Mpox (monkeypox) Infections and Infestations Monkeypox
Conditions
Interventions
All patients who receive a laboratory-confirmed diagnosis of monkeypox will be eligible to access treatment with tecovirimat.
If patients agree to participate, on admission they will be asked about t
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients weighing =13 kg 2. Present with monkeypox disease as determined by clinical signs and symptoms that include a characteristic rash preceded by fever. Blood and lesion swab will be taken for confirmation by qPCR positivity for monkeypox virus DNA. 3. Close contacts of patients with confirmed monkeypox who develop fever may be tested by qPCR (prior to or after rash development) and if positive would be eligible for treatment
Exclusion criteria
Exclusion criteria: Subjects taking repaglinide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expanded Access Programs (EAPs) do not use or assess outcome measures in their analysis. This is because EAPs are primarily conducted to provide patients with access to drugs that would not normally be available and this is done outside of a clinical trial setting. EAPs cannot measure outcomes for a variety of reasons: a) only limited research data on safety and efficacy is collected, b) sample sizes are too small and there’s too much heterogeneity for any inferences to be made, c) unlike a clinical trial, the data collected as part of an EAP wouldn’t normally support the regulatory process. So while research data is collected as part of an EAP, outcome measures aren’t evaluated as they would not yield any meaningful analyses. The data collected to monitor efficacy has been described under 'Secondary outcome measures'. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total number, type and location of lesions measured clinically/visually at days 1 – 14 and 28 2. Temperature measured using a thermometer at days 1 to 14 3. Degree of incapacity measured assessed clinically at days 1 to 15 and 28 4. Complications: (1) gastrointestinal (diarrhoea or vomiting), (2) upper respiratory (includes runny nose and sore throat), (3) lower respiratory (includes wheeze, cough, and respiratory distress), (4) systemic (includes lymphadenopathy, muscle ache, back pain, headache); (5) ocular (keratitis, corneal ulceration); (6) neurological (confusion, seizures) assessed clinically at days 1 – 15 and 28 5. Whether the subject has survived with or without sequelae or succumbed to disease, assessed clinically at day 15 (after completion of treatment) and day 28 6. Viral load and serology: total exposure to the virus in the bloodstream over the course of treatment (area under the curve), maximum viral load, time to clearance of viral DNA from the blood, and antibody responses, measured using blood (5 ml) collected prior to the first dose and then on days 4, 8, 14 and 28 | — |
Countries
Central African Republic
Contacts
Public ContactJosephine Bourner
Outcome results
None listed