COVID-19NCT05520931
Pain-related Long Covid in Covid-19 Survivors
An observational study of COVID-19 and Pain, Chronic, run by Aalborg University at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Pain, Chronic
- What is being tested?
- Questionnaire and register-based data assessment
- How many people
- 600,000 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Aug 2022to 31 Aug 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hospital group: All patients aged 18 or above that has been admittet to a hospitals in Denmark between 1st of Mach 2020 and 31st of December 2021. PCR+ group: All persons aged 18 or above that between 1st March 2020 and 31st of December 2021 have tested positive in a PCR test without hospital admission.
Who may be able to join
- Previously infected with SARS-CoV-2 virus
Who cannot join
- Participants under the age of 18
- Hidden/secret address/name
- No access to digital mail (the channel of data collection)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Questionnaire and register-based data assessment
- Keywords
- Covid-19, Coronavirus, Chronic Pain, Persistant pain, Long Covid, SARS-CoV-2
- Medical subject headings
- COVID-19, Chronic Pain, Coronavirus Infections, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and register-based data assessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaire and register-based data assessment | |
| 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. Receives: Other: Questionnaire and register-based data assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Above six months after a SARS-CoV-2 infection
Secondary outcomes (3)
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
Measured: Above six months after a SARS-CoV-2 infection
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
Measured: Above six months after a SARS-CoV-2 infection
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
Measured: Above six months after a SARS-CoV-2 infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start3 Aug 2022
- Primary completion1 Jul 2023
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 600,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Duborg Ebbesen, Aalborg University
- Investigators
- Lars Arendt-Nielsen, Dr.med, PhD, Study director, North Denmark RegionBrian D Ebbesen, PhD student, Principal investigator, North Denmark Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520931
- Sponsor's protocol ID
- 2021-056227
- Status last verified
- Aug 2023
- First submitted
- 29 Aug 2022
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain-related Long Covid in Covid-19 Survivors
- ClinicalTrials.gov ID
- NCT05520931
- Acronym / sponsor ID
- 2021-056227
- Conditions
- COVID-19, Pain, Chronic
- Keywords
- Covid-19, Coronavirus, Chronic Pain, Persistant pain, Long Covid, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600,000 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospitalization group | – | Other: Questionnaire and register-based data assessmentPreviously 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 | – | Other: Questionnaire and register-based data assessmentNon-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital group: All patients aged 18 or above that has been admittet to a hospitals in Denmark between 1st of Mach 2020 and 31st of December 2021. PCR+ group: All persons aged 18 or above that between 1st March 2020 and 31st of December 2021 have tested positive in a PCR test without hospital admission.
Key inclusion criteria (1 listed)
- Previously infected with SARS-CoV-2 virus
Key exclusion criteria (3 listed)
- Participants under the age of 18
- Hidden/secret address/name
- No access to digital mail (the channel of data collection)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire and register-based data assessmentPrimary 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. | Other | Hospitalization group, PCR+ group |
Primary outcome
Persistent pain in Covid-19 survivors
Time frame: 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
3 secondary outcomes
The role of comorbidities in the development of persistent pain in Covid-19 survivors
Time frame: Above six months after a SARS-CoV-2 infection
The role of comorbidities in the development of persistent pain in Covid-19 survivors II
Time frame: Above six months after a SARS-CoV-2 infection
The role of socio-economic impact on the development of persistent pain in Covid-19 survivors
Time frame: Above six months after a SARS-CoV-2 infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Arendt-Nielsen, Dr.med, PhD study director
North Denmark Region
Brian D Ebbesen, PhD student principal investigator
North Denmark Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Pain, Chronic, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent pain in Covid-19 survivors (time frame: Above six months after a SARS-CoV-2 infection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.