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

KU Leuven180 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

180

Conditions

Covid19

Interventions

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

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 6 months post-COVID

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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)

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)

Central Contacts

Julie Domen, MD

CONTACT

016372917 julie.domen@kuleuven.be

Ann Van den Bruel, Prof MD

CONTACT

Data from ClinicalTrials.gov

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