
- 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.
- All cause mortality [ Time Frame: Measured at day 60 or at hospital discharge, whichever comes first. ]Survival at day 60 or hospital discharge
- Systemic inflammation [ Time Frame: Measured at day 5 post enrollment. ]Systemic inflammation at 5 days measured by serum IL-6.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319731
|Contact: Craig Selzman, MD||(801) email@example.com|
|Contact: Joseph Tonna, MD||(801) firstname.lastname@example.org|
|United States, Utah|
|University of Utah Health||Recruiting|
|Salt Lake City, Utah, United States, 84132|
|Contact: Craig Selzman, MD 801-581-5311 email@example.com|
|Principal Investigator:||Craig Selzman, MD||University of Utah|