NCT05002205UnknownNot Applicable
Long-term Effects of COVID-19: a Comparative Cohort Study
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- KU Leuven
- Enrollment
- 180
- Primary Endpoint
- Fatigue severity 6 months after diagnosis of COVID-19.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •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.
- •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.
Exclusion Criteria
- •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;
- •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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Participants' quality of life(6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID)
- Lung function (FEV1, FVC)(6 months and 1 year post-COVID)
- Exploring treatments attempted by patients in the scope of post-COVID symptoms(within 2 years post-COVID)
- Incidence of post-COVID symptoms(6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID)
- The degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4 (mMRC scale)(6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID)
- Gustatation(6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID)
- Olfaction(6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID)
- Incidence of diagnoses of COPD(6 months and 1 year post-COVID)
- Number of days absent from work(within 2 years post-COVID)
- Exercice capacity and endurance(6 months and 1 year post-COVID)
- Incidence of cardiovascular events including AMI, lung embolism of stroke(6 months and 1 year post-COVID)
- Number of Unplanned hospital admissions of at least 24 hours(within 2 years post-COVID)
- Number of Visits to healthcare professionals(within 2 years post-COVID)
- Exploring the type of counseling patients with post-covid symptoms use.(within 2 years post-COVID)
- Exploring the meaning of fatigue post-COVID and its impact on their daily lives(+/- 6 months post-COVID)
Investigators
Ann Van den Bruel
Associate professor
KU Leuven
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