NCT04653857

Brief Summary

COVID-19 infection coud induce cardiac injuries. Before returning to sport, cardiac evaluation is recommended by sports federations, based on the precautionary principle and the opinion of expert consensus. The aim of this study is to to determine the prevalence of abnormalities in cardiological examinations realized in athletes who have suffered from COVID-19 infection, symptomatic or not.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

December 7, 2020

Status Verified

December 1, 2020

Enrollment Period

29 days

First QC Date

December 3, 2020

Last Update Submit

December 4, 2020

Conditions

Covid19

Keywords

High-level athleterecent COVID 19 infection, symptomatic or not

Outcome Measures

Primary Outcomes (1)

  • Prevalence of cardiac abnormality

    Prevalence of cardiac abnormality encountered during examinations performed in athletes before resuming intense sport, after infection with COVID-19

    1 to 3 weeks after COVID-19 infection

Secondary Outcomes (1)

  • Demographic variables

    1 to 3 weeks after COVID-19 infection

Study Arms (1)

High-level athlete who had a recent COVID 19 infection, symptomatic or not

High-level athlete who had a recent COVID 19 infection, symptomatic or not

Eligibility Criteria

Age10 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

High-level athlete (professionals or high-level ministerial list) who had a recent COVID 19 infection, symptomatic or not

You may qualify if:

  • High-level athlete
  • recent COVID 19 infection, symptomatic or not
  • evidence of COVID 19 infection by PCR or serology

You may not qualify if:

  • \- subject opposition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Stéphane CADE, MD

    Clinique du Millenaire, Montpellier, France

    PRINCIPAL INVESTIGATOR

  • Christophe HEDON, MD

    UH MONTPELLIER

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2020

First Posted

December 4, 2020

Study Start

April 1, 2020

Primary Completion

April 30, 2020

Study Completion

January 1, 2021

Last Updated

December 7, 2020

Record last verified: 2020-12

Locations

FR(1)