No registrations found.
ID
Source
Brief title
Health condition
COVID-19
Sponsors and support
Intervention
Outcome measures
Primary outcome
• To determine the cumulative incidence of SARS-CoV-2 (re)infection, measured by semi-quantitative real-time reverse transcriptase PCR (sqRT-PCR) in PSPs with self-reported symptoms suspected for COVID-19 during follow-up.
Secondary outcome
• To determine the cumulative incidence and duration of hospital admission during follow-up.
• To determine the cumulative incidence of death during follow-up.
• To determine the genetic relatedness of SARS-CoV-2 in PSPs with an epidemiological link.
Background summary
Rationale: Since December 2019, the world has been in the grip of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the disease it causes, coronavirus disease 2019 (COVID-19). Effective management of this pandemic requires estimation of the burden of disease. Currently available literature on COVID-19 mostly represents severe cases admitted to the hospital; data on mild and unsuspected clinical presentations and asymptomatic infections are largely unknown. In professional soccer direct physical contact is part of daily activities. It is unknown whether this is associated with an increased rate of transmission. To determine if there is excessive risk to professional soccer players we propose an observational study.
Objective: Primary objective: to determine the cumulative incidence of SARS-CoV-2 (re)infection, measured by semi-quantitative real-time reverse transcriptase PCR (sqRT-PCR) in PSPs with self-reported symptoms suspected for COVID-19 during follow-up; to determine the genetic relatedness of viruses when more than one PSP in a club is affected.
Study design: Cross-sectional study with prospective follow-up.
Study population: PSPs and active staff members employed by one of the participating soccer clubs.
Intervention: Not applicable.
Main study endpoints: Primary endpoint: sqRT-PCR-confirmed SARS-CoV-2 infection, self-reported symptoms suspected for COVID-19, hospital admission, death and genetic relatedness of SARS-CoV-2 RNA of PSPs with an epidemiological link.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation in this observational study poses a negligible risk and the burden is considered minimal. In case of self-reported symptoms suspected for COVID-19 during the follow-up, a nasopharyngeal/throat swab will be obtained. A retrospective questionnaire will be administered at enrolment and 12 weekly short questionnaires during follow-up. In case of self-reported symptoms suspected for COVID-19, a diary on symptoms will be kept until the resolution of symptoms. There is no direct benefit to subjects, except that individual test results will be made available to the subject during and after the end of the study.
Study objective
Contactsports may increase the risk for transmission of COVID-19
Study design
Baseline 18 may 2020 - 31 may 2020 follow up 3 months last timepoint 31 August 2020
Intervention
none
Inclusion criteria
A subject who meets all of the following criteria will be eligible to participate in this study:
• PSPs and staff members in one of the participating soccer clubs
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Age below 18 years
• Direct involvement in the design or execution of this study
• Legally incapacitated or unwilling to provide informed consent
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8685 |
| Other | MEC-United : W20.108 |