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

NCT04592705 | Unknown Phase 1 FDA Device

• 1 other identifier: LCH-1-092020
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

therapeutic plasma exchange; covid19; coronavirus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Therapeutic plasma exchange

EXPERIMENTAL

Device: Therapeutic plasma exchange

Interventions

Therapeutic plasma exchange DEVICE

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.

Therapeutic plasma exchange

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Larkin Community Hospital: lead

Study Sites (1)

Larkin Community Hospital

South Miami, Florida, 33143, United States

RECRUITING

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Plasma Exchange

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Michael Talalaev, D.O.

  Larkin Community Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Talalaev, D.O.

CONTACT

305-284-7500; MTalalaev@larkinhospital.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 19, 2020
• Study Start: September 11, 2020
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

US (1)