- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04794985
Post-COVID-Health Study: Multidimensional Health Status of COVID-19 Survivors One Year After a SARS-CoV-2 Infection
Study Overview
Status
Conditions
Detailed Description
Rationale: Within the Netherlands, more than 1 million people have been infected with SARS-CoV-2, also known as COVID-19. Although the mortality rate is considerable, the vast majority of COVID-19 patients survive the infection. Preliminary findings show that a majority of COVID-19 survivors still experience health problems 3 months after the infection, including reduced lung diffusion capacity, low exercise capacity, muscle weakness, mental problems and reduced cognitive function resulting in a generally poor health status. Whether these health consequences persist on the long-term is unknown.
Objective: To assess the multidimensional health status of COVID-19 survivors one-year post-infection using validated subjective and objective measures.
Study design: A multicenter prospective observational study performed within the MUMC+ and VieCuri Medical Center.
Study population: 200 COVID-19 survivors of the MUMC+, VieCuri Medical Center or Zuyderland Medical Center, both hospitalized (ICU and non-ICU admitted) as well as non-hospitalized patients.
Main study parameters/endpoints: Outcome parameters include objectively and subjectively measured multidimensional health outcomes including physiological and metabolic health, physical capability, cognitive function, psychosocial well-being, social well-being, patient reported outcomes as well as potential determinants of these multidimensional health outcomes (e.g. treatment during/after SARS-CoV-2 infection, vaccination, comorbidities, medication use etc.). Outcomes will be measured during a one-day study visit.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will benefit from participating within this study, because their general health will be evaluated in detail and from a multidimensional perspective. Furthermore, subjects will be informed on their multidimensional health outcomes and will receive a lifestyle advice tailored to their health status. Risks and inconveniences are limited to the time investment associated with the completion of the questionnaires and the study visit. During the study visit various non-invasive measurements as well as minor invasive blood sampling will be performed.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Rosanne Beijers, PhD
- Phone Number: +31433882990
- Email: r.beijers@maastrichtuniversity.nl
Study Contact Backup
- Name: Harry Gosker, PhD
- Phone Number: +31433884298
- Email: h.gosker@maastrichtuniversity.nl
Study Locations
-
-
-
Heerlen, Netherlands, 6419
- Not yet recruiting
- Zuyderland Medical Center
-
Contact:
- Martijn de Kruif, Phd, MD
- Email: m.dekruif@zuderland.nl
-
Maastricht, Netherlands, 6229 HX
- Recruiting
- Maastricht University Medical Center
-
Contact:
- Rosanne Beijers, PhD
- Email: r.beijers@maastrichtuniversity.nl
-
Venlo, Netherlands, 5912 BL
- Recruiting
- Viecuri Medical Center
-
Contact:
- Frits van Osch, PhD
- Email: fvosch@viecuri.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
COVID-19 positive based on:
- Confirmed RT-PCR;
- Proven serology for SARS-COV-2 with clearly associated complaints for a SARS-COV-2 infection;
- CO-RADS score of 4 or more with a proven serology for SARS-CoV-2 afterwards.
- Age of ≥18 years;
- Able to provide informed consent;
- Understanding of Dutch language.
Exclusion Criteria:
- Patients not willing to participate;
- Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung function measured with spirometry
Time Frame: 1 year post-infection
|
Pre- and post-bronchodilator spirometry will be performed to determine forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1).
|
1 year post-infection
|
Diffusion capacity measured with the single breath method
Time Frame: 1 year post-infection
|
To determine diffusion capacity for carbon monoxide
|
1 year post-infection
|
(Persistent) lung damage
Time Frame: 1 year post-infection
|
To determine lung damage a chest CT-scan will be obtained.
To evaluate whether lung damage is persistent, scans will be compared to scans obtained during COVID-19 screening or COVID-19 after care.
|
1 year post-infection
|
Bone mineral density by dual-energy X-ray (DEXA)-scan
Time Frame: 1 year post-infection
|
Total bone mineral density (BMD) as well as BMD of the lumbar spine and total hip-neck will be determined using a DEXA-scan.
|
1 year post-infection
|
Lean mass by dual-energy X-ray (DEXA)-scan
Time Frame: 1 year post-infection
|
Total lean mass will be determined using a DEXA-scan.
|
1 year post-infection
|
Fat free mass by dual-energy X-ray (DEXA)-scan
Time Frame: 1 year post-infection
|
Total fat free mass will be measured using a DEXA-scan.
|
1 year post-infection
|
Fat mass by dual-energy X-ray (DEXA)-scan
Time Frame: 1 year post-infection
|
Total fat mass and fat percentage as well as visceral fat mass will be measured using a DEXA-scan.
