Viral Clearance and Epidemiological Characteristics in Patients With Monkeypox (MoViE)

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 Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 77

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

• Spain
  • Barcelona, Spain, 08001
    • Drassanes Vall d'Hebron Centre for International Health and Infectious diseases
  • Barcelona, Spain, 08015
    • BCN CheckPoint
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitari Germans Trias i Pujol
    • Sabadell, Barcelona, Spain, 08204
      • Atenció Primària Metropolitana Nord

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult male and female patients with monkeypox infection.

Description

• Inclusion Criteria

  1. Adult male or female individuals of ≥18 years old.
  2. Examined by a specialist in sexually transmitted infections (STIs) and found to have lesions suggestive of monkeypox.
  3. Symptomatic with symptoms onset date ≤10 days prior to screening/baseline visit.
  4. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the trial.
  5. Has understood the information provided and capable of giving informed consent.

• Exclusion criteria:

  1. Severe disease - defined as requires admission to hospital
  2. Inability to consent and/or comply with trial protocol
  3. An alternative confirmed diagnosis that can fully explain the illness

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
• Collaborators: IrsiCaixa; CEEISCAT

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2022
• Primary Completion (Actual): September 22, 2022
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 27, 2022

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Monkeypox; Viral clearance; Viral dynamics
• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Poxviridae Infections; Monkeypox
• Other Study ID Numbers: MoViE Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No