Measurement of IL-6 and Secondary Inflammatory Markers Before and After Therapeutic Plasma Exchange (TPE) in Hospitalized Patients
NCT04592705 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2020-10-19
Summary
Given the current lack of an effective drug or therapy, a clinical trial to better understand the safety and efficacy of therapeutic plasma exchange (TPE) in COVID-19 patients is urgently needed. The goal of this trial is to study the efficacy and safety of TPE therapy in subjects with moderate to severe COVID-19 by determining the morbidity and mortality after TPE therapy.
Conditions
Interventions
- DEVICE
-
Therapeutic plasma exchange
TPE is the process of plasmapheresis, an invasive procedure separating plasma from red blood cells using centrifuge-based devices. Filtration involves the insertion of a central venous catheter in the internal jugular, femoral or subclavian vein after which blood is drawn from the patient's circulation and transferred to a filter that separates the plasma from blood cells. Thereafter, the plasma extracted is substituted with human albumin and/or FFP.
Sponsors & Collaborators
-
Larkin Community Hospital
lead OTHER
Principal Investigators
-
Michael Talalaev, D.O. · Larkin Community Hospital
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 69 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-11
- Primary Completion
- 2021-08-30
- Completion
- 2021-08-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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