Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06291259 |
| Other study ID # |
CTO 4081 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 21, 2022 |
| Est. completion date |
September 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Unity Health Toronto |
| Contact |
Abby Li |
| Phone |
416-360-4000 |
| Email |
abby.li[@]unityhealth.to |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
