Evidence map›Paper›PMID 38509608›Full record

ArticleNeurological research and practice2024

Randomized controlled double-blind trial of methylprednisolone versus placebo in patients with post-COVID-19 syndrome and cognitive deficits: study protocol of the post-corona-virus immune treatment (PoCoVIT) trial.

Christiana Franke, Vanessa Raeder, Fabian Boesl, Benno Bremer, Lucas C Adam, Ameli Gerhard, Irina Eckert, Anneke Quitschau, Anne Pohrt, Susen Burock and 4 more

Abstract read
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In one paragraph

Article in Neurological research and practice, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Observational
  3. Article
  4. Review
  5. Observational
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Christiana FrankeDepartment of Neurology and Experimental Neurology, Corporate Member of Freie Universität Berlin and Humboldt Universität zu Berlin, Charité - Universitätsmedizin Berlin, Charité Campus Benjamin Franklin, Hindenburgdamm 30, 12203, Berlin, Germany. christiana.franke@charite.de.ORCID http://orcid.org/0000-0002-5609-2472
Vanessa RaederDepartment of Neurology and Experimental Neurology, Corporate Member of Freie Universität Berlin and Humboldt Universität zu Berlin, Charité - Universitätsmedizin Berlin, Charité Campus Benjamin Franklin, Hindenburgdamm 30, 12203, Berlin, Germany.
Fabian BoeslDepartment of Neurology and Experimental Neurology, Corporate Member of Freie Universität Berlin and Humboldt Universität zu Berlin, Charité - Universitätsmedizin Berlin, Charité Campus Benjamin Franklin, Hindenburgdamm 30, 12203, Berlin, Germany.
Benno BremerDepartment of Neurology and Experimental Neurology, Corporate Member of Freie Universität Berlin and Humboldt Universität zu Berlin, Charité - Universitätsmedizin Berlin, Charité Campus Benjamin Franklin, Hindenburgdamm 30, 12203, Berlin, Germany.
Lucas C AdamDepartment of Neurology and Experimental Neurology, Corporate Member of Freie Universität Berlin and Humboldt Universität zu Berlin, Charité - Universitätsmedizin Berlin, Charité Campus Benjamin Franklin, Hindenburgdamm 30, 12203, Berlin, Germany.
Ameli GerhardDepartment of Neurology and Experimental Neurology, Corporate Member of Freie Universität Berlin and Humboldt Universität zu Berlin, Charité - Universitätsmedizin Berlin, Charité Campus Benjamin Franklin, Hindenburgdamm 30, 12203, Berlin, Germany.
Irina EckertDepartment of Neurology and Experimental Neurology, Corporate Member of Freie Universität Berlin and Humboldt Universität zu Berlin, Charité - Universitätsmedizin Berlin, Charité Campus Benjamin Franklin, Hindenburgdamm 30, 12203, Berlin, Germany.
Anneke QuitschauDepartment of Neurology and Experimental Neurology, Corporate Member of Freie Universität Berlin and Humboldt Universität zu Berlin, Charité - Universitätsmedizin Berlin, Charité Campus Benjamin Franklin, Hindenburgdamm 30, 12203, Berlin, Germany.
Anne PohrtCorporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany.
Susen BurockCorporate Member of Freie Universität Berlin and Humboldt Universität zu Berlin, Clinical Trial Office, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Lisa BruckertCorporate Member of Freie Universität Berlin and Humboldt Universität zu Berlin, Clinical Trial Office, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Carmen ScheibenbogenInstitute of Medical Immunology, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Charité - Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.
Harald PrüßDepartment of Neurology, Corporate Member of Freie Universität Berlin and Humboldt Universität zu Berlin, Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany.
Heinrich J AudebertDepartment of Neurology and Experimental Neurology, Corporate Member of Freie Universität Berlin and Humboldt Universität zu Berlin, Charité - Universitätsmedizin Berlin, Charité Campus Benjamin Franklin, Hindenburgdamm 30, 12203, Berlin, Germany.

Funding

Bundesministerium für Bildung, Wissenschaft, Forschung und Technologie 01EP2201
6 · The paper itself

Abstract

introductionPost-COVID-19 Syndrome (PCS) includes neurological manifestations, especially fatigue and cognitive deficits. Immune dysregulation, autoimmunity, endothelial dysfunction, viral persistence, and viral reactivation are discussed as potential pathophysiological mechanisms. The post-corona-virus immune treatment (PoCoVIT) trial is a phase 2a randomized, controlled, double-blind trial designed to evaluate the effect of methylprednisolone versus placebo on cognitive impairment in PCS. This trial is designed based on the hypothesised autoimmunological pathogenesis and positive aberrations, employing a series of off-label applications.

methodsRecruitment criteria include a diagnosis of PCS, a minimum age of 18 years and self-reported cognitive deficits at screening. A total of 418 participants will be randomly assigned to either verum or placebo intervention in the first phase of the trial. The trial will consist of a first trial phase intervention with methylprednisolone versus placebo for six weeks, followed by a six-week treatment interruption period. Subsequently, an open second phase will offer methylprednisolone to all participants for six weeks. Outpatient follow-up visits will take place two weeks after each trial medication cessation. The third and final follow-up, at week 52, will be conducted through a telephone interview. The primary outcome measures an intra-patient change of 15 or more points in the memory satisfaction subscale of the Multifactorial Memory Questionnaire (MMQ) from baseline to follow-up 1 (week 8). Key secondary outcomes include long-term intra-patient changes in memory satisfaction from baseline to follow-up 2 (week 20), changes in other MMQ subscales (follow-up 1 and 2), and changes in neuropsychological and cognitive scores, along with assessments through questionnaires focusing on quality of life, fatigue, and mood over the same periods. Exploratory outcomes involve molecular biomarkers variations in serum and cerebrospinal fluid, as well as structural and functional brain magnetic resonance imaging (MRI) parameters changes related to cognition. PERSPECTIVE: This trial aims to contribute novel evidence for treating patients with PCS, with a primary focus on those manifesting cognitive deficits. By doing so, it may enhance comprehension of the underlying pathophysiological mechanisms, thereby facilitating biomarker research to advance our understanding and treatment of patients with PCS.

Indexed as

GlucocorticoidsLong-COVIDMethylprednisolonePathophysiologyPlacebo-controlled trial protocolPost-COVIDTreatment

Identifiers

PMID38509608
PMCPMC10956230

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.