Observational, Prospective, Cohort Study of Mpox Infection in Brazil (NETPOX)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Monkeypox; MPOX
• Intervention / Treatment: Diagnostic test: Viral genomic; Diagnostic test: Untargeted Metabolomics

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Henrique AR Fonseca, PhD; Phone Number: +5511968308958; Email: henrique.fonseca@einstein.br
• Study Contact Backup: Name: Diogo Moia, PharmD; Email: diogo.moia@einstein.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals who have risk factors for mpox infection in Brazil.

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Inability to provide informed consent;
• Patient who, judging by the study team, does not have a condition for decentralized follow-up

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Viral genomic; Evaluation of mpox viral genomic; Diagnostic test: Untargeted Metabolomics; Evaluation of metabolomics of the total plasma, oropharynx, and skin samples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composed of incidence of rash, fever, adenopathy, general pain, chills, weakness, occurrence of hospitalization, and neurological repercussions	symptoms' incidence in participants with mpox infection	Up to 90 days after the inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Incidence of death	Up to 90 days after the inclusion
Hospitalizations	Incidence of hospitalization	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	Days 15, 30, 60, and 90
Viral genomic	Evaluation of the pattern of viral genome of the mpox virus circulation in Brazil	Day 0

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Collaborators: Ministry of Health, Brazil
• Investigators: Study Chair: Henrique Fonseca, Hospital Albert Einstein

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Poxviridae Infections; Monkeypox
• Other Study ID Numbers: NETPOX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No