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

NCT04794985 | Terminated

• 1 other identifier: NL76949.068.21
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Covid19

Keywords

Multidimensional health; COVID-19; Long-term consequences

Outcome Measures

Primary Outcomes (42)

• 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 Outcomes (5)

• Medical history

  1 year post-infection

• Treatments/therapies after SARS-CoV-2 infection

  1 year post-infection

• Vaccination for COVID-19

  1 year post-infection

• Re-infection with COVID-19

  1 year post-infection

• Medication use

  1 year post-infection

Other Outcomes (5)

• Smoking status

  1 year post-infection

• Sociodemographics

  1 year post-infection

• Motivation by the Behavioral Regulation in Exercise Questionnaire (BREQ-2)

  1 year post-infection

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Patients not willing to participate;
• Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• VieCuri Medical Centre: collaborator
• Zuyderland Medical Centre: collaborator

Study Sites (3)

Zuyderland Medical Center

Heerlen, 6419, Netherlands

Location

Maastricht University Medical Center

Maastricht, 6229 HX, Netherlands

Location

VieCuri Medical Center

Venlo, 5912 BL, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be obtained.

MeSH Terms

Conditions

COVID-19

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

Study Officials

• Annemie Schols, PhD

  Maastricht University Medical Centre

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 12, 2021
• Study Start: February 17, 2022
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: January 16, 2025

Record last verified: 2025-01

Locations

NL (3)