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
• Status: Enrolling by invitation
• 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
• 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)

Related Conditions & MeSH terms

• Chronic Pain
• COVID-19
• Pain, Chronic

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