Long-term Effects of COVID-19: a Comparative Cohort Study

NCT ID: NCT05002205

Last Updated: 2021-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-31

Study Completion Date

2023-12-31

Brief Summary

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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

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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

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Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19

exposed cohort with a diagnosis of COVID-19 in the last 6 months

Questionnaires

Intervention Type OTHER

Participants will be followed up by means of online surveys and 2 study visits.

spirometry

Intervention Type OTHER

During two study visits, the lung function will be measured (FVC, FEV1)

ECG

Intervention Type OTHER

During two study visits, the presence of arrhythmia will be explored.

1 minute sit to stand test

Intervention Type OTHER

Physical endurance is tested during 2 study visits.

Vital parameters

Intervention Type OTHER

blood pressure, pulse, weight

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.

Questionnaires

Intervention Type OTHER

Participants will be followed up by means of online surveys and 2 study visits.

spirometry

Intervention Type OTHER

During two study visits, the lung function will be measured (FVC, FEV1)

ECG

Intervention Type OTHER

During two study visits, the presence of arrhythmia will be explored.

1 minute sit to stand test

Intervention Type OTHER

Physical endurance is tested during 2 study visits.

Vital parameters

Intervention Type OTHER

blood pressure, pulse, weight

Interventions

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Questionnaires

Participants will be followed up by means of online surveys and 2 study visits.

Intervention Type OTHER

spirometry

During two study visits, the lung function will be measured (FVC, FEV1)

Intervention Type OTHER

ECG

During two study visits, the presence of arrhythmia will be explored.

Intervention Type OTHER

1 minute sit to stand test

Physical endurance is tested during 2 study visits.

Intervention Type OTHER

Vital parameters

blood pressure, pulse, weight

Intervention Type OTHER

Other Intervention Names

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elecrocardiogram

Eligibility Criteria

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Inclusion Criteria

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:

1. Aged 18 years or older;
2. 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;
3. Patient is community-dwelling;
4. Participant or their proxy is willing and able to give informed consent for participation in this study;
5. Participant is willing to comply with all study procedures.

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:

1. Aged 18 years or older;
2. 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
3. Patient is community-dwelling;
4. Participant or their proxy is willing and able to give informed consent for participation in this study;
5. Participant is willing to comply with all study procedures.

Exclusion Criteria

Participants eligible for the cohort with COVID-19 in the last 6 months must not meet any of the following criteria:

1. Patients in palliative care;
2. Patients for whom there is already someone from the same household participating;
3. Judgement of the recruiting clinician deems participant ineligible.

Participants eligible for the cohort without COVID-19 must not meet any of the following criteria:

1. A positive test for a SARS-CoV-2 infection in the last 2 years;
2. Patients in palliative care;
3. Patients for whom there is already someone from the same household participating;
4. Judgement of the recruiting clinician deems participant ineligible.

Prior vaccination against Covid-19 is not an exclusion criterion.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Ann Van den Bruel

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Julie Domen, MD

Role: CONTACT

016372917

Ann Van den Bruel, Prof MD

Role: CONTACT

Other Identifiers

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S65768

Identifier Type: -

Identifier Source: org_study_id

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