MonkeypoxMPOCSNCT06291259
Mpox Prospective Observational Cohort Study
An observational study of Monkeypox, run by Unity Health Toronto at 3 sites in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Monkeypox
- How many people
- 250 participants
- Where
- 3 sitesCanada
- Study dates
- 21 Jun 2022to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Our overarching goal is to characterize key clinical and epidemiologic aspects of Mpox infection in Canada in the context of the rapidly emerging outbreak. As such we will deliberately include people both with (n=250) and without (number to be determined based on accrual of confirmed cases) the condition of interest because it is important to have a comparison group of people who are ultimately confirmed not to have the infection
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country.
Canada3 sites, 3 recruiting
- Recruiting
Unity Health Toronto
Toronto, Ontario, M5B 1T8
Shreya Shah, 416-360-4000 ext. 77312, shreya.khera@unityhealth.to
Darrell HS Tan
- Recruiting
University Health Network
Toronto, Ontario
Asmaa Mabrouk, 416-340-4800 ext. 2240, Asmaa.mabrouk@uhn.ca
Sharon Walmsley, MD
- Recruiting
BC Centre For Excellence
Vancouver, British Columbia, V6Z 1Y6
Brody Lyon, 604-682-2344 ext. 66230, blyons@bccfe.ca
Mark Hull, MD
About this study
The goal of this multicentre prospective observational cohort study is to shed light on the following unknowns:
- The clinical manifestations of Mpox infection since the 2022 outbreak in Canada.
- The social and psychological impacts of Mpox infection since the 2022 outbreak in Canada
- The transmissibility of Mpox infection
- Viral shedding over time in infected individuals
Read more
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):
- Collection of clinical data through chart review and research staff interviews with study participants
- Participant self-administered online questionnaires at baseline and a thrice-weekly 'acute phase participant diary'
- 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.
Read the 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):
- Collection of clinical data through chart review and research staff interviews with study participants
- Participant self-administered online questionnaires at baseline and a thrice-weekly 'acute phase participant diary'
- 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
- Keywords
- mpox
- Medical subject headings
- Mpox, Monkeypox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| Confirmed negative for mpox | Participants in whom the clinician feels that the diagnosis of Mpox has been clearly ruled out. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of clinical manifestation
Clinical manifestations of mpox infection during the Canadian outbreak, including symptom duration and spectrum, complications, natural history and sources of variability in clinical manifestations
Measured: 12 weeks
Psychosocial impact
Describe the psychosocial impacts of mpox-related illness and isolation requirements, including financial insecurity, psychological distress and perceived and enacted stigma
Measured: 12 weeks
Transmission-related aspects of mpox infection
Types and timing of human and animal contacts prior to mpox infection, as well as quantifying the detectability of mpox viral DNA in the immediate environment of people ultimately diagnosed with the infection, including physical surfaces and air samples
Measured: 12 weeks
Virologic aspects of mpox infection over time
Detectability of mpox viral DNA by polymerase chain reaction (PCR) along with the associated cycle threshold, as well as titers of infectious virus, in different anatomic compartments and examining the viral genomic sequence. Outcomes also include characterizing the host response to mpox infection including host gene and cytokine expression and antibody titers.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start21 Jun 2022
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MonkeypoxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Darrell HS Tan, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291259
- Sponsor's protocol ID
- CTO 4081
- Acronym
- MPOCS
- Status last verified
- Feb 2024
- First submitted
- 26 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mpox Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06291259
- Acronym / sponsor ID
- MPOCS / CTO 4081
- Conditions
- Monkeypox
- Keywords
- mpox
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this multicentre prospective observational cohort study is to shed light on the following unknowns:
- The clinical manifestations of Mpox infection since the 2022 outbreak in Canada.
- The social and psychological impacts of Mpox infection since the 2022 outbreak in Canada
- The transmissibility of Mpox infection
- 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):
- Collection of clinical data through chart review and research staff interviews with study participants
- Participant self-administered online questionnaires at baseline and a thrice-weekly 'acute phase participant diary'
- 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):
- Collection of clinical data through chart review and research staff interviews with study participants
- Participant self-administered online questionnaires at baseline and a thrice-weekly 'acute phase participant diary'
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| Confirmed negative for mpox | – | –Participants in whom the clinician feels that the diagnosis of Mpox has been clearly ruled out. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Our overarching goal is to characterize key clinical and epidemiologic aspects of Mpox infection in Canada in the context of the rapidly emerging outbreak. As such we will deliberately include people both with (n=250) and without (number to be determined based on accrual of confirmed cases) the condition of interest because it is important to have a comparison group of people who are ultimately confirmed not to have the infection
Key inclusion criteria (5 listed)
- Being investigated for Mpox infection by a clinician based on clinical (i.e. symptoms) and/or epidemiologic (i.e. exposure to confirmed case) grounds;
- Clinically confirmed to be in the convalescent phase (i.e. confirmed for Mpox infection previously)
- Within 12 weeks of symptom onset
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of clinical manifestation
Time frame: 12 weeks
Clinical manifestations of mpox infection during the Canadian outbreak, including symptom duration and spectrum, complications, natural history and sources of variability in clinical manifestations
Psychosocial impact
Time frame: 12 weeks
Describe the psychosocial impacts of mpox-related illness and isolation requirements, including financial insecurity, psychological distress and perceived and enacted stigma
Transmission-related aspects of mpox infection
Time frame: 12 weeks
Types and timing of human and animal contacts prior to mpox infection, as well as quantifying the detectability of mpox viral DNA in the immediate environment of people ultimately diagnosed with the infection, including physical surfaces and air samples
Virologic aspects of mpox infection over time
Time frame: 12 weeks
Detectability of mpox viral DNA by polymerase chain reaction (PCR) along with the associated cycle threshold, as well as titers of infectious virus, in different anatomic compartments and examining the viral genomic sequence. Outcomes also include characterizing the host response to mpox infection including host gene and cytokine expression and antibody titers.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
Related trials for Monkeypox
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New York City Observational Study of Mpox Immunity
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Smart Analysis and Decision-Making for Emerging Infectious Diseases
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darrell HS Tan, MD principal investigator
Unity Health Toronto
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Monkeypox, run by Unity Health Toronto at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abby Li (416-360-4000 ext. 77426, abby.li@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of clinical manifestation (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.