Post-COVID ConditionMLC-RNCT05638724
Munich Long COVID Registry for Children, Adolescents, and Adults
An observational study of Post-COVID Condition, run by Technical University of Munich at 1 site in Germany.
Trial summary
The MLC-R aims to create a large-scale registry that provides data on epidemiology, phenotypes, and disease trajectories of and health care for Long COVID at any age in Germany, which can be used for future clinical trials. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post-COVID Condition
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 20 Jul 2022to 20 Jul 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with PCC
Who may be able to join
- Written informed consent of the patient or legal guardian.
- Confirmed SARS-CoV-2 vaccination and/or confirmed or probable SARS-CoV-2 infection: Positive SARS-CoV-2 polymerase chain reaction (PCR) or rapid antigen test (AST), documented probable COVID-19 (e.g., typical CT scan), probable COVID-19 with a history of high-risk contact, anti-SARS-CoV-2-N antibodies (and/or in non-vaccinated people -S-IgG antibodies) following probable COVID-19.
- Additional ICD-10 codes: U09.9!V: Suspected post-COVID-19 condition, unspecified; U12.9!V: suspected adverse reactions to COVID-19 vaccine use, unspecified (post-COVIDvac condition).
Who cannot join
- Any subsequent medical data that question the diagnosis of PCC or post-COVIDvac condition
- Clinical picture can be explained by another underlying disease.
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
MRI Chronic Fatigue Center for Young People (MCFC) Children's Hospital, Technical University of Munich & Munich Municipal Hospital
Munich, Bavaria, 80804
Uta Behrends, Prof. Dr. med., +89 3068 2632, register.mcfc@mri.tum.de
About this study
Official title: Munich Long COVID Registry for Children, Adolescents, and Adults (MLC-R)
The MLC-R aims to create a large-scale registry that provides data on epidemiology, phenotypes, and disease trajectories of and health care for Long COVID at any age in Germany, which can be used for future clinical trials.
Read the detailed description
Infections with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been observed in Germany since January 2020 and can result in acute coronavirus disease 2019 (COVID-19) as well as in long-term sequela, referred to as Long COVID. The umbrella term Long COVID comprises ongoing new SARS-CoV-2-associated symptoms later than four weeks from the onset of acute COVID-19. The term Post-COVID-Condition (PCC) was introduced by the WHO and stands for ongoing or new SARS-CoV-2-associated symptoms, which persisted for at least two months. These symptoms often include fatigue, brain fog, dyspnea, orthostatic intolerance, as well as exercise intolerance, with a worsening of symptoms after mild daily activities (post-exertional malaise, PEM). PCC can severely impair daily function, social participation, and health-related quality of life. The prevalence was estimated as up to 15% in infected people with pre-Omicron variants and lower with Omicron variants. Risk factors include female gender and pre-existing morbidity, with low risk in young children. The most severe form of PCC in people with initially mild or moderate COVID-19 is myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The prevalence of ME/CFS was shown to increase in the context of the pandemic. While progress has been made in deciphering the pathogenesis of acute COVID-19, the mechanisms of Long COVID/PCC are poorly understood. Increasing evidence indicates that remaining viral particles, as well as inflammation, altered microcirculation, dysfunction of the autonomic nervous system, and/or autoimmunity, may contribute.
With the web-based German MLC-R, we aim at deep phenotyping of PCC, identification of subtypes and risk factors, describing trajectories of the disease and patient journeys, and providing clinical data for future clinical trials. Patients are also invited to contribute biosamples for future translational research.
- Conditions
- Post-COVID Condition
- Keywords
- Long COVID, Post-COVID, ME/CFS, CFS/ME, SARS-CoV-2, COVID-19
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Fatigue Syndrome, Chronic, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenotyping of Post-COVID condition: Medical History
Routine assessment of the medical history, such as current and previous medication, vaccinations, comorbidities, and more, to achieve a profound and detailed Post-COVID condition phenotype.
Measured: 5 years
Phenotyping of Post-COVID condition: Physical Examination
Routine physical examination to achieve a profound and detailed Post-COVID condition phenotype.
Measured: 5 years
Phenotyping of Post-COVID condition: Laboratory Parameters
Measurement of a routine set of laboratory parameters including blood tests (cell count, C-reactive protein, organ function, immunoglobulins, antibodies, etc.) and urine/stool analysis (calprotectin, blood) to achieve a profound Post-COVID condition phenotype.
Measured: 5 years
Phenotyping of Post-COVID condition: Functional Tests
Technical exams (e.g. pulmonary function tests, electrocardiography, ultrasound, magnetic resonance imaging, etc.) will be performed as indicated to achieve a profound and detailed Post-COVID condition phenotype.
Measured: 5 years
Secondary outcomes (7)
Analyzation of numbers of physicians involved
Patients' journeys will be analyzed in terms of the number of physicians involved
Measured: 5 years
Evaluation of kind of spezializations of physicians involved
Patients' journeys will be analyzed in terms of the kind of specializations of physicians involved
Measured: 5 years
Evaluation of kind of the latency of symptoms
Patients' journeys will be analyzed in terms of the kind of specializations of physicians involved
Measured: 5 years
Evaluation of kind of the onset of therapy
Patients' journeys will be analyzed in terms of the latency from symptom onset to initiation of therapy in months.
Measured: 5 years
Definition of Sub-cohorts
Sub-cohorts are identified using routine data. By means of e.g. trigger, disease severity (e.g. Bell score from the worst outcome with 0 points till the best outcome with 100 points), daily functioning (e.g. SF-36).
