Viral Clearance and Epidemiological Characteristics in Patients With Monkeypox

Study Overview
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Brief Summary
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The present observational study has been designed to understand the dynamics of viral clearance amongst patients with confirmed monkeypox, by quantifying monkeypox viral load in different specimens trough time, to better inform decision-making about patient management and isolation guidelines. Also, an immune analysis will be performed in a subset of individuals to describe humoral and cellular responses to monkeypox.

Detailed Description
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Starting in early May 2022 a large number of cases of Monkeypox have been reported in non-endemic countries. Although initial cases appeared to be linked to travel, the majority of subsequent cases appear to have no travel associated risk factors and these cases have predominantly occurred amongst Men who have Sex with Men (MSM) suggesting autochthonous transmission associated with sexual networks. Monkeypox is known to be transmitted by close contact with skin lesions of infected individuals and/or via droplets. It is known that the virus can be detected from skin lesions, in blood, in throat swabs and on occasion urine samples. There is limited information as to whether the virus can be detected or persist in other sites including semen. Serial virological monitoring has been conducted in a small number of individuals and demonstrates that prolonged shedding for at least 2-3 weeks appears to be relatively common. To help control the current outbreak health authorities have used a number of strategies including identifying and isolating cases of monkeypox combined with contact tracing and limited use of ring-vaccination strategies. Because the number of cases seen outside of endemic areas has previously been limited, there is inadequate data to guide decision-making about the duration of isolation, but this is critical to the management of the current outbreak. The present observational study has been designed to understand the dynamics of viral clearance amongst patients with confirmed monkeypox, by quantifying monkeypox viral load in different specimens trough time, to better inform decision-making about patient management and isolation guidelines. Also, an immune analysis will be performed in a subset of individuals to describe humoral and cellular responses to monkeypox.

Official Title
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Viral Clearance and Epidemiological Characteristics in Patients With Monkeypox

Conditions
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Monkeypox

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Adult male or female individuals of ≥18 years old. Examined by a specialist in sexually transmitted infections (STIs) and found to have lesions suggestive of monkeypox. Symptomatic with symptoms onset date ≤10 days prior to screening/baseline visit. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the trial. Has understood the information provided and capable of giving informed consent. Exclusion criteria: Severe disease - defined as requires admission to hospital Inability to consent and/or comply with trial protocol An alternative confirmed diagnosis that can fully explain the illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral clearance in skin lesions | Time to undetectable monkeypox viral load in skin lesions (Number of days) | From day 1 to day 57 | 
| Viral clearance in blood | Time to undetectable monkeypox viral load in blood (Number of days) | From day 1 to day 57 | 
| Viral clearance in oropharyngeal swabs | Time to undetectable monkeypox viral load (Ct) in oropharyngeal swabs (Number of days) | From day 1 to day 57 | 
| Viral clearance in rectum swabs | Time to undetectable monkeypox viral load (Ct) in rectum swabs (Number of days) | From day 1 to day 57 | 
| Viral clearance in semen discharge | Time to undetectable monkeypox viral load in semen (Number of days) | From day 1 to day 57 | 
| Viral clearance in vaginal discharge | Time to undetectable monkeypox viral load in vaginal discharge (Number of days) | From day 1 to day 57 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Humoral responses against monkeypox | Neutralization titers against monkeypox in a subset of participants (Neutralization titers) | At baseline and 1, 3, and 6 months later | 
| Cellular responses against monkeypox | Presence of specific immunity cells against monkeypox (Presence of cells) | At baseline and 1, 3, and 6 months later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Monkeypox, Viral clearance, Viral dynamics