Measurement of IL-6 and Secondary Inflammatory Markers Before and After Therapeutic Plasma Exchange (TPE) in Hospitalized Patients
Primary Purpose
COVID-19
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Therapeutic plasma exchange
Sponsored by
About this trial
This is an interventional device feasibility trial for COVID-19 focused on measuring therapeutic plasma exchange, covid19, coronavirus
Eligibility Criteria
Inclusion Criteria:
- Patients with moderate-severe COVID-19 infection including early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS)
- Able to provide Informed Consent signed by the subject or by the subject's legal or healthcare proxy.
- Admitted to the participating facilities as listed above (Larkin South Miami Hospital, Larkin Palm Springs Hospital).
- Subjects between 18 and 69 years of age.
- If female, subjects that have a negative result in a quantitative b-HCG blood test if they are within reproductive age.
- A positive COVID-19 test via nasopharyngeal swab RT-PCR.
- Agree to not participate in another clinical trial during the study period.
Exclusion Criteria:
- Under 18 years of age or older than 69 years of age.
Severe disease, defined as:
i. dyspnea ii. respiratory frequency ≥ 30/min iii. blood oxygen saturation ≤ 93% iv. partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or v. lung infiltrates > 50% within 24 to 48 hours;
Life-threatening disease, defined as:
i. respiratory failure ii. septic shock, and/or iii. multiple organ dysfunction or failure
- Unable to provide informed consent or decline to consent.
- Sequential Organ Failure Assessment (SOFA) score of 12 or above.
- Hemodynamic instability, sepsis, or other conditions causing inability to tolerate fluid shifts
- Inability to tolerate central line placement
- Allergy to FFP or albumin
- Severe hypocalcemia
- Patients with heparin allergies should not receive heparin as an anticoagulant during plasmapheresis
- Patients taking angiotensin-converting enzyme (ACE) inhibitors are advised to stop taking the medication for at least 24 hours before starting plasmapheresis
- Active or recent bleeding (unless controlled for >48 hours).
- Thrombocytopenia (≤25,000/L).
- Advanced cirrhosis with a history of esophageal varices.
- Chronic kidney disease requiring hemodialysis.
- Active solid or non-solid malignancy or Lymphoma within the last 2 years.
- Heart failure (NYHA class III or IV).
- HIV infection (AIDS criteria), a history of immunodeficiency, or subject is currently receiving immunosuppressive therapy.
- Women of childbearing age who are pregnant or intend to become pregnant during the study period.
- Known history of chromosomal or genetic abnormalities.
- History of hypersensitivity or any kind of adverse reaction to blood products.
- Contraindication to transfusion of blood products, or refusal due to religious/personal reasons.
- Any kind of drug or alcohol dependence that would interfere with adherence to the study requirements.
- Already part of this trial, recruited at a different hospital.
Sites / Locations
- Larkin Community HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Therapeutic plasma exchange
Arm Description
Outcomes
Primary Outcome Measures
Time to clinical status downgrade or discharge.
Clinical improvement will be defined as a point reduction in subjects' clinical status on the 8-point WHO ordinal scale for clinical improvement or discharge from the hospital, whichever comes first.
Secondary Outcome Measures
Full Information
NCT ID
NCT04592705
First Posted
October 7, 2020
Last Updated
October 15, 2020
Sponsor
Larkin Community Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04592705
Brief Title
Measurement of IL-6 and Secondary Inflammatory Markers Before and After Therapeutic Plasma Exchange (TPE) in Hospitalized Patients
Official Title
Measurement of IL-6 and Secondary Inflammatory Markers Before and After Therapeutic Plasma Exchange (TPE) in Hospitalized Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 11, 2020 (Actual)
Primary Completion Date
August 30, 2021 (Anticipated)
Study Completion Date
August 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Larkin Community Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
therapeutic plasma exchange, covid19, coronavirus
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Therapeutic plasma exchange
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Therapeutic plasma exchange
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to clinical status downgrade or discharge.
Description
Clinical improvement will be defined as a point reduction in subjects' clinical status on the 8-point WHO ordinal scale for clinical improvement or discharge from the hospital, whichever comes first.
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with moderate-severe COVID-19 infection including early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS)
Able to provide Informed Consent signed by the subject or by the subject's legal or healthcare proxy.
Admitted to the participating facilities as listed above (Larkin South Miami Hospital, Larkin Palm Springs Hospital).
Subjects between 18 and 69 years of age.
If female, subjects that have a negative result in a quantitative b-HCG blood test if they are within reproductive age.
A positive COVID-19 test via nasopharyngeal swab RT-PCR.
Agree to not participate in another clinical trial during the study period.
Exclusion Criteria:
Under 18 years of age or older than 69 years of age.
Severe disease, defined as:
i. dyspnea ii. respiratory frequency ≥ 30/min iii. blood oxygen saturation ≤ 93% iv. partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or v. lung infiltrates > 50% within 24 to 48 hours;
Life-threatening disease, defined as:
i. respiratory failure ii. septic shock, and/or iii. multiple organ dysfunction or failure
Unable to provide informed consent or decline to consent.
Sequential Organ Failure Assessment (SOFA) score of 12 or above.
Hemodynamic instability, sepsis, or other conditions causing inability to tolerate fluid shifts
Inability to tolerate central line placement
Allergy to FFP or albumin
Severe hypocalcemia
Patients with heparin allergies should not receive heparin as an anticoagulant during plasmapheresis
Patients taking angiotensin-converting enzyme (ACE) inhibitors are advised to stop taking the medication for at least 24 hours before starting plasmapheresis
Active or recent bleeding (unless controlled for >48 hours).
Thrombocytopenia (≤25,000/L).
Advanced cirrhosis with a history of esophageal varices.
Chronic kidney disease requiring hemodialysis.
Active solid or non-solid malignancy or Lymphoma within the last 2 years.
Heart failure (NYHA class III or IV).
HIV infection (AIDS criteria), a history of immunodeficiency, or subject is currently receiving immunosuppressive therapy.
Women of childbearing age who are pregnant or intend to become pregnant during the study period.
Known history of chromosomal or genetic abnormalities.
History of hypersensitivity or any kind of adverse reaction to blood products.
Contraindication to transfusion of blood products, or refusal due to religious/personal reasons.
Any kind of drug or alcohol dependence that would interfere with adherence to the study requirements.
Already part of this trial, recruited at a different hospital.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Talalaev, D.O.
Phone
305-284-7500
Email
MTalalaev@larkinhospital.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Talalaev, D.O.
Organizational Affiliation
Larkin Community Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Larkin Community Hospital
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Talalaev, D.O.
Phone
305-284-7500
Email
MTalalaev@larkinhospital.com
12. IPD Sharing Statement
Learn more about this trial
Measurement of IL-6 and Secondary Inflammatory Markers Before and After Therapeutic Plasma Exchange (TPE) in Hospitalized Patients
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