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

COVID-19 Clinical Trial

— COVID-ECP  

Official title:

Extracorporeal Photopheresis as a Possible Therapeutic Approach to Adults With Severe and Critical COVID-19 Non-responsive to Remdesivir, Dexamethasone and Pharmacological Immunomodulation: an Investigational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05882331
• Other study ID #: COVID-ECP
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Del-Pest Central Hospital - National Institute of Hematology and Infectious Diseases
• Contact: Balint G Szabo, M.D., Ph.D
• Phone: +36306445976
• Email: szabo.balint.gergely[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A prospective, single-center investigational study is olanned to be performed at a tertiary referral center for COVID-19. Patients with COVID-19 are screened, and severe or critical COVID-19 cases fulfilling pre-defined clinical and biochemical criteria of non-response for >5 days despite remdesivir, dexamethasone and immunomodulation (tocilizumab, baricitinib, ruxolitinib) are consecutively enrolled. After inclusion, two ECP sessions on two consecutive days per week for 2 weeks are applied. Patients are followed up per protocol from study inclusion, and clinical, virological and radiological outcomes are assessed at end-of-treatment (EOT)+28 days.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Hospitalized adult (=18 years at diagnosis) patients with diagnosed COVID-19 of any illness duration are eligible, and screened for inclusion during daily on-site investigator visits. Patients are consecutively enrolled.

Inclusion criteria:

1. severe or critical COVID-19,

2. 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.

Exclusion criteria:

1. pregnancy or breastfeeding,

2. allergy or contraindications to 8-methoxypsoralen,

3. pre-COVID-19 ECP,

4. written informed consent was not obtainable.

Clinical non-response is defined when =2 of the following are met, compared to baseline:

1. persistent fever (non-contact tympanal measurement of >38.0°C) for =48 hours, despite antipyretics,

2. persistent or failing COVID-19 severity, according to World Health Organization criteria, by =1 stratum after =48 hours,

3. persistent or failing partial arterial oxygen tension (PaO2) / inspired oxygen fraction (FiO2), by =10% after =48 hours, despite respiratory support,

4. radiological progression by infiltrate extension on chest computed tomography (CT), by =10% after =48 hours,

5. 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:

1. serum lactate dehydrogenase (LDH),

2. serum C-reactive protein (CRP),

3. serum ferritin

4. plasma interleukin-6 (IL-6),

5. D-dimer.

Related Conditions & MeSH terms

• COVID-19

Intervention

Procedure:
• Extracorporeal photopheresis
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.

Locations

Country	Name	City	State
Hungary	South Pest Central Hospital, National Institute of Haematology and Infectious Diseases	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Del-Pest Central Hospital - National Institute of Hematology and Infectious Diseases

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.

External Links

•   Study website