- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05476744
Viral Clearance and Epidemiological Characteristics in Patients With Monkeypox (MoViE)
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Clara Suñer
- Phone Number: 673684960
- Email: csuner@lluita.org
Study Contact Backup
- Name: Maria Ubals
- Phone Number: 673684960
- Email: mubals@lluita.org
Study Locations
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Barcelona, Spain, 08001
- Drassanes Vall d'Hebron Centre for International Health and Infectious diseases
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Barcelona, Spain, 08015
- BCN CheckPoint
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Madrid, Spain, 28041
- Hospital Universitario 12 de Octubre
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Barcelona
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Badalona, Barcelona, Spain, 08916
- Hospital Universitari Germans Trias i Pujol
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Sabadell, Barcelona, Spain, 08204
- Atenció Primària Metropolitana Nord
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Viral clearance in skin lesions
Time Frame: From day 1 to day 57
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Time to undetectable monkeypox viral load in skin lesions (Number of days)
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From day 1 to day 57
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Viral clearance in blood
Time Frame: From day 1 to day 57
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Time to undetectable monkeypox viral load in blood (Number of days)
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From day 1 to day 57
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Viral clearance in oropharyngeal swabs
Time Frame: From day 1 to day 57
|
Time to undetectable monkeypox viral load (Ct) in oropharyngeal swabs (Number of days)
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From day 1 to day 57
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Viral clearance in rectum swabs
Time Frame: From day 1 to day 57
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Time to undetectable monkeypox viral load (Ct) in rectum swabs (Number of days)
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From day 1 to day 57
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Viral clearance in semen discharge
Time Frame: From day 1 to day 57
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Time to undetectable monkeypox viral load in semen (Number of days)
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From day 1 to day 57
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Viral clearance in vaginal discharge
Time Frame: From day 1 to day 57
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Time to undetectable monkeypox viral load in vaginal discharge (Number of days)
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From day 1 to day 57
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Humoral responses against monkeypox
Time Frame: At baseline and 1, 3, and 6 months later
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Neutralization titers against monkeypox in a subset of participants (Neutralization titers)
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At baseline and 1, 3, and 6 months later
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Cellular responses against monkeypox
Time Frame: At baseline and 1, 3, and 6 months later
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Presence of specific immunity cells against monkeypox (Presence of cells)
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At baseline and 1, 3, and 6 months later
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MoViE Study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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