Image

Mpox Prospective Observational Cohort Study

Mpox Prospective Observational Cohort Study

Recruiting
All
Phase N/A

Powered by AI

Overview

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.

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.

Eligibility

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

Study details
    Monkeypox

NCT06291259

Unity Health Toronto

14 October 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.