NCT04703452

Brief Summary

The aim of this study is to evaluate whether there are indicators of central sensitisation in patients post covid-19 infection.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

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

First Submitted

Initial submission to the registry

January 7, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

January 19, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

12 months

First QC Date

January 7, 2021

Last Update Submit

January 20, 2021

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • Symptoms of Central Sensitisation

    Symptoms of central sensitisation will be measured with the Central Sensitization Inventory.

    Once, at the moment of the study visit.

Secondary Outcomes (5)

  • Pressure pain thresholds

    Once, at the moment of the study visit.

  • Temporal summation

    Once, at the moment of the study visit.

  • Descending nociceptive inhibition

    Once, at the moment of the study visit.

  • Functionality and disability

    Once, at the moment of the study visit.

  • Functionality and disability

    Once, at the moment of the study visit.

Study Arms (1)

Covid-19 infected patients

In this study male and female patients who were previously infected with covid-19 will be included. Patients will only be eligible if they had a positive covid-19 test at least 6 months before inclusion in the study.

Other: Indicators of central sensitisation

Interventions

Indicators of central sensitisationOTHER

Indicators of central sensitisation, assessed by the Central Sensitization Inventory

Covid-19 infected patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male and female patients who were previously infected with covid-19.

You may qualify if:

  • Cognitive and language functioning enabling coherent communication between the researcher and the participant.
  • French-or Dutch speaking persons.

You may not qualify if:

  • Covid-19 infection \< 6 months ago.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Marc Schiltz, MD

CONTACT

+32 2 477 60 20marc.schiltz@uzbrussel.be

Study Design

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

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 11, 2021

Study Start

January 19, 2021

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

January 22, 2021

Record last verified: 2021-01

Locations

BE(1)