Evidence map›Paper›PMID 39726799›Full record

ArticleAnnals of clinical epidemiology2024

Efficacy of Donepezil for Fatigue and Psychological Symptoms in Post-COVID-19 Condition: Study Protocol for a Multicenter Randomized, Placebo-controlled, Double-blind Trial.

Keiichiro Kawabata, Kensuke Nakamura, Kazuhiro Kondo, Naomi Oka, Azusa Ishii, Masafumi Idei, Kazuma Yamakawa, Kenya Ie, Yusuke Yamamoto, Kazuo Nishi and 6 more

Abstract read
In one paragraph

Article in Annals of clinical epidemiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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

2 citing papers in PubMed.

  1. Trial
  2. 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

16 authors.

Keiichiro KawabataDepartment of Critical Care Medicine, Yokohama City University Hospital, Kanagawa, Japan.
Kensuke NakamuraDepartment of Critical Care Medicine, Yokohama City University Hospital, Kanagawa, Japan.
Kazuhiro KondoDepartment of Virology, The Jikei University School of Medicine, Tokyo, Japan.
Naomi OkaDepartment of Virology, The Jikei University School of Medicine, Tokyo, Japan.
Azusa IshiiDepartment of Virology, The Jikei University School of Medicine, Tokyo, Japan.
Masafumi IdeiDepartment of Critical Care Medicine, Yokohama City University Hospital, Kanagawa, Japan.
Kazuma YamakawaDepartment of Emergency and Critical Care Medicine, Osaka Medical and Pharmaceutical University, Osaka, Japan.
Kenya IeDepartment of General Internal Medicine, Kawasaki Municipal Tama Hospital, Kanagawa, Japan.
Yusuke YamamotoDepartment of Respiratory Medicine, Hitachi General Hospital, Hitachi, Ltd., Ibaraki, Japan.
Kazuo NishiYushoukai Medical Corporation Association, Yushoukai Home Care Clinic Shinagawa, Tokyo, Japan.
Koichi HirahataSoyukai Medical Corporation Association, Hirahata Clinic, Tokyo, Japan.
Ryo KikuchiFast doctor Incorporated, Tokyo, Japan.
Hideki YoshidaDepartment of Emergency and Critical Care Medicine, St. Marianna University School of Medicine, Kanagawa, Japan.
Hiroki SaitoDepartment of Emergency and Critical Care Medicine, St. Marianna University School of Medicine, Kanagawa, Japan.
Tadahiro GotoTXP Medical Co. Ltd., Tokyo, Japan.
Shigeki FujitaniDepartment of Emergency and Critical Care Medicine, St. Marianna University School of Medicine, Kanagawa, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundApproximately 30% of coronavirus disease 2019 COVID-19 patients develop fatigue and psychological symptoms. We previously demonstrated the efficacy of donepezil, an acetylcholinesterase inhibitor that is widely used to treat dementia, in basic research.

methodsThis is a multicenter, double-blind, randomized, controlled, phase II clinical trial in which 120 patients with COVID-19 will be randomized in a 1:1 ratio to a donepezil or placebo group. Inclusion criteria are as follows: (1) Adult. (2) With COVID-19 infection who had an upper respiratory tract infection, fever, or cough in the acute phase. (3) With a global binary fatigue score ≥4 on the Chalder Fatigue Scale assessment (4) Within 52 weeks of the onset of COVID-19. (5) Patients who provide consent themselves. In the donepezil group, a low dose (3 mg/day) is administered for the first week and is increased to 5 mg/day for 2 weeks. The control group receives placebo for 3 weeks. The primary endpoint is a change in and the absolute value of the Chalder Fatigue Scale score after 3 weeks of treatment. Secondary endpoints are a change in and the absolute value of the Chalder Fatigue Scale score after 8 weeks of treatment, the other mental scores after 3 and 8 weeks of treatment, a symptom survey, adverse events, and medication compliance rate.

resultsThis study protocol is ongoing and the results will be analyzed in April 2024.

conclusionsThe off-label use of donepezil at the default dose for dementia has potential for the treatment of post-COVID-19 condition.

Indexed as

acetylcholineCOVID-19depressionDonepezilfatigue

Identifiers

PMID39726799
PMCPMC11668688

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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.