Clinical trial NCT05002205: Long-term Effects of COVID-19: a Comparative Cohort Study
Official title: Long-term Effects of COVID-19: a Comparative Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fatigue severity 6 months after diagnosis of COVID-19.
timeFrame: 6 months post-COVID
Secondary outcomes:
measure: Incidence of post-COVID symptoms
timeFrame: 6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID
measure: Participants' quality of life
timeFrame: 6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID
measure: Lung function (FEV1, FVC)
timeFrame: 6 months and 1 year post-COVID
measure: The degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4 (mMRC scale)
timeFrame: 6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID
measure: Gustatation
timeFrame: 6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID
measure: Olfaction
timeFrame: 6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID
measure: Incidence of diagnoses of COPD
timeFrame: 6 months and 1 year post-COVID
measure: Exercice capacity and endurance
timeFrame: 6 months and 1 year post-COVID
measure: Incidence of cardiovascular events including AMI, lung embolism of stroke
timeFrame: 6 months and 1 year post-COVID
measure: Number of Unplanned hospital admissions of at least 24 hours
timeFrame: within 2 years post-COVID
measure: Number of Visits to healthcare professionals
timeFrame: within 2 years post-COVID
measure: Number of days absent from work
timeFrame: within 2 years post-COVID
measure: Exploring treatments attempted by patients in the scope of post-COVID symptoms
timeFrame: within 2 years post-COVID
measure: Exploring the type of counseling patients with post-covid symptoms use.
timeFrame: within 2 years post-COVID
measure: Exploring the meaning of fatigue post-COVID and its impact on their daily lives
timeFrame: +/- 6 months post-COVID
Other outcomes:
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