Measurement of IL-6 and Secondary Inflammatory Markers Before and After Therapeutic Plasma Exchange (TPE) in Hospitalized Patients

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.

Study Overview

• Status: Unknown
• Conditions: COVID-19
• Intervention / Treatment: Device: Therapeutic plasma exchange

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Michael Talalaev, D.O.; Phone Number: 305-284-7500; Email: MTalalaev@larkinhospital.com

Study Locations

• United States
  • Florida
    • South Miami, Florida, United States, 33143
      • Recruiting
      • Larkin Community Hospital
      • Contact: Michael Talalaev, D.O.; Phone Number: 305-284-7500; Email: MTalalaev@larkinhospital.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with moderate-severe COVID-19 infection including early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS)
2. Able to provide Informed Consent signed by the subject or by the subject's legal or healthcare proxy.
3. Admitted to the participating facilities as listed above (Larkin South Miami Hospital, Larkin Palm Springs Hospital).
4. Subjects between 18 and 69 years of age.
5. If female, subjects that have a negative result in a quantitative b-HCG blood test if they are within reproductive age.
6. A positive COVID-19 test via nasopharyngeal swab RT-PCR.
7. Agree to not participate in another clinical trial during the study period.

Exclusion Criteria:

1. Under 18 years of age or older than 69 years of age.

2. 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;

3. Life-threatening disease, defined as:

   i. respiratory failure ii. septic shock, and/or iii. multiple organ dysfunction or failure

4. Unable to provide informed consent or decline to consent.
5. Sequential Organ Failure Assessment (SOFA) score of 12 or above.
6. Hemodynamic instability, sepsis, or other conditions causing inability to tolerate fluid shifts
7. Inability to tolerate central line placement
8. Allergy to FFP or albumin
9. Severe hypocalcemia
10. Patients with heparin allergies should not receive heparin as an anticoagulant during plasmapheresis
11. Patients taking angiotensin-converting enzyme (ACE) inhibitors are advised to stop taking the medication for at least 24 hours before starting plasmapheresis
12. Active or recent bleeding (unless controlled for >48 hours).
13. Thrombocytopenia (≤25,000/L).
14. Advanced cirrhosis with a history of esophageal varices.
15. Chronic kidney disease requiring hemodialysis.
16. Active solid or non-solid malignancy or Lymphoma within the last 2 years.
17. Heart failure (NYHA class III or IV).
18. HIV infection (AIDS criteria), a history of immunodeficiency, or subject is currently receiving immunosuppressive therapy.
19. Women of childbearing age who are pregnant or intend to become pregnant during the study period.
20. Known history of chromosomal or genetic abnormalities.
21. History of hypersensitivity or any kind of adverse reaction to blood products.
22. Contraindication to transfusion of blood products, or refusal due to religious/personal reasons.
23. Any kind of drug or alcohol dependence that would interfere with adherence to the study requirements.
24. Already part of this trial, recruited at a different hospital.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Therapeutic plasma exchange

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	60 days

Collaborators and Investigators

• Sponsor: Larkin Community Hospital
• Investigators: Principal Investigator: Michael Talalaev, D.O., Larkin Community Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2020
• Primary Completion (Anticipated): August 30, 2021
• Study Completion (Anticipated): August 30, 2021

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 15, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: therapeutic plasma exchange; covid19; coronavirus
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: LCH-1-092020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes