Covid19NCT04794985
Post-COVID-Health Study: Multidimensional Health Status of COVID-19 Survivors One Year After a SARS-CoV-2 Infection
An observational study of Covid19, run by Maastricht University Medical Center at 3 sites in Netherlands.
Trial summary
This study assesses the multidimensional health status of COVID-19 survivors one-year post-infection using validated subjective and objective measures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- How many people
- 140 participants
- Where
- 3 sitesNetherlands
- Study dates
- 17 Feb 2022to 20 Aug 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients not willing to participate;
- Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements.
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Zuyderland Medical Center
Heerlen, 6419
Maastricht University Medical Center
Maastricht, 6229 HX
VieCuri Medical Center
Venlo, 5912 BL
About this study
This study assesses the multidimensional health status of COVID-19 survivors one-year post-infection using validated subjective and objective measures.
Read the 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.
- Conditions
- Covid19
- Keywords
- Multidimensional health, COVID-19, Long-term consequences
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year post-infection
Diffusion capacity measured with the single breath method
To determine diffusion capacity for carbon monoxide
Measured: 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.
Measured: 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.
Measured: 1 year post-infection
Lean mass by dual-energy X-ray (DEXA)-scan
Total lean mass will be determined using a DEXA-scan.
Measured: 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.
Measured: 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.
Measured: 1 year post-infection
Vertebral fracture assessment by dual-energy X-ray (DEXA-scan)
Vertebral fracture assessment will be determined using a DEXA-scan.
Measured: 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.
Measured: 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.
Measured: 1 year post-infection
Weight will be measured on a weighing scale
Weight will be measured on a weighing scale.
Measured: 1 year post-infection
Height will be measured using a stadiometer
Height will be measured using a stadiometer.
Measured: 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)
Measured: 1 year post-infection
Fasted resting energy expenditure by indirect calorimetry (ventilated hood)
VO2 and VCO2 will be measured to determine energy expenditure.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year post-infection
Six minute walking test to determine exercise capacity
Six minute walking distance will be determined.
Measured: 1 year post-infection
Peak work rate by cardiopulmonary cycling exercise test (CPET)
Maximal work rate (W) will be determined during the CPET
Measured: 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.
Measured: 1 year post-infection
Maximal heart rate during cardiopulmonary cycling exercise test (CPET)
Maximal heart will be measured during the CPET.
Measured: 1 year post-infection
Respiratory muscle strength by mouth pressure
Inspiratory and expiratory mouth pressure will be measured.
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.
Measured: 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.
Measured: 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.
Measured: 1 year post-infection
Physical activity level by accelerometry
An accelerometer will be worn for 7 days to determine physical activity level.
Measured: 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.
Measured: 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.
Measured: 1 year post-infection
Dietary intake by a food diary
A 3-day food diary will be used to investigate the dietary intake.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year post-infection
Secondary outcomes (5)
Medical history
Retrieved from medical records and self-report
Measured: 1 year post-infection
Treatments/therapies after SARS-CoV-2 infection
Retrieved from medical records and self-report
Measured: 1 year post-infection
Vaccination for COVID-19
Retrieved from medical records and self-report
Measured: 1 year post-infection
Re-infection with COVID-19
Retrieved from medical records and self-report
Measured: 1 year post-infection
Medication use
Retrieved from medical records and self-report
Measured: 1 year post-infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start17 Feb 2022
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Why it stopped: With included subjects (n=140) we have sufficient power to answer the primary research question.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- VieCuri Medical Centre, Zuyderland Medical Centre
- Responsible party
- Sponsor
- Investigators
- Annemie Schols, PhD, Study director, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794985
- Sponsor's protocol ID
- NL76949.068.21
- Status last verified
- Jan 2025
- First submitted
- 9 Mar 2021
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-COVID-Health Study: Multidimensional Health Status of COVID-19 Survivors One Year After a SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04794985
- Acronym / sponsor ID
- NL76949.068.21
- Conditions
- Covid19
- Keywords
- Multidimensional health, COVID-19, Long-term consequences
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: With included subjects (n=140) we have sufficient power to answer the primary research question.
