Extracorporeal Photopheresis as a Possible Therapeutic Approach to Adults With Severe and Critical COVID-19

NCT05882331 | Completed

• 1 other identifier: COVID-ECP
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Optimal approach for adult patients hospitalized with severe and critical COVID-19 non-responsive to antiviral and immunomodulatory drugs is not well established. The study aim is to evaluate feasibility and safety of extracorporeal photopheresis (ECP) in this setting.

Conditions

COVID-19

Keywords

COVID-19

Outcome Measures

Primary Outcomes (3)

• Clinical outcomes

  Clinical outcomes are all-cause death, invasive mechanical ventilation and ICU admittance requirement.

  All outcomes are assessed at EOT+28 days and compared to data at inclusion.

• Virological outcomes

  Virological outcomes are respiratory and blood SARS-CoV-2 RT-PCR positivity.

  All outcomes are assessed at EOT+28 days and compared to data at inclusion.

• Radiological outcomes

  Radiological outcomes are radiological progression/regression or fixed infiltration on chest CT scan.

  All outcomes are assessed at EOT+28 days and compared to data at inclusion.

Study Arms (1)

Extracorporeal photopheresis arm

EXPERIMENTAL

Patients will receive extracorporeal photopheresis on this arm, in conjucntion to standard COVID-19 treatments (remdesivir, dexamethasone, IL-6- and/or JAK-inhibition).

Procedure: Extracorporeal photopheresis

Interventions

Extracorporeal photopheresis PROCEDURE

ECP is initiated on study inclusion day by Therakos Cellex system, according to manufacturers' instructions. Each patient receives two ECP cycles for 2 weeks, each consisting of two sessions on consecutive days per week (alltogether four sessions), through a peripheral or central venous route. Cycles 1 and 2 are separated by 5 consecutive days. One ECP session takes \~3 hours, and is separated into 4 phases. On priming, the system performes a series of calibrations to ensure proper operation. During collection, 1500 ml of whole blood is processed to collect a concentrated buffy coat containing white blood cells, while other cells and plasma are reinfused. During the photoactive phase, a prescribed dose of 8-methoxypsoralen is added to the buffy coat, which is then circulated through ultraviolet-A photoactivation. During reinfusion phase, treated cells are automatically reinfused to the patient.

Also known as: Therakos Cellex system

Extracorporeal photopheresis arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• severe or critical COVID-19,
• clinical and biochemical non-response for \>5 consecutive days, despite remdesivir, dexamethasone and immunomodulatory therapies (tocilizumab, baricitinib or ruxolitinib), with or without COVID-19 reconvalescent plasmatherapy, in absence of other causes.

You may not qualify if:

• pregnancy or breastfeeding,
• allergy or contraindications to 8-methoxypsoralen,
• pre-COVID-19 ECP,
• written informed consent was not obtainable.
• Clinical non-response is defined when ≥2 of the following are met, compared to baseline:
• persistent fever (non-contact tympanal measurement of \>38.0°C) for ≥48 hours, despite antipyretics,
• persistent or failing COVID-19 severity, according to World Health Organization criteria, by ≥1 stratum after ≥48 hours,
• persistent or failing partial arterial oxygen tension (PaO2) / inspired oxygen fraction (FiO2), by ≥10% after ≥48 hours, despite respiratory support,
• radiological progression by infiltrate extension on chest computed tomography (CT), by ≥10% after ≥48 hours,
• novel requirement of invasive mechanical ventilation, as deemed necessary by an intensive care unit (ICU) team.
• Biochemical non-response is defined when ≥2 of the following analytes show persistent or increasing levels by ≥20% after ≥48 hours, compared to baseline:
• serum lactate dehydrogenase (LDH),
• serum C-reactive protein (CRP),
• serum ferritin
• plasma interleukin-6 (IL-6),

Sponsors & Collaborators

• Del-Pest Central Hospital - National Institute of Hematology and Infectious Diseases: lead

Study Sites (1)

South Pest Central Hospital, National Institute of Haematology and Infectious Diseases

Budapest, 1097, Hungary

Location

Related Publications (1)

• Szabo BG, Remenyi P, Tasnady S, Korozs D, Gopcsa L, Reti M, Varkonyi A, Sinko J, Lakatos B, Szlavik J, Beko G, Bobek I, Valyi-Nagy I. Extracorporeal Photopheresis as a Possible Therapeutic Approach for Adults with Severe and Critical COVID-19 Non-Responsive to Standard Treatment: A Pilot Investigational Study. J Clin Med. 2023 Jul 29;12(15):5000. doi: 10.3390/jcm12155000.

  PMID: 37568402 DERIVED

Related Links

• Study website

MeSH Terms

Conditions

COVID-19

Interventions

Photopheresis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PUVA Therapy; Ultraviolet Therapy; Phototherapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Istvan Valyi-Nagy, Prof. Dr.

  South Pest Central Hospital, National Institute of Hematology and Infectious Diseases

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: ECP is initiated on study inclusion day by Therakos Cellex system, according to manufacturers' instructions. Each patient receives two ECP cycles for 2 weeks, each consisting of two sessions on consecutive days per week (alltogether four sessions), through a peripheral or central venous route. Cycles 1 and 2 are separated by 5 consecutive days. One ECP session takes \~3 hours, and is separated into 4 phases. On priming, the system performes a series of calibrations to ensure proper operation. During collection, 1500 ml of whole blood is processed to collect a concentrated buffy coat containing white blood cells, while other cells and plasma are reinfused. During the photoactive phase, a prescribed dose of 8-methoxypsoralen is added to the buffy coat, which is then circulated through ultraviolet-A photoactivation. During reinfusion phase, treated cells are automatically reinfused to the patient.

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: May 31, 2023
• Study Start: January 1, 2021
• Primary Completion: August 6, 2024
• Study Completion: August 6, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data will be available after publication of the results in peer-reviewed journals.
• Access Criteria: Anonymized, individial patient data will be available to other researchers upon reasonbla request from the principal infestigator.

Locations

HU (1)