Pain-related Long Covid in Covid-19 Survivors

• Conditions: COVID-19; Pain, Chronic
• Interventions: Other: Questionnaire and register-based data assessment

• Registration Number: NCT05520931
• Lead Sponsor: Aalborg University

Brief Summary

The exploratory project aims to investigate the presence of pain as a long Covid-19 symptom in previously hospitalised patients and in non-hospitalised persons previously tested positive in a PCR test.

Detailed Description

The main objectives investigated will be to determine the general prevalence of pain symptoms In Covid-19 survivors, correlating and analysing the role of previously comorbidities in the development of pain symptom in Covid-19 survivors, and to understand the prevalence of pain related long Covid-19 symptoms for future characterisations. Hence, the projects main outcome will be to try to understand why som Covid-19 survivors develop persistant pain and others don't. Furthermore, the project plan to analyse gender and age differences, and data between Covid-19 waves as well as any possible association between pain prevalence and time after positive PCR-test.

Study Timeline

• Study Start: 2022-08-03
• Study First Submitted: 2022-08-29
• Study First Submitted QC: 2022-08-29
• Study First Posted: 2022-08-30
• Primary Completion: 2023-07-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-08
• Last Update Posted: 2023-08-09
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 600000

Inclusion Criteria

• Previously infected with SARS-CoV-2 virus

Exclusion Criteria

• Participants under the age of 18
• Hidden/secret address/name
• No access to digital mail (the channel of data collection)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hospitalization group	Questionnaire and register-based data assessment	Previously hospitalized Covid-19 survivors who have been admittet to the hospital with or because of SARS-CoV-2 infection. Time from infection date start is \> 6 months. The group is anticipated to encompass 2.182 privously hospitalized adult patients.
PCR+ group	Questionnaire and register-based data assessment	Non-hospitalized Covid-19 survivors that has previously testet positive in an Polymerase chain reaction test without being admittet to the hospital. Time from infection data start is \> 6 months. The group will include almost the total population of adults who have tested positive in a Polymerase Chain Reaction test. Those with secret adresses and those without access to digital mail (information channel of the questionnaire) will be excluded being approcimatelyh 7% of 650.000 possible participants. The group encompasses 593.741 participants.

Primary Outcome Measures

Name	Time	Method
Persistent pain in Covid-19 survivors	Above six months after a SARS-CoV-2 infection	Detection of possible differences in Covid-19 survivors with or without persistent pain after a SARS-CoV-2 infection as collected via questionnaire data

Secondary Outcome Measures

Name	Time	Method
The role of comorbidities in the development of persistent pain in Covid-19 survivors II	Above six months after a SARS-CoV-2 infection	Register-based data about positive PCR-test correlated with self-reported pain from the questionnaire data
The role of comorbidities in the development of persistent pain in Covid-19 survivors	Above six months after a SARS-CoV-2 infection	Register-based medical charts from hospitalization correlated with self-reported pain from the questionnaire data
The role of socio-economic impact on the development of persistent pain in Covid-19 survivors	Above six months after a SARS-CoV-2 infection	Register-based data of socio-economic variables that could influence self-rated perception of pain

Trial Locations

Locations (1)

The North Denmark Region; 🇩🇰 Aalborg, Denmark