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

• Conditions: Covid19
• Interventions: Other: Questionnaires; Other: spirometry; Other: ECG; Other: 1 minute sit to stand test; Other: Vital parameters

• Registration Number: NCT05002205
• Lead Sponsor: KU Leuven

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 Timeline

• Study First Submitted: 2021-07-16
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-11
• Study First Posted: 2021-08-12
• Last Update Submitted: 2021-08-12
• Last Update Posted: 2021-08-18
• Study Start: 2021-08-31
• Primary Completion: 2023-08-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19	ECG	exposed cohort with a diagnosis of COVID-19 in the last 6 months
no history of COVID-19	ECG	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.
COVID-19	Questionnaires	exposed cohort with a diagnosis of COVID-19 in the last 6 months
COVID-19	spirometry	exposed cohort with a diagnosis of COVID-19 in the last 6 months
no history of COVID-19	1 minute sit to stand test	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.
no history of COVID-19	Vital parameters	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.
COVID-19	Vital parameters	exposed cohort with a diagnosis of COVID-19 in the last 6 months
COVID-19	1 minute sit to stand test	exposed cohort with a diagnosis of COVID-19 in the last 6 months
no history of COVID-19	Questionnaires	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.
no history of COVID-19	spirometry	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.

Primary Outcome Measures

Name	Time	Method
Fatigue severity 6 months after diagnosis of COVID-19.	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 Outcome Measures

Name	Time	Method
Participants' quality of life	6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID	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)
Lung function (FEV1, FVC)	6 months and 1 year post-COVID	(Source: spirometry during study visits at 6 months and 1 year)
Exploring treatments attempted by patients in the scope of post-COVID symptoms	within 2 years post-COVID	Categorical options: no treatment; vitamines; antibiotics; puffs; pain medication; anti-inflammatory drugs; others Source: questionnaire during study visits and remote surveys
Incidence of cardiovascular events including AMI, lung embolism of stroke	6 months and 1 year post-COVID	Questionnaire during study visits
Incidence of post-COVID symptoms	6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID	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)
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	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
Gustatation	6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID	scale from 1 to 10; higher scores indicate more problems with gustation. (Source: questionnaires during study visits and remote surveys)
Olfaction	6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID	scale from 1 to 10; higher scores indicate more problems with olfaction. (Source: questionnaires during study visits and remote surveys)
Incidence of diagnoses of COPD	6 months and 1 year post-COVID	Source: spirometry during study visits
Number of days absent from work	within 2 years post-COVID	Source: questionnaire during study visits and remote surveys
Exercice capacity and endurance	6 months and 1 year post-COVID	Source: 1 minute sit to stand test during study visits
Number of Unplanned hospital admissions of at least 24 hours	within 2 years post-COVID	Source: questionnaire during study visits and remote surveys
Number of Visits to healthcare professionals	within 2 years post-COVID	Source: questionnaire during study visits and remote surveys
Exploring the type of counseling patients with post-covid symptoms use.	within 2 years post-COVID	Categorical options: no counseling; psychologist; physiotherapist; GP; rehabilitation doctor; other Source: questionnaire during study visits and remote surveys
Exploring the meaning of fatigue post-COVID and its impact on their daily lives	+/- 6 months post-COVID	Source: semi-structured interviews online