Covid19PRESTONCT04912778
Profiling of Post Covid-19 Infection Patients: an Online Survey
An observational study of Covid19, run by Moens Maarten at 1 site in Belgium.
Trial summary
The aim of this study is to explore the relation between indicators of central sensitisation, quality of life and functional status in patients post covid-19 infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Filling in an online survey
- How many people
- 567 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Jun 2021to 30 Aug 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: In this study male and female adults who were previously infected with covid-19 will be eligible to complete the survey. No specific criteria will be imposed regarding the time frame after infection.
Who may be able to join
- male and female adults who were previously infected with covid-19
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to explore the relation between indicators of central sensitisation, quality of life and functional status in patients post covid-19 infection.
- Conditions
- Covid19
- Being tested
- Filling in an online survey
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filling in an online surveyOther
Patients are asked to fill in an online survey regarding functional status, quality of life and symptoms of central sensitisation.
| Study group | Role | What they receive |
|---|---|---|
| Persons who had a covid-19 infection. | Male and female adults who were previously infected with covid-19. Receives: Other: Filling in an online survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional status
Post-COVID-19 functional status is evaluated by the Post-COVID-19 Functional Status Scale.
Measured: Up to 18 months after infection with Covid-19.
Health-related Quality of life
The EuroQol with five dimensions and three levels is used to evaluate health-related quality of life.
Measured: Up to 18 months after infection with Covid-19.
Symptoms of central sensitisation
Symptoms of central sensitisation are assessed by the Central Sensitization Inventory.
Measured: Up to 18 months after infection with Covid-19.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start4 Jun 2021
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 567 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moens Maarten
- Sponsor type
- University, hospital or other
- Collaborators
- STIMULUS research group, Vrije Universiteit Brussel
- Responsible party
- Sponsor-investigator, Moens Maarten, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912778
- Sponsor's protocol ID
- PRESTO
- Acronym
- PRESTO
- Status last verified
- Sep 2021
- First submitted
- 2 Jun 2021
- Last updated
- 23 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moens M, Duarte RV, De Smedt A, Putman K, Callens J, Billot M, Roulaud M, Rigoard P, Goudman L. Health-related quality of life in persons post-COVID-19 infection in comparison to normative controls and chronic pain patients. Front Public Health. 2022 Oct 20;10:991572. doi: 10.3389/fpubh.2022.991572. eCollection 2022.
PubMed 36339175
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profiling of Post Covid-19 Infection Patients: an Online Survey
- ClinicalTrials.gov ID
- NCT04912778
- Acronym / sponsor ID
- PRESTO / PRESTO
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 567 participants (actual)
- Lead sponsor
- Moens MaartenUniversity, hospital or other
- Collaborators
- STIMULUS research group, Vrije Universiteit Brussel
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 3 Jun 2021 (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 aim of this study is to explore the relation between indicators of central sensitisation, quality of life and functional status in patients post covid-19 infection.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons who had a covid-19 infection. | – | Other: Filling in an online surveyMale and female adults who were previously infected with covid-19. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this study male and female adults who were previously infected with covid-19 will be eligible to complete the survey. No specific criteria will be imposed regarding the time frame after infection.
Key inclusion criteria (1 listed)
- male and female adults who were previously infected with covid-19
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Filling in an online surveyPatients are asked to fill in an online survey regarding functional status, quality of life and symptoms of central sensitisation. | Other | Persons who had a covid-19 infection. |
Primary outcome
Functional status
Time frame: Up to 18 months after infection with Covid-19.
Post-COVID-19 functional status is evaluated by the Post-COVID-19 Functional Status Scale.
Health-related Quality of life
Time frame: Up to 18 months after infection with Covid-19.
The EuroQol with five dimensions and three levels is used to evaluate health-related quality of life.
Symptoms of central sensitisation
Time frame: Up to 18 months after infection with Covid-19.
Symptoms of central sensitisation are assessed by the Central Sensitization Inventory.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Derived from this study: PubMed 36339175Moens M, Duarte RV, De Smedt A, Putman K, Callens J, Billot M, Roulaud M, Rigoard P, Goudman L. Health-related quality of life in persons post-COVID-19 infection in comparison to normative controls and chronic pain patients. Front Public Health. 2022 Oct 20;10:991572. doi: 10.3389/fpubh.2022.991572. eCollection 2022.
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Covid19, run by Moens Maarten at 1 site in Belgium.
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 0 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: finished, as of the sponsor's last update on 23 Sep 2021. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional status (time frame: Up to 18 months after infection with Covid-19.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04912778, which also lists 1 linked publication.
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 23 Sep 2021.