Post-COVID-Health Study: Multidimensional Health Status of COVID-19 Survivors One Year After a SARS-CoV-2 Infection

Study Overview
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Brief Summary
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This study assesses the multidimensional health status of COVID-19 survivors one-year post-infection using validated subjective and objective measures.

Detailed Description
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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.

Official Title
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Post-COVID-Health Study: Multidimensional Health Status of COVID-19 Survivors One Year After a SARS-CoV-2 Infection

Conditions
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Covid19

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function measured with spirometry | 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 | To determine diffusion capacity for carbon monoxide | 1 year post-infection | 
| (Persistent) lung damage | 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 | 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 | Total lean mass will be determined using a DEXA-scan. | 1 year post-infection | 
| Fat free mass by dual-energy X-ray (DEXA)-scan | Total fat free mass will be measured using a DEXA-scan. | 1 year post-infection | 
| Fat mass by dual-energy X-ray (DEXA)-scan | 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) | Vertebral fracture assessment will be determined using a DEXA-scan. | 1 year post-infection | 
| Muscle cross sectional area on chest CT-scan | 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 | 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 | Weight will be measured on a weighing scale. | 1 year post-infection | 
| Height will be measured using a stadiometer | Height will be measured using a stadiometer. | 1 year post-infection | 
| Body mass index (BMI) will be calculated from the weight and height | 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) | VO2 and VCO2 will be measured to determine energy expenditure. | 1 year post-infection | 
| Resting blood pressure | 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 | 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 | 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 | 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 | Six minute walking distance will be determined. | 1 year post-infection | 
| Peak work rate by cardiopulmonary cycling exercise test (CPET) | 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) | 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) | Maximal heart will be measured during the CPET. | 1 year post-infection | 
| Respiratory muscle strength by mouth pressure | Inspiratory and expiratory mouth pressure will be measured. | 1 year post-infection | 
| Upper extremity muscle strength by measuring handgrip strength | 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 | 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) | 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 | An accelerometer will be worn for 7 days to determine physical activity level. | 1 year post-infection | 
| Cognitive function by Montreal Cognitive Assessment (MOCA) | 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) | 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 | A 3-day food diary will be used to investigate the dietary intake. | 1 year post-infection | 
| Smell by the Sniffing Sticks treshold test | 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 | 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 | 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 | 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 | 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) | 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) | 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 | 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) | 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) | 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) | 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) | 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 | Retrieved from medical records and self-report | 1 year post-infection | 
| Treatments/therapies after SARS-CoV-2 infection | Retrieved from medical records and self-report | 1 year post-infection | 
| Vaccination for COVID-19 | Retrieved from medical records and self-report | 1 year post-infection | 
| Re-infection with COVID-19 | Retrieved from medical records and self-report | 1 year post-infection | 
| Medication use | Retrieved from medical records and self-report | 1 year post-infection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multidimensional health, COVID-19, Long-term consequences