Pain-related Long Covid in Covid-19 Survivors

NCT ID: NCT05520931

Last Updated: 2023-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 600000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-03
• Study Completion Date: 2024-08-31

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.

Conditions

COVID-19; Pain, Chronic

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Hospitalization group

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.

Questionnaire and register-based data assessment

Intervention Type: OTHER

Primary data will be collected via a generic questionnaire from the two groups. Secondary data will consist of register-based socio-economic data and medical charts data collected from the Danish Health Data Authority and Denmark' Statistics.

PCR+ group

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.

Questionnaire and register-based data assessment

Intervention Type: OTHER

Primary data will be collected via a generic questionnaire from the two groups. Secondary data will consist of register-based socio-economic data and medical charts data collected from the Danish Health Data Authority and Denmark' Statistics.

Interventions

Questionnaire and register-based data assessment

Primary data will be collected via a generic questionnaire from the two groups. Secondary data will consist of register-based socio-economic data and medical charts data collected from the Danish Health Data Authority and Denmark' Statistics.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aalborg University

OTHER

Sponsor Role: lead

Responsible Party

Brian Duborg Ebbesen

PhD fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lars Arendt-Nielsen, Dr.med, PhD

Role: STUDY_DIRECTOR

North Denmark Region

Brian D Ebbesen, PhD student

Role: PRINCIPAL_INVESTIGATOR

North Denmark Region

Locations

The North Denmark Region

Aalborg, , Denmark

Countries

Denmark

Other Identifiers

2021-056227

Identifier Type: -

Identifier Source: org_study_id