Viral Clearance and Epidemiological Characteristics in Patients With Monkeypox

Monkeypox Clinical Trial

— MoViE  

Official title:

Viral Clearance and Epidemiological Characteristics in Patients With Monkeypox

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05476744
• Other study ID #: MoViE Study
• Status: Completed
• Start date: June 28, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: September 2023
• Source: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. Also, an immune analysis will be performed in a subset of individuals to describe humoral and cellular responses to monkeypox.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: March 30, 2023
• Est. primary completion date: September 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Monkeypox

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	BCN Checkpoint	Barcelona
Spain	Drassanes Vall d'Hebron Centre for International Health and Infectious diseases	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Atenció Primària Metropolitana Nord	Sabadell	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia	CEEISCAT, IrsiCaixa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral clearance in skin lesions	Time to undetectable monkeypox viral load in skin lesions (Number of days)	From day 1 to day 57
Primary	Viral clearance in blood	Time to undetectable monkeypox viral load in blood (Number of days)	From day 1 to day 57
Primary	Viral clearance in oropharyngeal swabs	Time to undetectable monkeypox viral load (Ct) in oropharyngeal swabs (Number of days)	From day 1 to day 57
Primary	Viral clearance in rectum swabs	Time to undetectable monkeypox viral load (Ct) in rectum swabs (Number of days)	From day 1 to day 57
Primary	Viral clearance in semen discharge	Time to undetectable monkeypox viral load in semen (Number of days)	From day 1 to day 57
Primary	Viral clearance in vaginal discharge	Time to undetectable monkeypox viral load in vaginal discharge (Number of days)	From day 1 to day 57
Secondary	Humoral responses against monkeypox	Neutralization titers against monkeypox in a subset of participants (Neutralization titers)	At baseline and 1, 3, and 6 months later
Secondary	Cellular responses against monkeypox	Presence of specific immunity cells against monkeypox (Presence of cells)	At baseline and 1, 3, and 6 months later