The overall aim of this study is to assess the multidimensional health status of COVID-19 survivors one year post-infection using validated subjective and objective measures.
ID
Source
Brief title
Condition
- Viral infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Subjective multidimensional health status (EQ-5D)
Secondary outcome
Multidimensional health outcomes:
- Physiological and metabolic health
• Lung function by pre- and post-bronchodilator spirometry;
• Diffusion capacity using the single breath method;
• Persistent lung damage (CT-scan);
• Body composition by dual-energy X-ray (DEXA)-scan en CT-scan;
• Fasted resting energy expenditure by indirect calorimetry (ventilated hood);
• Cardiometabolic health by determination of the parameters of the metabolic
syndrome:
o Resting blood pressure
o Waist circumference
o Fasted glucose level (blood)
o Fasted high-density, low-density and total lipoprotein levels (HDL and LDL)
(blood)
o Fasted triglycerides (blood)
• Inflammatory status (blood)
- Physical capability
• Exercise capacity by the six-minute walking test and a cardiopulmonary
cycling exercise test;
• Respiratory muscle strength by inspiratory and expiratory mouth pressure;
• Upper extremity muscle strength by measuring handgrip strength;
• Lower extremity muscle strength by measuring isometric muscle strength using
the Biodex;
• Mobility using the short physical performance battery and all individual
items;
• Physical activity level by accelerometry.
- Cognitieve functie:
• Montreal Cognitive Assessment (MOCA);
• Cognitive failure questionnaire (CFQ);
- Neurosensory function
• Dietary intake by a food diary
• Smell and taste using the Taste Strips *filter paper disc method* and the
Sniffin Sticks threshold test, respectively as well as the taste and smell
function questionnaire;
- Psychosocial well-being
• Anxiety, depression and stress using:
o The hospital anxiety and depression scale (HADS)
o Perceived stress scale (PSS)
- Social well-being
• Social support using the multidimensional scale of perceived social support
(MSPSS) and the loneliness scale (LS).
- Patient reported outcomes
• Dyspnea using the modified medical research council (mMRC)
• Fatigue using the Checklist Individual Strength (CIS)
• Sleep quality using the Pittsburgh Sleep Quality Index (PSQI)
• General pain using the Visual Analogue Scale (VAS)
- Medical history (including treatment during SARS-CoV-2 infection);
- Treatments/therapies after SARS-CoV-2 infection
- Vaccination for COVID-19;
- Re-infection with COVID-19;
- Medication use;
Subgroup analysis related to METC 2020-2230
Only in case a chest-CT scan has been obtained during screening for SARS-CoV-2
or during regular care follow-up visits and only in case this CT-scan meets the
requirements for reliable extrapulmonary quantifications of muscle and adipose
tissue cross sectional area, the chest-CT scan obtained in the current study
will be compared to previous CT-scans in order to assess pulmonary and
extrapulmonary changes. In this case, the chest CT-scans obtained for COVID-19
reasons will be extracted from medical records and analyzed according to the
same protocol as the current study, unless this has already been done in METC
2020-2230.
Background summary
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.
Study objective
The overall aim of this study is to assess the multidimensional health status
of COVID-19 survivors one year post-infection using validated subjective and
objective measures.
Study design
This study will be a single center prospective observational study
investigating 200 COVID-19 survivors.
Study burden and risks
Risks and inconveniences associated with this study are minimal and are limited
to the time investment of performing the measurements and to possible
confronting questions in several questionnaires. Blood drawing is the only
invasive procedure to be undertaken during the measurement days, and given the
routine status of this procedure, also within our own research group, we expect
this procedure to pose no risks to participants. We will measure lung function
by spirometry before and after inhalation of salbutamol (bronchodilator). This
is a standard procedure to measure the reversibility of the lung function. The
inhalation of salbutamol may sometimes be associated with dizziness and
palpitations. However, this will resolve shortly after inhalation. There is no
risk associated with the DEXA-scan. The radiation dose emitted during a
DEXA-scan is 0.001 mSv. This is very low exposure compared to the total
background radiation in the Netherlands, which is ±2.5 mSv/year. In addition,
we will obtain a chest CT-scan. This chest-CT-scan exposes the subjects to
extra radiation (±2-3 mSv), which is still in the range of the yearly total
background radiation in the Netherlands. Although this radiation is low, it may
put subjects at a slightly increased risk for developing cancer. Moreover,
incidental findings might be seen on these scans, such as pulmonary nodules,
that need further diagnostic work-up outside the frame of this research. Such
findings may result in additional diagnostic procedures and may lead to
unwarranted subject discomfort during such a diagnostic trajectory. Based on
these risks, obtaining a chest-CT-scan is voluntary for the subjects. In case
subjects do not want a chest CT-scan, they can still participate in the study.
In total, subjects have to come one full day or two half days for measurements
to the MUMC, depending on the preferences of the subjects.
P Debyelaan 25
Maastricht 6202 AZ
NL
P Debyelaan 25
Maastricht 6202 AZ
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04794985 |
| CCMO | NL76949.068.21 |