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

Status unconfirmed · Phase 1

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT04592705

Run by

Larkin Community Hospital

People needed

10

Starts

2020-09-11

Expected to finish

2021-08-30

Last updated by the study team

2020-10-19

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Larkin Community Hospital — South Miami, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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