Evidence map›Paper›PMID 38722986›Full record

ArticlePloS one2024

Expanded Access Programme for the use of tecovirimat for the treatment of monkeypox infection: A study protocol for an Expanded Access Programme.

Josephine Bourner, Festus Devincy Redji Mbrenga, Christian Noël Malaka, Jake Dunning, Amanda Rojek, Emmanuel Fandema, Peter Horby, Yap Boum, Emmanuel Nakouné, Piero Olliaro

Abstract read
In one paragraph

Article in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Treatment of mpox with tecovirimat under expanded access use in the Central African Republic.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2026
    Article
  2. Article
  3. Review
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

10 authors.

Josephine BournerPandemic Sciences Institute, University of Oxford, Oxford, United Kingdom.ORCID 0000-0003-4687-8380
Festus Devincy Redji MbrengaInstitut Pasteur de Bangui, Central African Republic, Bangui, Central African Republic.
Christian Noël MalakaInstitut Pasteur de Bangui, Central African Republic, Bangui, Central African Republic.ORCID 0000-0003-4496-2212
Jake DunningPandemic Sciences Institute, University of Oxford, Oxford, United Kingdom.
Amanda RojekPandemic Sciences Institute, University of Oxford, Oxford, United Kingdom.
Emmanuel FandemaMinistry of Health, Central African Republic, Bangui, Central African Republic.
Peter HorbyPandemic Sciences Institute, University of Oxford, Oxford, United Kingdom.
Yap BoumInstitut Pasteur de Bangui, Central African Republic, Bangui, Central African Republic.
Emmanuel NakounéInstitut Pasteur de Bangui, Central African Republic, Bangui, Central African Republic.
Piero OlliaroPandemic Sciences Institute, University of Oxford, Oxford, United Kingdom.

Funding

Bill & Melinda Gates FoundationWellcome Trust
6 · The paper itself

Abstract

backgroundMonkeypox is a viral zoonotic disease commonly reported in humans in parts of Central and West Africa. This protocol is for an Expanded Access Programme (EAP) to be implemented in the Central African Republic, where Clade I monkeypox virus diseases is primarily responsible for most monkeypox infections. The objective of the programme is to provide patients with confirmed monkeypox with access to tecovirimat, a novel antiviral targeting orthopoxviruses, and collect data on clinical and virological outcomes of patients to inform future research.

methodsThe study will be conducted at participating hospitals in the Central African Republic. All patients who provide informed consent to enrol in the programme will receive tecovirimat. Patients will remain in hospital for the duration of treatment. Data on clinical signs and symptoms will be collected every day while the patient is hospitalised. Blood, throat and lesion samples will be collected at baseline and then on days 4, 8, 14 and 28. Patient outcomes will be assessed on Day 14 -end of treatment-and at Day 28. Adverse event and serious adverse event data will be collected from the point of consent until Day 28. DISCUSSION: This EAP is the first protocolised treatment programme in Clade I MPXV. The data generated under this protocol aims to describe the use of tecovirimat for Clade I disease in a monkeypox endemic region of Central Africa. It is hoped that this data can inform the definition of outcome measures used in future research and contribute to the academic literature around the use of tecovirimat for the treatment of monkeypox. The EAP also aims to bolster research capacity in the region in order for robust randomised controlled trials to take place for monkeypox and other diseases.

trial registration{2a & 2b}: ISRCTN43307947.

Indexed as

Antiviral AgentsMpox, MonkeypoxAdolescentAdultAlanineBenzamidesFemaleHumansIsoindolesMaleMonkeypox virusPhthalimidesTreatment OutcomeAlanineAntiviral AgentsBenzamidesIsoindolesPhthalimidestecovirimat

Identifiers

PMID38722986
PMCPMC11081255

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.