Viral Clearance and Epidemiological Characteristics in Patients With Monkeypox

Completed

• Conditions: Monkeypox

• Registration Number: NCT05476744
• Lead Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Brief 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. 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 Timeline

• Study Start: 2022-06-28
• Study First Submitted: 2022-07-21
• Study First Submitted QC: 2022-07-25
• Study First Posted: 2022-07-27
• Primary Completion: 2022-09-22
• Study Completion: 2023-03-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Viral clearance in blood	From day 1 to day 57	Time to undetectable monkeypox viral load in blood (Number of days)
Viral clearance in rectum swabs	From day 1 to day 57	Time to undetectable monkeypox viral load (Ct) in rectum swabs (Number of days)
Viral clearance in skin lesions	From day 1 to day 57	Time to undetectable monkeypox viral load in skin lesions (Number of days)
Viral clearance in oropharyngeal swabs	From day 1 to day 57	Time to undetectable monkeypox viral load (Ct) in oropharyngeal swabs (Number of days)
Viral clearance in vaginal discharge	From day 1 to day 57	Time to undetectable monkeypox viral load in vaginal discharge (Number of days)
Viral clearance in semen discharge	From day 1 to day 57	Time to undetectable monkeypox viral load in semen (Number of days)

Secondary Outcome Measures

Name	Time	Method
Humoral responses against monkeypox	At baseline and 1, 3, and 6 months later	Neutralization titers against monkeypox in a subset of participants (Neutralization titers)
Cellular responses against monkeypox	At baseline and 1, 3, and 6 months later	Presence of specific immunity cells against monkeypox (Presence of cells)

Trial Locations

Locations (5)

Hospital Universitari Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Atenció Primària Metropolitana Nord; 🇪🇸 Sabadell, Barcelona, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Drassanes Vall d'Hebron Centre for International Health and Infectious diseases; 🇪🇸 Barcelona, Spain

BCN Checkpoint; 🇪🇸 Barcelona, Spain