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- VieCuri Medical Centre, Zuyderland Medical Centre
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- COVID-19 positive based on:
- Age of ≥18 years;
- Able to provide informed consent;
- Understanding of Dutch language.
Key exclusion criteria (2 listed)
- Patients not willing to participate;
- Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lung function measured with spirometry
Time frame: 1 year post-infection
Pre- and post-bronchodilator spirometry will be performed to determine forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1).
Diffusion capacity measured with the single breath method
Time frame: 1 year post-infection
To determine diffusion capacity for carbon monoxide
(Persistent) lung damage
Time frame: 1 year post-infection
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.
Bone mineral density by dual-energy X-ray (DEXA)-scan
Time frame: 1 year post-infection
Total bone mineral density (BMD) as well as BMD of the lumbar spine and total hip-neck will be determined using a DEXA-scan.
Lean mass by dual-energy X-ray (DEXA)-scan
Time frame: 1 year post-infection
Total lean mass will be determined using a DEXA-scan.
Fat free mass by dual-energy X-ray (DEXA)-scan
Time frame: 1 year post-infection
Total fat free mass will be measured using a DEXA-scan.
Fat mass by dual-energy X-ray (DEXA)-scan
Time frame: 1 year post-infection
Total fat mass and fat percentage as well as visceral fat mass will be measured using a DEXA-scan.
Vertebral fracture assessment by dual-energy X-ray (DEXA-scan)
Time frame: 1 year post-infection
Vertebral fracture assessment will be determined using a DEXA-scan.
Muscle cross sectional area on chest CT-scan
Time frame: 1 year post-infection
Muscle cross sectional area will be determined based on pre-established Hounsfield Units on the chest CT-scan.
Adipose tissue cross sectional area on chest CT-scan
Time frame: 1 year post-infection
Muscle cross sectional area will be determined based on pre-established Hounsfield Units on the chest CT-scan.
Weight will be measured on a weighing scale
Time frame: 1 year post-infection
Weight will be measured on a weighing scale.
Height will be measured using a stadiometer
Time frame: 1 year post-infection
Height will be measured using a stadiometer.
Body mass index (BMI) will be calculated from the weight and height
Time frame: 1 year post-infection
Weight and height will be combined to report BMI in (kg/m^2)
Fasted resting energy expenditure by indirect calorimetry (ventilated hood)
Time frame: 1 year post-infection
VO2 and VCO2 will be measured to determine energy expenditure.
Resting blood pressure
Time frame: 1 year post-infection
Resting diastolic and systolic blood pressure will be measured as part of the cardiometabolic profile to determine the prevalence of the metabolic syndrome.
Waist circumference
Time frame: 1 year post-infection
Waist circumference will be measured as part of the cardiometabolic profile to determine the prevalence of the metabolic syndrome.
Fasting glucose levels
Time frame: 1 year post-infection
Fasting glucose levels will be determined in sampled blood as part of the cardiometabolic profile to determine the prevalence of the metabolic syndrome.
Fasted lipid profile
Time frame: 1 year post-infection
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.
Six minute walking test to determine exercise capacity
Time frame: 1 year post-infection
Six minute walking distance will be determined.
Peak work rate by cardiopulmonary cycling exercise test (CPET)
Time frame: 1 year post-infection
Maximal work rate (W) will be determined during the CPET
Peak O2-consumption and CO2-production by cardiopulmonary cycling exercise test (CPET)
Time frame: 1 year post-infection
Maximal O2 consumption and CO2 production will be determined during the CPET.
Maximal heart rate during cardiopulmonary cycling exercise test (CPET)
Time frame: 1 year post-infection
Maximal heart will be measured during the CPET.
