NCT04701892

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

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
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

January 19, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

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.

    The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months

Secondary Outcomes (5)

  • Pressure pain thresholds

    The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months

  • Temporal summation

    The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months

  • Descending nociceptive inhibition

    The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months

  • Functionality and disability

    The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months

  • Functionality and disability

    The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months

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 before inclusion in the study. More specifically, only patients who had a positive COVID-19 test 2 to 8 weeks before study inclusion are eligible.

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
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 \> 8 weeks 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
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 8, 2021

Study Start

January 19, 2021

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

January 22, 2021

Record last verified: 2021-01

Locations

BE(1)