MonkeypoxMoViENCT05476744
Viral Clearance and Epidemiological Characteristics in Patients With Monkeypox
An observational study of Monkeypox, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 5 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Monkeypox
- How many people
- 77 participants
- Where
- 5 sitesSpain
- Study dates
- 28 Jun 2022to 30 Mar 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult male and female patients with monkeypox infection.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Drassanes Vall d'Hebron Centre for International Health and Infectious diseases
Barcelona, 08001
BCN Checkpoint
Barcelona, 08015
Hospital Universitario 12 de Octubre
Madrid, 28041
Atenció Primària Metropolitana Nord
Sabadell, Barcelona, 08204
About this study
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.
Read the 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.
- Conditions
- Monkeypox
- Keywords
- Monkeypox, Viral clearance, Viral dynamics
- Medical subject headings
- Mpox, Monkeypox
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral clearance in skin lesions
Time to undetectable monkeypox viral load in skin lesions (Number of days)
Measured: From day 1 to day 57
Viral clearance in blood
Time to undetectable monkeypox viral load in blood (Number of days)
Measured: From day 1 to day 57
Viral clearance in oropharyngeal swabs
Time to undetectable monkeypox viral load (Ct) in oropharyngeal swabs (Number of days)
Measured: From day 1 to day 57
Viral clearance in rectum swabs
Time to undetectable monkeypox viral load (Ct) in rectum swabs (Number of days)
Measured: From day 1 to day 57
Viral clearance in semen discharge
Time to undetectable monkeypox viral load in semen (Number of days)
Measured: From day 1 to day 57
Viral clearance in vaginal discharge
Time to undetectable monkeypox viral load in vaginal discharge (Number of days)
Measured: From day 1 to day 57
Secondary outcomes (2)
Humoral responses against monkeypox
Neutralization titers against monkeypox in a subset of participants (Neutralization titers)
Measured: At baseline and 1, 3, and 6 months later
Cellular responses against monkeypox
Presence of specific immunity cells against monkeypox (Presence of cells)
Measured: At baseline and 1, 3, and 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start28 Jun 2022
- Primary completion22 Sep 2022
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MonkeypoxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Sponsor type
- University, hospital or other
- Collaborators
- IrsiCaixa, CEEISCAT
- Responsible party
- Principal investigator, Oriol Mitja, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476744
- Sponsor's protocol ID
- MoViE Study
- Acronym
- MoViE
- Status last verified
- Sep 2023
- First submitted
- 21 Jul 2022
- Last updated
- 18 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viral Clearance and Epidemiological Characteristics in Patients With Monkeypox
- ClinicalTrials.gov ID
- NCT05476744
- Acronym / sponsor ID
- MoViE / MoViE Study
- Conditions
- Monkeypox
- Keywords
- Monkeypox, Viral clearance, Viral dynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaUniversity, hospital or other
- Collaborators
- IrsiCaixa, CEEISCAT
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 27 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male and female patients with monkeypox infection.
Key inclusion criteria (5 listed)
Key exclusion criteria (3 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Viral clearance in skin lesions
Time frame: From day 1 to day 57
Time to undetectable monkeypox viral load in skin lesions (Number of days)
Viral clearance in blood
Time frame: From day 1 to day 57
Time to undetectable monkeypox viral load in blood (Number of days)
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)
Viral clearance in rectum swabs
Time frame: From day 1 to day 57
Time to undetectable monkeypox viral load (Ct) in rectum swabs (Number of days)
Viral clearance in semen discharge
Time frame: From day 1 to day 57
Time to undetectable monkeypox viral load in semen (Number of days)
Viral clearance in vaginal discharge
Time frame: From day 1 to day 57
Time to undetectable monkeypox viral load in vaginal discharge (Number of days)
2 secondary outcomes
Humoral responses against monkeypox
Time frame: At baseline and 1, 3, and 6 months later
Cellular responses against monkeypox
Time frame: At baseline and 1, 3, and 6 months later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Monkeypox, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral clearance in skin lesions (time frame: From day 1 to day 57). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.