Observational cohort study to understand transmission and relationship to disease severity and duration in human Mpox disease in Democratic Republic of the Congo (DRC)

Mpox (formally known as monkey pox) is a viral disease that causes a fever and a rash and can be more severe in some people. In this protocol we describe a study to enrol patients with Mpox disease to understand whether the disease changes depending on how it is caught. We also want to monitor the time it takes to recover from infection. We plan to enrol adults and children who will think have Mpox from their symptoms who then test positive for Mpox and who agree to being involved in the study after we have explained the benefits and potential risks. In the study we will not be providing any additional treatments, or changing the care that patients are receiving through their medical team. We will be monitoring patients from Day 1 up to 1 year follow-up to understand more about their disease, clinical outcome, signs, and symptoms. We will also be working in the community to understand how the disease is passed within and outside households. We are also going to see whether animals such as monkeys, rats and squirrels also get this disease and if they can pass it to humans. To check how quickly patients recover from Mpox we will monitor signs and symptoms via a form that patients fill in each day, and also check how quickly patients clear the virus (through blood tests and by throat swabs and lesion swabs). We will review patients when they are enrolled and after 2 weeks, and 1, 2, 6, and 12 months in hospital and at home. We expect to enrol around 150 patients. This study is led by local researchers and includes experts in infectious diseases from around the world. When the study is complete, we will publish the anonymised results in a scientific journal so the results can be used by others we will also make sure the local community are told about the results. This study is co-funded with FCDO under the MRC/FCDO Concordat agreement.