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NCT05520931 Clinical Trial

Pain-related Long Covid in Covid-19 Survivors

COVID-19 Clinical Trial

Official title:
Pain-related Long Covid in Covid-19 Survivors

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05520931
Other study ID # 2021-056227
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date August 3, 2022
Est. completion date August 31, 2024

Study information
Verified date August 2023
Source Aalborg University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 600000
Est. completion date August 31, 2024
Est. primary completion date July 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• 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.

Locations
Country Name City State
Denmark The North Denmark Region Aalborg

Sponsors (1)
Lead Sponsor Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Persistent pain in Covid-19 survivors Detection of possible differences in Covid-19 survivors with or without persistent pain after a SARS-CoV-2 infection as collected via questionnaire data Above six months after a SARS-CoV-2 infection
Secondary The role of comorbidities in the development of persistent pain in Covid-19 survivors Register-based medical charts from hospitalization correlated with self-reported pain from the questionnaire data Above six months after a SARS-CoV-2 infection
Secondary The role of comorbidities in the development of persistent pain in Covid-19 survivors II Register-based data about positive PCR-test correlated with self-reported pain from the questionnaire data Above six months after a SARS-CoV-2 infection
Secondary The role of socio-economic impact on the development of persistent pain in Covid-19 survivors Register-based data of socio-economic variables that could influence self-rated perception of pain Above six months after a SARS-CoV-2 infection
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