Covid19CoCoNCT05002205
Long-term Effects of COVID-19: a Comparative Cohort Study
An observational study of Covid19, run by KU Leuven.
Trial summary
This study is a longitudinal cohort study which investigates the effect of COVID-19 in ambulatory care. This study aims to assess the effect of COVID-19 beyond the acute phase, i.e. on long-term symptoms, respiratory and cardiovascular health, use of health services, and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Questionnaires, spirometry and ECG
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2021to 31 Dec 2023
- 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: 2 cohorts of people who experienced an infection in the past 6 months of which 1 group had a proven covid-19 infection and 1 group definitely did not.
Who may be able to join
- Participants eligible for inclusion in this study for the exposed cohort with a diagnosis of COVID-19 in the last 6 months must meet all of the following criteria:
- Aged 18 years or older;
- Positive result on a rapid Ag test or PCR for SARS-CoV-2 for Covid-19 compatible symptoms a maximum of 6 months before inclusion;
- Patient is community-dwelling;
- Participant or their proxy is willing and able to give informed consent for participation in this study;
- Participant is willing to comply with all study procedures.
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- Participants are sampled in the same practices as the exposed cohort and are eligible for inclusion in this study for the non-exposed without a diagnosis of COVID-19 in the last 6 months when they meet all of the following criteria:
- Aged 18 years or older;
- Tested because of suggestive symptoms with a rapid Ag test or PCR for SARS-CoV-2 at the same time (+/- 1 month) as the exposed cohort, of which the result was negative
- Patient is community-dwelling;
- Participant or their proxy is willing and able to give informed consent for participation in this study;
- Participant is willing to comply with all study procedures.
Who cannot join
- Participants eligible for the cohort with COVID-19 in the last 6 months must not meet any of the following criteria:
- Patients in palliative care;
- Patients for whom there is already someone from the same household participating;
- Judgement of the recruiting clinician deems participant ineligible.
- Participants eligible for the cohort without COVID-19 must not meet any of the following criteria:
- A positive test for a SARS-CoV-2 infection in the last 2 years;
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- Patients in palliative care;
- Patients for whom there is already someone from the same household participating;
- Judgement of the recruiting clinician deems participant ineligible.
- Prior vaccination against Covid-19 is not an exclusion criterion.
Trial locations and contacts
No sites are listed yet.
Ann Van den Bruel, Prof MD contact
About this study
This study is a longitudinal cohort study which investigates the effect of COVID-19 in ambulatory care. This study aims to assess the effect of COVID-19 beyond the acute phase, i.e. on long-term symptoms, respiratory and cardiovascular health, use of health services, and quality of life.
Read the detailed description
This study is a longitudinal cohort study comparing two cohorts. One cohort tested positive for SARS-CoV-2 and the other tested negative for SARS-CoV-2 matched by the timing of testing in the past 6 months. Participants will be observed for two years after their test for COVID-19 with online surveys at different time intervals and face-to-face follow-up visits.
- Conditions
- Covid19
- Being tested
- Questionnaires, spirometry, ECG, 1 minute sit to stand test, Vital parameters
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Participants will be followed up by means of online surveys and 2 study visits.
spirometryOther
During two study visits, the lung function will be measured (FVC, FEV1)
ECGOther
Also called elecrocardiogram
During two study visits, the presence of arrhythmia will be explored.
1 minute sit to stand testOther
Physical endurance is tested during 2 study visits.
Vital parametersOther
blood pressure, pulse, weight
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 | exposed cohort with a diagnosis of COVID-19 in the last 6 months Receives: Other: Questionnaires; Other: spirometry; Other: ECG; Other: 1 minute sit to stand test; Other: Vital parameters | |
| no history of COVID-19 | non-exposed cohort without a diagnosis of COVID-19. Tested for COVID-19 because of symptoms at the same time (+/- 1 month) as the exposed cohort. Receives: Other: Questionnaires; Other: spirometry; Other: ECG; Other: 1 minute sit to stand test; Other: Vital parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue severity 6 months after diagnosis of COVID-19.
