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

Not Applicable

Completed

• Conditions: COVID-19
• Interventions: Procedure: Extracorporeal photopheresis

• Registration Number: NCT05882331
• Lead Sponsor: Del-Pest Central Hospital - National Institute of Hematology and Infectious Diseases

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.

Detailed 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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2023-05-25
• Study First Submitted QC: 2023-05-28
• Study First Posted: 2023-05-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Primary Completion: 2024-08-06
• Study Completion: 2024-08-06
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Clinical outcomes	All outcomes are assessed at EOT+28 days and compared to data at inclusion.	Clinical outcomes are all-cause death, invasive mechanical ventilation and ICU admittance requirement.
Virological outcomes	All outcomes are assessed at EOT+28 days and compared to data at inclusion.	Virological outcomes are respiratory and blood SARS-CoV-2 RT-PCR positivity.
Radiological outcomes	All outcomes are assessed at EOT+28 days and compared to data at inclusion.	Radiological outcomes are radiological progression/regression or fixed infiltration on chest CT scan.

Trial Locations

Locations (1)

South Pest Central Hospital, National Institute of Haematology and Infectious Diseases; 🇭🇺 Budapest, Hungary