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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Covid19
• Intervention / Treatment: Other: Questionnaires; Other: spirometry; Other: ECG; Other: 1 minute sit to stand test; Other: Vital parameters

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 Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

• Study Contact: Name: Julie Domen, MD; Phone Number: 016372917; Email: julie.domen@kuleuven.be
• Study Contact Backup: Name: Ann Van den Bruel, Prof MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19; exposed cohort with a diagnosis of COVID-19 in the last 6 months	Other: Questionnaires; Participants will be followed up by means of online surveys and 2 study visits.; Other: spirometry; During two study visits, the lung function will be measured (FVC, FEV1); Other: ECG; During two study visits, the presence of arrhythmia will be explored.; Other Names: elecrocardiogram; Other: 1 minute sit to stand test; Physical endurance is tested during 2 study visits.; Other: Vital parameters; blood pressure, pulse, weight
no history of COVID-19; 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.	Other: Questionnaires; Participants will be followed up by means of online surveys and 2 study visits.; Other: spirometry; During two study visits, the lung function will be measured (FVC, FEV1); Other: ECG; During two study visits, the presence of arrhythmia will be explored.; Other Names: elecrocardiogram; Other: 1 minute sit to stand test; Physical endurance is tested during 2 study visits.; Other: Vital parameters; blood pressure, pulse, weight

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Lung function (FEV1, FVC)	(Source: spirometry during study visits at 6 months and 1 year)	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)	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
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
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
Incidence of diagnoses of COPD	Source: spirometry during study visits	6 months and 1 year post-COVID
Exercice capacity and endurance	Source: 1 minute sit to stand test during study visits	6 months and 1 year post-COVID
Incidence of cardiovascular events including AMI, lung embolism of stroke	Questionnaire during study visits	6 months and 1 year post-COVID
Number of Unplanned hospital admissions of at least 24 hours	Source: questionnaire during study visits and remote surveys	within 2 years post-COVID
Number of Visits to healthcare professionals	Source: questionnaire during study visits and remote surveys	within 2 years post-COVID
Number of days absent from work	Source: questionnaire during study visits and remote surveys	within 2 years post-COVID
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
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
Exploring the meaning of fatigue post-COVID and its impact on their daily lives	Source: semi-structured interviews online	+/- 6 months post-COVID

Collaborators and Investigators

• Sponsor: KU Leuven

Study record dates

Study Major Dates

• Study Start (Anticipated): August 31, 2021
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 16, 2021
• First Submitted That Met QC Criteria: August 11, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 12, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: S65768

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No