Clinical trial NCT04794985: Post-COVID-Health Study: Multidimensional Health Status of COVID-19 Survivors One Year After a SARS-CoV-2 Infection
Official title: Post-COVID-Health Study: Multidimensional Health Status of COVID-19 Survivors One Year After a SARS-CoV-2 Infection
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Covid19
Keywords: Multidimensional health
COVID-19
Long-term consequences
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: VieCuri Medical Centre
name: Zuyderland Medical Centre
First posted: 2021-03-12
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All COVID-19 survivors of the MUMC+, VieCuri Medical Center or Zuyderland Medical Center can be included in this study. Both hospitalized (ICU and non-ICU admitted) as well as non-hospitalized patients will be eligible for participation.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lung function measured with spirometry
timeFrame: 1 year post-infection
measure: Diffusion capacity measured with the single breath method
timeFrame: 1 year post-infection
measure: (Persistent) lung damage
timeFrame: 1 year post-infection
measure: Bone mineral density by dual-energy X-ray (DEXA)-scan
timeFrame: 1 year post-infection
measure: Lean mass by dual-energy X-ray (DEXA)-scan
timeFrame: 1 year post-infection
measure: Fat free mass by dual-energy X-ray (DEXA)-scan
timeFrame: 1 year post-infection
measure: Fat mass by dual-energy X-ray (DEXA)-scan
timeFrame: 1 year post-infection
measure: Vertebral fracture assessment by dual-energy X-ray (DEXA-scan)
timeFrame: 1 year post-infection
measure: Muscle cross sectional area on chest CT-scan
timeFrame: 1 year post-infection
measure: Adipose tissue cross sectional area on chest CT-scan
timeFrame: 1 year post-infection
measure: Weight will be measured on a weighing scale
timeFrame: 1 year post-infection
measure: Height will be measured using a stadiometer
timeFrame: 1 year post-infection
measure: Body mass index (BMI) will be calculated from the weight and height
timeFrame: 1 year post-infection
measure: Fasted resting energy expenditure by indirect calorimetry (ventilated hood)
timeFrame: 1 year post-infection
measure: Resting blood pressure
timeFrame: 1 year post-infection
measure: Waist circumference
timeFrame: 1 year post-infection
measure: Fasting glucose levels
timeFrame: 1 year post-infection
measure: Fasted lipid profile
timeFrame: 1 year post-infection
measure: Six minute walking test to determine exercise capacity
timeFrame: 1 year post-infection
measure: Peak work rate by cardiopulmonary cycling exercise test (CPET)
timeFrame: 1 year post-infection
measure: Peak O2-consumption and CO2-production by cardiopulmonary cycling exercise test (CPET)
timeFrame: 1 year post-infection
measure: Maximal heart rate during cardiopulmonary cycling exercise test (CPET)
timeFrame: 1 year post-infection
measure: Respiratory muscle strength by mouth pressure
timeFrame: 1 year post-infection
measure: Upper extremity muscle strength by measuring handgrip strength
timeFrame: 1 year post-infection
measure: Lower extremity muscle strength by measuring isometric muscle strength
timeFrame: 1 year post-infection
measure: Mobility using the short physical performance battery (SPPB)
timeFrame: 1 year post-infection
measure: Physical activity level by accelerometry
timeFrame: 1 year post-infection
measure: Cognitive function by Montreal Cognitive Assessment (MOCA)
timeFrame: 1 year post-infection
measure: Cognitive function using the cognitive failure questionnaire (CFQ)
timeFrame: 1 year post-infection
measure: Dietary intake by a food diary
timeFrame: 1 year post-infection
measure: Smell by the Sniffing Sticks treshold test
timeFrame: 1 year post-infection
measure: Taste using the taste strips 'filter paper disc method' test
timeFrame: 1 year post-infection
measure: Taste and smell function using the taste and smell function questionnaire
timeFrame: 1 year post-infection
measure: The hospital anxiety and depression scale (HADS) to determine anxiety and depression levels
timeFrame: 1 year post-infection
measure: The Perceived stress scale (PSS) to determine stress levels
timeFrame: 1 year post-infection
measure: Perceived social support using the multidimensional scale of perceived social support (MSPSS)
timeFrame: 1 year post-infection
measure: Loneliness using the loneliness scale (LS)
timeFrame: 1 year post-infection
measure: Subjective multidimensional health status by euroqol-5 dimensions
timeFrame: 1 year post-infection
measure: Dyspnea using the modified medical research council (mMRC)
timeFrame: 1 year post-infection
measure: Fatigue using the Checklist Individual Strength (CIS)
timeFrame: 1 year post-infection
measure: Sleep quality using the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 1 year post-infection
measure: General pain using the Visual Analogue Scale (VAS)
timeFrame: 1 year post-infection
Secondary outcomes:
measure: Medical history
timeFrame: 1 year post-infection
measure: Treatments/therapies after SARS-CoV-2 infection
timeFrame: 1 year post-infection
measure: Vaccination for COVID-19
timeFrame: 1 year post-infection
measure: Re-infection with COVID-19
timeFrame: 1 year post-infection
measure: Medication use
timeFrame: 1 year post-infection
Other outcomes:
measure: Smoking status
timeFrame: 1 year post-infection
measure: Sociodemographics
timeFrame: 1 year post-infection
measure: Motivation by the Behavioral Regulation in Exercise Questionnaire (BREQ-2)
timeFrame: 1 year post-infection
measure: Motivation by the Regulation of Eating Behaviors Questionnaire (REBS)
timeFrame: 1 year post-infection
measure: Date of SARS-CoV-2 infection
timeFrame: 1 year post-infection
Locations:
city: Heerlen
country: Netherlands
facility: Zuyderland Medical Center
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Venlo
country: Netherlands
facility: VieCuri Medical Center
Study officials:
affiliation: Maastricht University Medical Centre
name: Annemie Schols, PhD
role: STUDY_DIRECTOR
References: