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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04794985
• Other study ID #: NL76949.068.21
• Status: Recruiting
• Start date: February 17, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: October 2023
• Source: Maastricht University Medical Center
• Contact: Rosanne Beijers, PhD
• Phone: +31433882990
• Email: r.beijers[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Locations

Country	Name	City	State
Netherlands	Zuyderland Medical Center	Heerlen
Netherlands	Maastricht University Medical Center	Maastricht
Netherlands	VieCuri Medical Center	Venlo

Sponsors (3)

Lead Sponsor	Collaborator
Maastricht University Medical Center	VieCuri Medical Centre, Zuyderland Medical Centre

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Smoking status	Based on self-report	1 year post-infection
Other	Sociodemographics	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
Other	Motivation by the Behavioral Regulation in Exercise Questionnaire (BREQ-2)	The BREQ-2 will provide several motivation types based on the self-determination theory.	1 year post-infection
Other	Motivation by the Regulation of Eating Behaviors Questionnaire (REBS)	The REBS will provide several motivation types based on the self-determination theory.	1 year post-infection
Other	Date of SARS-CoV-2 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
Primary	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
Primary	Diffusion capacity measured with the single breath method	To determine diffusion capacity for carbon monoxide	1 year post-infection
Primary	(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
Primary	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
Primary	Lean mass by dual-energy X-ray (DEXA)-scan	Total lean mass will be determined using a DEXA-scan.	1 year post-infection
Primary	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
Primary	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
Primary	Vertebral fracture assessment by dual-energy X-ray (DEXA-scan)	Vertebral fracture assessment will be determined using a DEXA-scan.	1 year post-infection
Primary	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
Primary	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
Primary	Weight will be measured on a weighing scale	Weight will be measured on a weighing scale.	1 year post-infection
Primary	Height will be measured using a stadiometer	Height will be measured using a stadiometer.	1 year post-infection
Primary	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
Primary	Fasted resting energy expenditure by indirect calorimetry (ventilated hood)	VO2 and VCO2 will be measured to determine energy expenditure.	1 year post-infection
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Six minute walking test to determine exercise capacity	Six minute walking distance will be determined.	1 year post-infection
Primary	Peak work rate by cardiopulmonary cycling exercise test (CPET)	Maximal work rate (W) will be determined during the CPET	1 year post-infection
Primary	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
Primary	Maximal heart rate during cardiopulmonary cycling exercise test (CPET)	Maximal heart will be measured during the CPET.	1 year post-infection
Primary	Respiratory muscle strength by mouth pressure	Inspiratory and expiratory mouth pressure will be measured.	1 year post-infection
Primary	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
Primary	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
Primary	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
Primary	Physical activity level by accelerometry	An accelerometer will be worn for 7 days to determine physical activity level.	1 year post-infection
Primary	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
Primary	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
Primary	Dietary intake by a food diary	A 3-day food diary will be used to investigate the dietary intake.	1 year post-infection
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Medical history	Retrieved from medical records and self-report	1 year post-infection
Secondary	Treatments/therapies after SARS-CoV-2 infection	Retrieved from medical records and self-report	1 year post-infection
Secondary	Vaccination for COVID-19	Retrieved from medical records and self-report	1 year post-infection
Secondary	Re-infection with COVID-19	Retrieved from medical records and self-report	1 year post-infection
Secondary	Medication use	Retrieved from medical records and self-report	1 year post-infection