Data for this endpoint are collected with a questionnaire during the first study visit at 6 months. The severity of fatigue will be assessed using the Fatigue Severity Scale (FSS). This is a 9-item scale which measures the severity of fatigue and how it affects a person's activities and lifestyle.
The score ranges from 7 to 63, with higher values indicating more fatigue.
Measured: 6 months post-COVID
Secondary outcomes (15)
Incidence of post-COVID symptoms
Incidence of each individual symptoms at 6 months, 9 months, 1 year, 1.5 years and 2 years including cough, difficulty breathing, tightness on the chest, pain in the lungs, throatache, muscle ache, muscle weakness, joint pain, pain between the shoulder blades, headache, dizziness, confusion, concentration loss/lack of focus, concentration problems on short and long term, feeling absent, difficulties finding words/afasia, palpitations, hot flushes, sleeping problems, abdominal pain, blurred vision, nerve pains, sensory disorders, mood swings, anxiety, depressive feeling (Source: questionnaire during study visits and remote surveys)
Measured: 6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID
Participants' quality of life
Euroqol EQ-5D-5L: The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems, where higher scores indicate a better outcome (Source: questionnaire during study visits and remote surveys)
Measured: 6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID
Lung function (FEV1, FVC)
(Source: spirometry during study visits at 6 months and 1 year)
Measured: 6 months and 1 year post-COVID
The degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4 (mMRC scale)
0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking ∼100 m or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing
Measured: 6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID
Gustatation
scale from 1 to 10; higher scores indicate more problems with gustation. (Source: questionnaires during study visits and remote surveys)
Measured: 6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID
Olfaction
scale from 1 to 10; higher scores indicate more problems with olfaction. (Source: questionnaires during study visits and remote surveys)
Measured: 6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID
Incidence of diagnoses of COPD
Source: spirometry during study visits
Measured: 6 months and 1 year post-COVID
Exercice capacity and endurance
Source: 1 minute sit to stand test during study visits
Measured: 6 months and 1 year post-COVID
Incidence of cardiovascular events including AMI, lung embolism of stroke
Questionnaire during study visits
Measured: 6 months and 1 year post-COVID
Number of Unplanned hospital admissions of at least 24 hours
Source: questionnaire during study visits and remote surveys
Measured: within 2 years post-COVID
Number of Visits to healthcare professionals
Source: questionnaire during study visits and remote surveys
Measured: within 2 years post-COVID
Number of days absent from work
Source: questionnaire during study visits and remote surveys
Measured: within 2 years post-COVID
Exploring treatments attempted by patients in the scope of post-COVID symptoms
Categorical options: no treatment; vitamines; antibiotics; puffs; pain medication; anti-inflammatory drugs; others Source: questionnaire during study visits and remote surveys
Measured: within 2 years post-COVID
Exploring the type of counseling patients with post-covid symptoms use.
Categorical options: no counseling; psychologist; physiotherapist; GP; rehabilitation doctor; other Source: questionnaire during study visits and remote surveys
Measured: within 2 years post-COVID
Exploring the meaning of fatigue post-COVID and its impact on their daily lives
Source: semi-structured interviews online
Measured: +/- 6 months post-COVID
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start31 Aug 2021 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Van den Bruel, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002205
- Sponsor's protocol ID
- S65768
- Acronym
- CoCo
- Status last verified
- Aug 2021
- First submitted
- 16 Jul 2021
- Last updated
- 18 Aug 2021
- 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 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of COVID-19: a Comparative Cohort Study
- ClinicalTrials.gov ID
- NCT05002205
- Acronym / sponsor ID
- CoCo / S65768
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 31 Aug 2021 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 12 Aug 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.
This study is a longitudinal cohort study which investigates the effect of COVID-19 in ambulatory care. This study aims to assess the effect of COVID-19 beyond the acute phase, i.e. on long-term symptoms, respiratory and cardiovascular health, use of health services, and quality of life.