Respiratory muscle strength by mouth pressure
Time frame: 1 year post-infection
Inspiratory and expiratory mouth pressure will be measured.
Upper extremity muscle strength by measuring handgrip strength
Time frame: 1 year post-infection
A hydraulic grip strength dynamometer will be used to measure the maximal handgrip strength.
Lower extremity muscle strength by measuring isometric muscle strength
Time frame: 1 year post-infection
Maximal isometric upper leg muscle strength will be measured of the quadriceps muscle using a Biodex dynamometer.
Mobility using the short physical performance battery (SPPB)
Time frame: 1 year post-infection
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.
Physical activity level by accelerometry
Time frame: 1 year post-infection
An accelerometer will be worn for 7 days to determine physical activity level.
Cognitive function by Montreal Cognitive Assessment (MOCA)
Time frame: 1 year post-infection
The MOCA will lead to a total score of 0-30, in which lower scores indicate less cognitive function.
Cognitive function using the cognitive failure questionnaire (CFQ)
Time frame: 1 year post-infection
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.
Dietary intake by a food diary
Time frame: 1 year post-infection
A 3-day food diary will be used to investigate the dietary intake.
Smell by the Sniffing Sticks treshold test
Time frame: 1 year post-infection
The average of the last four reversal points is used as final threshold score.
Taste using the taste strips 'filter paper disc method' test
Time frame: 1 year post-infection
A maximum score of 16 correct taste detections can be retrieved indication good taste function.
Taste and smell function using the taste and smell function questionnaire
Time frame: 1 year post-infection
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.
The hospital anxiety and depression scale (HADS) to determine anxiety and depression levels
Time frame: 1 year post-infection
The HADS will retrieve a total score of 0-21 in which lower levels indicate higher levels of anxiety or depression.
The Perceived stress scale (PSS) to determine stress levels
Time frame: 1 year post-infection
The PSS will retrieve a total score of 0-40 in which lower scores indicate higher stress levels.
Perceived social support using the multidimensional scale of perceived social support (MSPSS)
Time frame: 1 year post-infection
A total score of 12-84 can be retrieved in which lower scores indicate lower levels of social support.
Loneliness using the loneliness scale (LS)
Time frame: 1 year post-infection
The LS will retrieve a total score of 0-11 in which higher scores indicate strong loneliness.
Subjective multidimensional health status by euroqol-5 dimensions
Time frame: 1 year post-infection
The EQ-5D consists of 5 domains (mobility, self-care, usual activity, pain/discomfort, anxiety/depression) and a visual analogue scale.
Dyspnea using the modified medical research council (mMRC)
Time frame: 1 year post-infection
The mMRC will retrieve a total score of 0-5 in which higher levels indicate more dyspnea.
Fatigue using the Checklist Individual Strength (CIS)
Time frame: 1 year post-infection
The CIS will retrieve a total score of 20-140 in which higher scores indicate more fatigue.
Sleep quality using the Pittsburgh Sleep Quality Index (PSQI)
Time frame: 1 year post-infection
The total PSQI score will vary between 0-21 in which higher scores indicate poor sleep quality.
General pain using the Visual Analogue Scale (VAS)
Time frame: 1 year post-infection
A total score of 0-100 will be retrieved in which higher scores indicate more pain.
5 secondary outcomes
Medical history
Time frame: 1 year post-infection
Treatments/therapies after SARS-CoV-2 infection
Time frame: 1 year post-infection
Vaccination for COVID-19
Time frame: 1 year post-infection
Re-infection with COVID-19
Time frame: 1 year post-infection
Medication use
Time frame: 1 year post-infection
Results and safety
The study was stopped early (reason given: With included subjects (n=140) we have sufficient power to answer the primary research question.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annemie Schols, PhD study director
Maastricht University Medical Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Maastricht University Medical Center at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: With included subjects (n=140) we have sufficient power to answer the primary research question.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung function measured with spirometry (time frame: 1 year post-infection). The study lists 42 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.