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

NCT05002205 | Unknown

• 1 other identifier: S65768
• Study Type: observational
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Incidence of post-COVID symptoms

  6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID

• 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

• 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

Study Arms (2)

COVID-19

exposed cohort with a diagnosis of COVID-19 in the last 6 months

Other: Questionnaires; Other: spirometry; Other: ECG; Other: 1 minute sit to stand test; Other: Vital parameters

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; Other: spirometry; Other: ECG; Other: 1 minute sit to stand test; Other: Vital parameters

Interventions

Questionnaires OTHER

Participants will be followed up by means of online surveys and 2 study visits.

COVID-19; no history of COVID-19

spirometry OTHER

During two study visits, the lung function will be measured (FVC, FEV1)

COVID-19; no history of COVID-19

ECG OTHER

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

Also known as: elecrocardiogram

COVID-19; no history of COVID-19

1 minute sit to stand test OTHER

Physical endurance is tested during 2 study visits.

COVID-19; no history of COVID-19

Vital parameters OTHER

blood pressure, pulse, weight

COVID-19; no history of COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Aged 18 years or older;
• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KU Leuven: lead

MeSH Terms

Conditions

COVID-19

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Julie Domen, MD

CONTACT

016372917; julie.domen@kuleuven.be

Ann Van den Bruel, Prof MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: August 12, 2021
• Study Start: August 31, 2021
• Primary Completion: August 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 18, 2021

Record last verified: 2021-08