Monkeypox observational cohort
Research type
Research Study
Full title
Prospective observational cohort study of treatment outcomes in human monkeypox virus disease
IRAS ID
316821
Contact name
Piero Olliaro
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Research Summary
This observational cohort study aims to collect virological and clinical data on patients with confirmed monkeypox virus disease in in-patient and outpatient settings in the UK and Europe. We are interested in particular about learning more about the safety of treatments that patients are receiving, including the licensed treatment, tecovirimat.
The study aims to collect data on the clinical and virological outcomes of the patients enrolled. This is not a randomised study.
Clinical data will be collected from patients via an online diary and from their direct care team. Patients will also have blood, lesion and throat swab samples taken between 4-6 timepoints, depending on their virological status on Days 14 and 21.
Participation in the study will last for approximately 6 months from the point of enrollment.
Local ethical and other required approvals will be sought in all participating countries.
Lay summary of study results
In May 2022, a new variant of the mpox virus (previously known as monkeypox) caused a global outbreak. This variant, called clade 2b, differs from the mpox typically seen in Africa, particularly in how it spreads and the symptoms it causes.
To better understand this outbreak, researchers conducted a study called MOSAIC between May 2022 and July 2023 and sponsored by the University of Oxford. They enrolled 602 individuals infected with mpox in six European countries (Belgium, France, Italy, Spain, Switzerland, and the United Kingdom) who were followed for up to six months. They collected data through hospital visits, phone interviews, and self-completed questionnaires. The study aimed to characterise the clinical features of the disease and to measure how long it took for skin lesions to heal and for the virus to clear.
Of the 575 participants included in the analysis, most were men aged 30-45 years, nearly half were living with HIV. Ten percent received antiviral treatment specifically for mpox, based on clinical presentation and limited availability of specific medications. The study design did not allow researchers to fully assess the effectiveness of the antiviral treatments, as it was not designed to compare treated and untreated participants.
Lesions were mostly affecting the skin around the genitals and anus. It took time for lesions to heal and to get rid of the virus. Importantly, 5% of the participants still had viable virus in skin lesions, which means they can still transmit the infection, 7-8 weeks after testing positive.
There were no deaths, and no one experienced a recurrence of infection within the six-month follow-up period.
Overall, this study provides valuable insights into how the new mpox variant affects patients and risks of onward transmission that are useful for case management, public health measures, and personal behaviours, and underscores the need for further research to improve responses to ongoing outbreaks.
For more detailed results, please refer to the full article https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fdoi.org%252F10.1093%252Fcid%252Fciae657.%2FNBTI%2Fv4m6AQ%2FAQ%2Fdfa6d4f7-4e5c-4840-98e8-4d454b729962%2F2%2FgN-BXVtdBW&data=05%7C02%7Ccambridgeeast.rec%40hra.nhs.uk%7C7e642f9e77d84ceffb3208dd2efe7a31%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638718392677412453%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=9L4cK1ViXo4QMxfDBudg3%2F9S1Gz4iKZjImyr6cfhFJs%3D&reserved=0REC name
East of England - Cambridge East Research Ethics Committee
REC reference
22/EE/0143
Date of REC Opinion
27 Jun 2022
REC opinion
Further Information Favourable Opinion