|
1 year post-infection
|
Vertebral fracture assessment by dual-energy X-ray (DEXA-scan)
Time Frame: 1 year post-infection
|
Vertebral fracture assessment will be determined using a DEXA-scan.
|
1 year post-infection
|
Muscle cross sectional area on chest CT-scan
Time Frame: 1 year post-infection
|
Muscle cross sectional area will be determined based on pre-established Hounsfield Units on the chest CT-scan.
|
1 year post-infection
|
Adipose tissue cross sectional area on chest CT-scan
Time Frame: 1 year post-infection
|
Muscle cross sectional area will be determined based on pre-established Hounsfield Units on the chest CT-scan.
|
1 year post-infection
|
Weight will be measured on a weighing scale
Time Frame: 1 year post-infection
|
Weight will be measured on a weighing scale.
|
1 year post-infection
|
Height will be measured using a stadiometer
Time Frame: 1 year post-infection
|
Height will be measured using a stadiometer.
|
1 year post-infection
|
Body mass index (BMI) will be calculated from the weight and height
Time Frame: 1 year post-infection
|
Weight and height will be combined to report BMI in (kg/m^2)
|
1 year post-infection
|
Fasted resting energy expenditure by indirect calorimetry (ventilated hood)
Time Frame: 1 year post-infection
|
VO2 and VCO2 will be measured to determine energy expenditure.
|
1 year post-infection
|
Resting blood pressure
Time Frame: 1 year post-infection
|
Resting diastolic and systolic blood pressure will be measured as part of the cardiometabolic profile to determine the prevalence of the metabolic syndrome.
|
1 year post-infection
|
Waist circumference
Time Frame: 1 year post-infection
|
Waist circumference will be measured as part of the cardiometabolic profile to determine the prevalence of the metabolic syndrome.
|
1 year post-infection
|
Fasting glucose levels
Time Frame: 1 year post-infection
|
Fasting glucose levels will be determined in sampled blood as part of the cardiometabolic profile to determine the prevalence of the metabolic syndrome.
|
1 year post-infection
|
Fasted lipid profile
Time Frame: 1 year post-infection
|
Fasted high-density, low-density and total lipoprotein levels (HDL and LDL) as well as triglycerides will be measured as part of the cardiometabolic profile to determine the prevalence of the metabolic syndrome.
|
1 year post-infection
|
Six minute walking test to determine exercise capacity
Time Frame: 1 year post-infection
|
Six minute walking distance will be determined.
|
1 year post-infection
|
Peak work rate by cardiopulmonary cycling exercise test (CPET)
Time Frame: 1 year post-infection
|
Maximal work rate (W) will be determined during the CPET
|
1 year post-infection
|
Peak O2-consumption and CO2-production by cardiopulmonary cycling exercise test (CPET)
Time Frame: 1 year post-infection
|
Maximal O2 consumption and CO2 production will be determined during the CPET.
|
1 year post-infection
|
Maximal heart rate during cardiopulmonary cycling exercise test (CPET)
Time Frame: 1 year post-infection
|
Maximal heart will be measured during the CPET.
|
1 year post-infection
|
Respiratory muscle strength by mouth pressure
Time Frame: 1 year post-infection
|
Inspiratory and expiratory mouth pressure will be measured.
|
1 year post-infection
|
Upper extremity muscle strength by measuring handgrip strength
Time Frame: 1 year post-infection
|
A hydraulic grip strength dynamometer will be used to measure the maximal handgrip strength.
|
1 year post-infection
|
Lower extremity muscle strength by measuring isometric muscle strength
Time Frame: 1 year post-infection
|
Maximal isometric upper leg muscle strength will be measured of the quadriceps muscle using a Biodex dynamometer.
|
1 year post-infection
|
Mobility using the short physical performance battery (SPPB)
Time Frame: 1 year post-infection
|
The SPPB consists of three types of physical maneuvers: the balance test, the gait speed test and the chair stand test leading to a score of 0-12.
Lower scores indicate less mobility.
|
1 year post-infection
|
Physical activity level by accelerometry
Time Frame: 1 year post-infection
|
An accelerometer will be worn for 7 days to determine physical activity level.
|
1 year post-infection
|
Cognitive function by Montreal Cognitive Assessment (MOCA)
Time Frame: 1 year post-infection
|
The MOCA will lead to a total score of 0-30, in which lower scores indicate less cognitive function.
|
1 year post-infection
|
Cognitive function using the cognitive failure questionnaire (CFQ)
Time Frame: 1 year post-infection
|
The CFQ will lead to a total score of 0-100.
A higher total score indicates more subjective cognitive failure.
