Mpox Prospective Observational Cohort Study

NCT ID: NCT06291259

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-21
• Study Completion Date: 2024-09-30

Brief Summary

The goal of this multicentre prospective observational cohort study is to shed light on the following unknowns:

1. The clinical manifestations of Mpox infection since the 2022 outbreak in Canada.

2. The social and psychological impacts of Mpox infection since the 2022 outbreak in Canada

3. The transmissibility of Mpox infection

4. Viral shedding over time in infected individuals

The study is divided into Part 1 (corresponding to the acute phase of illness) and Part 2 (corresponding to the convalescent phase of the illness); part 2 will be optional. Participants enrolled during the acute phase of illness will complete part 1 of the study and will be invited to participate in Part 2 as well. Part 1 of the study will include the following three core components, at baseline and weekly (±3 days) until one week after the resolution of all symptoms (i.e. one week after complete healing of skin lesions):

1. Collection of clinical data through chart review and research staff interviews with study participants

2. Participant self-administered online questionnaires at baseline and a thrice-weekly 'acute phase participant diary'

3. Specimen collection for Mpox-related testing Optional components for Part 1 include baseline-only, questionnaire-only, and frequent sampling.

Other optional components for all participants include in the Image Atlas, an online database of clinical images of mpox, designed to provide clinicians and community members of what mpox looks like in real life, and the biobank, which will store research samples for potential future studies.

Detailed Description

Mpox is caused by a virus that normally infects animals (rodents, monkeys, and others), but can sometimes infect humans. In the past, it was usually only seen in a few specific countries, but since the beginning of May 2022 it has been reported in many other countries, including Canada, where it has never been seen before. The virus can cause several symptoms, including "flu-like" symptoms (fever, headache, feeling tired, muscle pains, swollen glands, sore throat) and skin symptoms (spots, bumps, blisters, open sores, scabs). However, sometimes it can also cause very few symptoms, or no symptoms at all. Mpox can be spread from one person to another in a few ways, such as directly touching the affected skin areas of someone who has the infection, touching sheets or clothes that were used by someone with the infection, or breathing in particles of virus that came from the nose, mouth and lungs of someone with the infection ("respiratory droplets").

In the cases seen around the world since May 2022, doctors and patients have noticed many things that are unusual for mpox infection. Some of these relate to the symptoms people have had (for example, the order in which people get different symptoms might be changing), and the ways in which it has been spread from person to person (for example, we do not know if it can be spread through sex). There is also worry that the infection could have bad effects on people's financial situation and emotional wellness, especially because people with mpox have to self-isolate at home for several days or weeks until the infection is completely over, to protect public health. Finally, there is also a lot that doctors and scientists still do not yet know about the virus itself, including the specific parts of the body where it can be found, the amount of time that it stays in those parts of the body, and its biology (e.g. its "genetic sequence" or genes).

The purpose of this study is to learn more about 1) the symptoms people have, 2) the ways mpox is spread, 3) the effects on people's lives, and 4) the virus itself, including the places in the body and surrounding environment where it can live. Canada is currently experiencing an outbreak and the outlined purposes are critical and relevant to clinical and public health control efforts.

The study is divided into Part 1 (corresponding to the acute phase of illness) and Part 2 (corresponding to the convalescent phase of the illness); part 2 will be optional. Participants enrolled during the acute phase of illness will complete part 1 of the study and will be invited to participate in Part 2 as well. Part 1 of the study will include the following three core components, at baseline and weekly (±3 days) until one week after the resolution of all symptoms (i.e. one week after complete healing of skin lesions):

1. Collection of clinical data through chart review and research staff interviews with study participants

2. Participant self-administered online questionnaires at baseline and a thrice-weekly 'acute phase participant diary'

3. Specimen collection for Mpox-related testing Optional components for Part 1 include baseline-only, questionnaire-only, and frequent sampling.

Other optional components for all participants include in the Image Atlas, an online database of clinical images of mpox, designed to provide clinicians and community members of what mpox looks like in real life, and the biobank, which will store research samples for potential future studies.

Conditions

Monkeypox

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Confirmed positive for mpox

Participants with laboratory test results confirming the diagnosis of Mpox. This includes the total number of unique participants who complete the main part 1 study, those who complete the baseline visit only, those who agree to frequent sampling, and those who only participate in part 2.

No interventions assigned to this group

Confirmed negative for mpox

Participants in whom the clinician feels that the diagnosis of Mpox has been clearly ruled out.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

Part 1:

• Being investigated for Mpox infection by a clinician based on clinical (i.e. symptoms) and/or epidemiologic (i.e. exposure to confirmed case) grounds;

Part 2:

• Clinically confirmed to be in the convalescent phase (i.e. confirmed for Mpox infection previously)
• Within 12 weeks of symptom onset

Exclusion Criteria

• None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Darrell HS Tan, MD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

BC Centre For Excellence

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Unity Health Toronto

Toronto, Ontario, Canada

Site Status: RECRUITING

University Health Network

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Abby Li

Role: CONTACT

abby.li@unityhealth.to

416-360-4000 ext. 77426

Facility Contacts

Brody Lyon

Role: primary

blyons@bccfe.ca

604-682-2344 ext. 66230

Shreya Shah

Role: primary

shreya.khera@unityhealth.to

416-360-4000 ext. 77312

Asmaa Mabrouk

Role: primary

Asmaa.mabrouk@uhn.ca

416-340-4800 ext. 2240

Other Identifiers

CTO 4081

Identifier Type: -

Identifier Source: org_study_id