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Completed

NCT Number: NCT05476744

Viral Clearance and Epidemiological Characteristics in Patients With Monkeypox

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Primary outcomes

  1. 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)

  2. Viral clearance in blood

    Time frame: From day 1 to day 57

    Time to undetectable monkeypox viral load in blood (Number of days)

  3. 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)

  4. 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)

  5. Viral clearance in semen discharge

    Time frame: From day 1 to day 57

    Time to undetectable monkeypox viral load in semen (Number of days)

  6. 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)

Secondary outcomes

  1. Humoral responses against monkeypox

    Time frame: At baseline and 1, 3, and 6 months later

    Neutralization titers against monkeypox in a subset of participants (Neutralization titers)

  2. Cellular responses against monkeypox

    Time frame: At baseline and 1, 3, and 6 months later

    Presence of specific immunity cells against monkeypox (Presence of cells)

Sponsors and collaborators

Lead sponsor

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Other

Collaborators

  • CEEISCAT
  • IrsiCaixa

Registry information

Acronym: MoViE

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 27, 2022
Registry last updated
Sep 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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