Additionally, four subscales can be identified, related to distraction, distraction in social situations, names and words and orientation.
|
1 year post-infection
|
Dietary intake by a food diary
Time Frame: 1 year post-infection
|
A 3-day food diary will be used to investigate the dietary intake.
|
1 year post-infection
|
Smell by the Sniffing Sticks treshold test
Time Frame: 1 year post-infection
|
The average of the last four reversal points is used as final threshold score.
|
1 year post-infection
|
Taste using the taste strips 'filter paper disc method' test
Time Frame: 1 year post-infection
|
A maximum score of 16 correct taste detections can be retrieved indication good taste function.
|
1 year post-infection
|
Taste and smell function using the taste and smell function questionnaire
Time Frame: 1 year post-infection
|
The questionnaire will retrieve a maximal score of 0-52 and 0-44 for taste and smell, respectively, in which higher scores indicate problems with taste and smell function.
|
1 year post-infection
|
The hospital anxiety and depression scale (HADS) to determine anxiety and depression levels
Time Frame: 1 year post-infection
|
The HADS will retrieve a total score of 0-21 in which lower levels indicate higher levels of anxiety or depression.
|
1 year post-infection
|
The Perceived stress scale (PSS) to determine stress levels
Time Frame: 1 year post-infection
|
The PSS will retrieve a total score of 0-40 in which lower scores indicate higher stress levels.
|
1 year post-infection
|
Perceived social support using the multidimensional scale of perceived social support (MSPSS)
Time Frame: 1 year post-infection
|
A total score of 12-84 can be retrieved in which lower scores indicate lower levels of social support.
|
1 year post-infection
|
Loneliness using the loneliness scale (LS)
Time Frame: 1 year post-infection
|
The LS will retrieve a total score of 0-11 in which higher scores indicate strong loneliness.
|
1 year post-infection
|
Subjective multidimensional health status by euroqol-5 dimensions
Time Frame: 1 year post-infection
|
The EQ-5D consists of 5 domains (mobility, self-care, usual activity, pain/discomfort, anxiety/depression) and a visual analogue scale.
|
1 year post-infection
|
Dyspnea using the modified medical research council (mMRC)
Time Frame: 1 year post-infection
|
The mMRC will retrieve a total score of 0-5 in which higher levels indicate more dyspnea.
|
1 year post-infection
|
Fatigue using the Checklist Individual Strength (CIS)
Time Frame: 1 year post-infection
|
The CIS will retrieve a total score of 20-140 in which higher scores indicate more fatigue.
|
1 year post-infection
|
Sleep quality using the Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 1 year post-infection
|
The total PSQI score will vary between 0-21 in which higher scores indicate poor sleep quality.
|
1 year post-infection
|
General pain using the Visual Analogue Scale (VAS)
Time Frame: 1 year post-infection
|
A total score of 0-100 will be retrieved in which higher scores indicate more pain.
|
1 year post-infection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medical history
Time Frame: 1 year post-infection
|
Retrieved from medical records and self-report
|
1 year post-infection
|
Treatments/therapies after SARS-CoV-2 infection
Time Frame: 1 year post-infection
|
Retrieved from medical records and self-report
|
1 year post-infection
|
Vaccination for COVID-19
Time Frame: 1 year post-infection
|
Retrieved from medical records and self-report
|
1 year post-infection
|
Re-infection with COVID-19
Time Frame: 1 year post-infection
|
Retrieved from medical records and self-report
|
1 year post-infection
|
Medication use
Time Frame: 1 year post-infection
|
Retrieved from medical records and self-report
|
1 year post-infection
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Smoking status
Time Frame: 1 year post-infection
|
Based on self-report
|
1 year post-infection
|
Sociodemographics
Time Frame: 1 year post-infection
|
Including age, gender, race, living situation, household composition, marital status, educational level, smoking status, alcohol consumed, employment status, occupation, volunteer work, and income level.
|
1 year post-infection
|
Motivation by the Behavioral Regulation in Exercise Questionnaire (BREQ-2)
Time Frame: 1 year post-infection
|
The BREQ-2 will provide several motivation types based on the self-determination theory.
|
1 year post-infection
|
Motivation by the Regulation of Eating Behaviors Questionnaire (REBS)
Time Frame: 1 year post-infection
|
The REBS will provide several motivation types based on the self-determination theory.
|
1 year post-infection
|
Date of SARS-CoV-2 infection
Time Frame: 1 year post-infection
|
The date of the SARS-CoV-2 infection will be extracted from the medical records in order to determine the time since the COVID-19 infection.
|
1 year post-infection
|
Collaborators and Investigators
Investigators
- Study Director: Annemie Schols, PhD, Maastricht University Medical Centre
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL76949.068.21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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