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

Covid19 Clinical Trial

— CoCo  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05002205
• Other study ID #: S65768
• Status: Not yet recruiting
• Start date: August 31, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2021
• Source: KU Leuven
• Contact: Julie Domen, MD
• Phone: 016372917
• Email: julie.domen[@]kuleuven.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: December 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19

Intervention

Other:
• Questionnaires
Participants will be followed up by means of online surveys and 2 study visits.
• spirometry
During two study visits, the lung function will be measured (FVC, FEV1)
• ECG
During two study visits, the presence of arrhythmia will be explored.
• 1 minute sit to stand test
Physical endurance is tested during 2 study visits.
• Vital parameters
blood pressure, pulse, weight

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months post-COVID
Secondary	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)	6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID
Secondary	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)	6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID
Secondary	Lung function (FEV1, FVC)	(Source: spirometry during study visits at 6 months and 1 year)	6 months and 1 year post-COVID
Secondary	The degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4 (mMRC scale)	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	6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID
Secondary	Gustatation	scale from 1 to 10; higher scores indicate more problems with gustation. (Source: questionnaires during study visits and remote surveys)	6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID
Secondary	Olfaction	scale from 1 to 10; higher scores indicate more problems with olfaction. (Source: questionnaires during study visits and remote surveys)	6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID
Secondary	Incidence of diagnoses of COPD	Source: spirometry during study visits	6 months and 1 year post-COVID
Secondary	Exercice capacity and endurance	Source: 1 minute sit to stand test during study visits	6 months and 1 year post-COVID
Secondary	Incidence of cardiovascular events including AMI, lung embolism of stroke	Questionnaire during study visits	6 months and 1 year post-COVID
Secondary	Number of Unplanned hospital admissions of at least 24 hours	Source: questionnaire during study visits and remote surveys	within 2 years post-COVID
Secondary	Number of Visits to healthcare professionals	Source: questionnaire during study visits and remote surveys	within 2 years post-COVID
Secondary	Number of days absent from work	Source: questionnaire during study visits and remote surveys	within 2 years post-COVID
Secondary	Exploring treatments attempted by patients in the scope of post-COVID symptoms	Categorical options: no treatment; vitamines; antibiotics; puffs; pain medication; anti-inflammatory drugs; others Source: questionnaire during study visits and remote surveys	within 2 years post-COVID
Secondary	Exploring the type of counseling patients with post-covid symptoms use.	Categorical options: no counseling; psychologist; physiotherapist; GP; rehabilitation doctor; other Source: questionnaire during study visits and remote surveys	within 2 years post-COVID
Secondary	Exploring the meaning of fatigue post-COVID and its impact on their daily lives	Source: semi-structured interviews online	+/- 6 months post-COVID