Detailed description
This study is a longitudinal cohort study comparing two cohorts. One cohort tested positive for SARS-CoV-2 and the other tested negative for SARS-CoV-2 matched by the timing of testing in the past 6 months. Participants will be observed for two years after their test for COVID-19 with online surveys at different time intervals and face-to-face follow-up visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 | – | Other: Questionnaires, Other: spirometry, Other: ECG, Other: 1 minute sit to stand test, Other: Vital parametersexposed cohort with a diagnosis of COVID-19 in the last 6 months |
| no history of COVID-19 | – | Other: Questionnaires, Other: spirometry, Other: ECG, Other: 1 minute sit to stand test, Other: Vital parametersnon-exposed cohort without a diagnosis of COVID-19. Tested for COVID-19 because of symptoms at the same time (+/- 1 month) as the exposed cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 2 cohorts of people who experienced an infection in the past 6 months of which 1 group had a proven covid-19 infection and 1 group definitely did not.
Key inclusion criteria (12 listed)
- Participants eligible for inclusion in this study for the exposed cohort with a diagnosis of COVID-19 in the last 6 months must meet all of the following criteria:
- Aged 18 years or older;
- Positive result on a rapid Ag test or PCR for SARS-CoV-2 for Covid-19 compatible symptoms a maximum of 6 months before inclusion;
- Patient is community-dwelling;
- Participant or their proxy is willing and able to give informed consent for participation in this study;
Key exclusion criteria (10 listed)
- Participants eligible for the cohort with COVID-19 in the last 6 months must not meet any of the following criteria:
- Patients in palliative care;
- Patients for whom there is already someone from the same household participating;
- Judgement of the recruiting clinician deems participant ineligible.
- Participants eligible for the cohort without COVID-19 must not meet any of the following criteria:
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 |
|---|---|---|
| QuestionnairesParticipants will be followed up by means of online surveys and 2 study visits. | Other | COVID-19, no history of COVID-19 |
| spirometryDuring two study visits, the lung function will be measured (FVC, FEV1) | Other | COVID-19, no history of COVID-19 |
| ECGAlso: elecrocardiogramDuring two study visits, the presence of arrhythmia will be explored. | Other | COVID-19, no history of COVID-19 |
| 1 minute sit to stand testPhysical endurance is tested during 2 study visits. | Other | COVID-19, no history of COVID-19 |
| Vital parametersblood pressure, pulse, weight | Other | COVID-19, no history of COVID-19 |
Primary outcome
Fatigue severity 6 months after diagnosis of COVID-19.
Time frame: 6 months post-COVID
Data for this endpoint are collected with a questionnaire during the first study visit at 6 months. The severity of fatigue will be assessed using the Fatigue Severity Scale (FSS). This is a 9-item scale which measures the severity of fatigue and how it affects a person's activities and lifestyle. The score ranges from 7 to 63, with higher values indicating more fatigue.
15 secondary outcomes
Incidence of post-COVID symptoms
Time frame: 6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID
Participants' quality of life
Time frame: 6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID
Lung function (FEV1, FVC)
Time frame: 6 months and 1 year post-COVID
The degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4 (mMRC scale)
Time frame: 6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID
Gustatation
Time frame: 6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID
Olfaction
Time frame: 6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID
Incidence of diagnoses of COPD
Time frame: 6 months and 1 year post-COVID
Exercice capacity and endurance
Time frame: 6 months and 1 year post-COVID
Incidence of cardiovascular events including AMI, lung embolism of stroke
Time frame: 6 months and 1 year post-COVID
Number of Unplanned hospital admissions of at least 24 hours
Time frame: within 2 years post-COVID
Number of Visits to healthcare professionals
Time frame: within 2 years post-COVID
Number of days absent from work
Time frame: within 2 years post-COVID
Exploring treatments attempted by patients in the scope of post-COVID symptoms
Time frame: within 2 years post-COVID
Exploring the type of counseling patients with post-covid symptoms use.
Time frame: within 2 years post-COVID
Exploring the meaning of fatigue post-COVID and its impact on their daily lives
Time frame: +/- 6 months post-COVID
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- 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.
Ann Van den Bruel, Prof MD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by KU Leuven.
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 12 inclusion and 10 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 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Julie Domen, MD (016372917, julie.domen@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue severity 6 months after diagnosis of COVID-19. (time frame: 6 months post-COVID). 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 18 Aug 2021.