MonkeypoxNCT05784038
Observational, Prospective, Cohort Study of Mpox Infection in Brazil (NETPOX)
An observational study of Monkeypox and MPOX, run by Hospital Israelita Albert Einstein at 3 sites in Brazil.
Trial summary
The study is a prospective cohort that evaluates the clinical and immune-metabolic variables that may be linked to the risk and severity of the infection or even hospitalization or death in patients infected with the Mpox virus in Brazil. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Viral genomic and Untargeted Metabolomics
- How many people
- 80 participants
- Where
- 3 sitesBrazil
- Study dates
- 16 Jul 2024to Dec 2026
- How long will I take part?
- 10 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals who have risk factors for mpox infection in Brazil.
Who may be able to join
- Men and women aged ≥ 18 years with confirmed MPOX infection.
- (laboratory-confirmed monkeypox infection is defined as determined by PCR, culture, or antigen test obtained from a sample collected from blood, oropharynx, anal or skin lesion within 4 days of randomization)
Who cannot join
- Inability to provide informed consent;
- Patient who, judging by the study team, does not have a condition for decentralized follow-up
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Diogo Moia, PharmD contact
Brazil3 sites, 3 recruiting
- Recruiting
Hospital Universitário João de Barros Barreto
Belém, Pará
Rita Sousa, MD-PhD
- Recruiting
Hospital Naval Marcílio Dias
Rio de Janeiro
Hemerson Luz, MD-PhD
- Recruiting
Hospital Israelita Albert Einstein
São Paulo, São Paulo
Lucas Theotônio, MD-PhD
About this study
Official title: Observational, Prospective, Cohort Study of Mpox Infection in Brazil - NETPOX Cohort
The study is a prospective cohort that evaluates the clinical and immune-metabolic variables that may be linked to the risk and severity of the infection or even hospitalization or death in patients infected with the Mpox virus in Brazil. The expectation is to include at least 80 patients over six months, with a follow-up of 90 days from inclusion, through contact via decentralized visits.
- Being tested
- Viral genomic, Untargeted Metabolomics
- Medical subject headings
- Mpox, Monkeypox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viral genomicDiagnostic test
Evaluation of mpox viral genomic
Untargeted MetabolomicsDiagnostic test
Evaluation of metabolomics of the total plasma, oropharynx, and skin samples.
| Study group | Role | What they receive |
|---|---|---|
| Human cases of monkeypox confirmed by PCR | Laboratory-confirmed mpox infection is defined as determined by polymerase chain reaction assay (PCR), culture, or antigen test obtained from a sample collected from blood, oropharynx, anal or skin lesion within 5 days of inclusion. Receives: Diagnostic Test: Viral genomic; Diagnostic Test: Untargeted Metabolomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composed of incidence of rash, fever, adenopathy, general pain, chills, weakness, occurrence of hospitalization, and neurological repercussions
symptoms' incidence in participants with mpox infection
Measured: Up to 90 days after the inclusion
Secondary outcomes (4)
Death
Incidence of death
Measured: Up to 90 days after the inclusion
Hospitalizations
Incidence of hospitalization
Measured: Days 15, 30, 60, and 90
Untargeted metabolomics of total plasmas and skin lesion
Changes among visits of Immune-metabolomics responses related to symptoms' incidence
Measured: Days 15, 30, 60, and 90
Viral genomic
Evaluation of the pattern of viral genome of the mpox virus circulation in Brazil
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start16 Jul 2024
- Primary completionJan 2025 (estimated)
- Study completionDec 2026 (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
- 80 participants (estimated)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Responsible party
- Sponsor
- Investigators
- Henrique Fonseca, Study chair, Hospital Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784038
- Sponsor's protocol ID
- NETPOX
- Status last verified
- Jun 2024
- First submitted
- 7 Mar 2023
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Prospective, Cohort Study of Mpox Infection in Brazil - NETPOX Cohort
- ClinicalTrials.gov ID
- NCT05784038
- Acronym / sponsor ID
- NETPOX
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Mar 2023 (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 study is a prospective cohort that evaluates the clinical and immune-metabolic variables that may be linked to the risk and severity of the infection or even hospitalization or death in patients infected with the Mpox virus in Brazil. The expectation is to include at least 80 patients over six months, with a follow-up of 90 days from inclusion, through contact via decentralized visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human cases of monkeypox confirmed by PCR | – | Diagnostic Test: Viral genomic, Diagnostic Test: Untargeted MetabolomicsLaboratory-confirmed mpox infection is defined as determined by polymerase chain reaction assay (PCR), culture, or antigen test obtained from a sample collected from blood, oropharynx, anal or skin lesion within 5 days of inclusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who have risk factors for mpox infection in Brazil.
Key inclusion criteria (2 listed)
- Men and women aged ≥ 18 years with confirmed MPOX infection.
- (laboratory-confirmed monkeypox infection is defined as determined by PCR, culture, or antigen test obtained from a sample collected from blood, oropharynx, anal or skin lesion within 4 days of randomization)
Key exclusion criteria (2 listed)
- Inability to provide informed consent;
- Patient who, judging by the study team, does not have a condition for decentralized follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Viral genomicEvaluation of mpox viral genomic | Diagnostic test | Human cases of monkeypox confirmed by PCR |
| Untargeted MetabolomicsEvaluation of metabolomics of the total plasma, oropharynx, and skin samples. | Diagnostic test | Human cases of monkeypox confirmed by PCR |
Primary outcome
Composed of incidence of rash, fever, adenopathy, general pain, chills, weakness, occurrence of hospitalization, and neurological repercussions
Time frame: Up to 90 days after the inclusion
symptoms' incidence in participants with mpox infection
4 secondary outcomes
Death
Time frame: Up to 90 days after the inclusion
Hospitalizations
Time frame: Days 15, 30, 60, and 90
Untargeted metabolomics of total plasmas and skin lesion
Time frame: Days 15, 30, 60, and 90
Viral genomic
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Diogo Moia, PharmD contact
Henrique Fonseca study chair
Hospital Albert Einstein
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 and MPOX, run by Hospital Israelita Albert Einstein at 3 sites in Brazil.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 17 Jul 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Henrique AR Fonseca, PhD (+5511968308958, henrique.fonseca@einstein.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composed of incidence of rash, fever, adenopathy, general pain, chills, weakness, occurrence of hospitalization, and neurological repercussions (time frame: Up to 90 days after the inclusion). 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 17 Jul 2024.