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Methylprednisolone in Patients With Cognitive Deficits in Post-COVID-19 Syndrome (PCS) (PoCoVIT)

About

Status:
Ongoing
Principal investigator:
Country:
Germany
Study start:
2023-09-30
Completion (planned):
2025-03-30
Last update:
2024-02-06

 

Research types:
Clinical research
Research areas:
Immunological dysfunction, Nervous system disorder
Interventions:
Methylprednisolone, Placebo
Priv. Sector Partner:
Not available
Sponsors:

Project description

This randomized controlled trial aims to investigate the impact of methylprednisolone, a generally well-tolerated and affordable drug, on cognitive deficits in post-COVID Syndrome (PCS) patients (not excluding PCS ME/CFS) with suspected autoimmune involvement, as part of the clinical trials within the National Clinical Study Group (NKSG).

The objective of this two-arm, double-blind, randomized, placebo-controlled trial is to demonstrate improvement in memory satisfaction as measured by the Multifactorial Memory Questionnaire (MMQ) in patients with PCS treated with Methylprednisolone compared with placebo. Methylprednisolone is a well-known immunosuppressant used for multiple diseases of (suspected) autoimmune etiology. The study spans 52 weeks, and participants will be stratified based on age, sex, and cognitive screening using the Montreal Cognitive Assessment Scale (MoCA). They will be randomly assigned in a 1:1 ratio to receive either Methylprednisolone (including a tapering phase) or placebo for 6 weeks, followed by an additional 6 weeks of open treatment phase with Methylprednisolone after a 6-weeks treatment pause. During the study, follow-up visits will be conducted as outpatient visits in weeks 8 and 20, with a final telephone follow-up after 52 weeks. The screening and baseline examinations will involve recording of medical history, checking inclusion and exclusion criteria, and conducting clinical examinations. The intervention group will receive approximately 1mg/kg body weight oral Methylprednisolone once daily for 6 weeks, with dosage reduction after week 4. The other group will receive a matching placebo once daily for 6 weeks, following the same titration regimen to maintain blinding. The starting dose for both interventions will be Methylprednisolone at approximately 1 mg/kg body weight or matching placebo once per day. Throughout the treatment phase, all participants will undergo safety and monitoring examinations.

This clinical trial is of significant importance as it has the potential to benefit individuals with PCS by exploring the effects of Methylprednisolone on cognitive impairment and fatigue. Additionally, it may provide crucial insights into pathophysiological processes of PCS, leading to the development of more effective therapies and improved patient outcomes.

(Description adapted from clinical trial website: see link above)

Patient cohort

Post-COVID Syndrome (PCS) according to WHO, including post-COVID ME/CFS fulfilling Canadian Consensus Criteria (CCC). Comparisson of sham/placebo vs treated patients.

Patients enrolled: 418

Age group: ≥ 18 years (Adults)

Research areas (6)
Research types (1)
Research networks (1)
Working groups (1)
People (2)
Publications (0)
Organisations (1)

Research areas

Immunological dysfunction
Description:
Immune system is the body's defense mechanism against foreign organisms or substances and deviant native cells. It includes the humoral immune response and the cell-mediated response and consists of a complex of interrelated cellular, molecular, and genetic components. Diseases of the immune system are disorders caused by abnormal or absent immunologic mechanisms, whether humoral, cell-m...
Research projects:
17
Publications:
39
Nervous system disorder
Description:
Nervous system is the entire nerve apparatus, composed of a central part, the brain and spinal cord, and a peripheral part, the cranial and spinal nerves, autonomic ganglia, and plexuses. Diseases of the nervous system include diseases of the central and peripheral nervous system. This includes disorders of the brain, spinal cord, cranial nerves, peripheral nerves, nerve roots, autonomic ner...
Research projects:
5
Publications:
11