Measured: 5 years
Prevalence of Comorbidities
Prevalence of comorbidities of patients with Post-COVID condition will be analyzed.
Measured: 5 years
Identification of Candidate Prognostic Markers
Correlation of routine clinical data (e.g., medical history, routine laboratory, and physical examination) with clinical outcome (e.g., health-related quality of life, disease severity, and social participation).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start20 Jul 2022
- Primary completion20 Jul 2027 (estimated)
- Study completion20 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-COVID ConditionStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Ruhr University of Bochum, Technische Universität Dresden, University of Freiburg, University of Hamburg-Eppendorf, Leipniz University Hannover, Germany., Saarland University Homburg,Germany., University of Jena, University of Kassel, Germany., University of Cologne
- Responsible party
- Sponsor
- Investigators
- Uta Behrends, Prof. Dr. med., Principal investigator, MRI Chronic Fatigue Center for Young People (MCFC), Children's Hospital, Technical University of Munich & Munich Municipal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638724
- Sponsor's protocol ID
- MLC-R Study
- Acronym
- MLC-R
- Status last verified
- Dec 2023
- First submitted
- 3 Nov 2022
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Donath Q, Haegele M, Schindler D, Welzhofer T, Christa C, Grabbe A, Leone A, Ilhan C, Weidmann C, Eberhartinger M, Bechtold S, Bursch N, Wolf H, Hieber H, Peo LC, Bucka LA, Stojanov S, Warlitz C, Alberer M, Gerrer K, Hausruckinger A, Mittelstrass K, Wendtner CM, Hoechstetter MA, Grubl A, Toepfner N, Pricoco R, Scheibenbogen C, Mihatsch LL, Behrends U. Risk factors for severe post-COVID condition in children, adolescents, and young adults. Eur J Pediatr. 2026 May 4;185(5):344. doi: 10.1007/s00431-026-06995-3.
PubMed 42082813
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Munich Long COVID Registry for Children, Adolescents, and Adults (MLC-R)
- ClinicalTrials.gov ID
- NCT05638724
- Acronym / sponsor ID
- MLC-R / MLC-R Study
- Conditions
- Post-COVID Condition
- Keywords
- Long COVID, Post-COVID, ME/CFS, CFS/ME, SARS-CoV-2, COVID-19
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Ruhr University of Bochum, Technische Universität Dresden, University of Freiburg, University of Hamburg-Eppendorf, Leipniz University Hannover, Germany., Saarland University Homburg,Germany., University of Jena, University of Kassel, Germany., University of Cologne
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 20 Jul 2027 (estimated)
- Study completion
- 20 Jul 2027 (estimated)
- First posted
- 6 Dec 2022 (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.
The MLC-R aims to create a large-scale registry that provides data on epidemiology, phenotypes, and disease trajectories of and health care for Long COVID at any age in Germany, which can be used for future clinical trials.
Detailed description
Infections with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been observed in Germany since January 2020 and can result in acute coronavirus disease 2019 (COVID-19) as well as in long-term sequela, referred to as Long COVID. The umbrella term Long COVID comprises ongoing new SARS-CoV-2-associated symptoms later than four weeks from the onset of acute COVID-19. The term Post-COVID-Condition (PCC) was introduced by the WHO and stands for ongoing or new SARS-CoV-2-associated symptoms, which persisted for at least two months. These symptoms often include fatigue, brain fog, dyspnea, orthostatic intolerance, as well as exercise intolerance, with a worsening of symptoms after mild daily activities (post-exertional malaise, PEM). PCC can severely impair daily function, social participation, and health-related quality of life. The prevalence was estimated as up to 15% in infected people with pre-Omicron variants and lower with Omicron variants. Risk factors include female gender and pre-existing morbidity, with low risk in young children. The most severe form of PCC in people with initially mild or moderate COVID-19 is myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The prevalence of ME/CFS was shown to increase in the context of the pandemic. While progress has been made in deciphering the pathogenesis of acute COVID-19, the mechanisms of Long COVID/PCC are poorly understood. Increasing evidence indicates that remaining viral particles, as well as inflammation, altered microcirculation, dysfunction of the autonomic nervous system, and/or autoimmunity, may contribute.
With the web-based German MLC-R, we aim at deep phenotyping of PCC, identification of subtypes and risk factors, describing trajectories of the disease and patient journeys, and providing clinical data for future clinical trials. Patients are also invited to contribute biosamples for future translational research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with PCC
Key inclusion criteria (3 listed)
- Written informed consent of the patient or legal guardian.
- Confirmed SARS-CoV-2 vaccination and/or confirmed or probable SARS-CoV-2 infection: Positive SARS-CoV-2 polymerase chain reaction (PCR) or rapid antigen test (AST), documented probable COVID-19 (e.g., typical CT scan), probable COVID-19 with a history of high-risk contact, anti-SARS-CoV-2-N antibodies (and/or in non-vaccinated people -S-IgG antibodies) following probable COVID-19.
- Additional ICD-10 codes: U09.9!V: Suspected post-COVID-19 condition, unspecified; U12.9!V: suspected adverse reactions to COVID-19 vaccine use, unspecified (post-COVIDvac condition).
Key exclusion criteria (3 listed)
- Any subsequent medical data that question the diagnosis of PCC or post-COVIDvac condition
- Clinical picture can be explained by another underlying disease.
- Pregnancy
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
Phenotyping of Post-COVID condition: Medical History
Time frame: 5 years
Routine assessment of the medical history, such as current and previous medication, vaccinations, comorbidities, and more, to achieve a profound and detailed Post-COVID condition phenotype.
Phenotyping of Post-COVID condition: Physical Examination
Time frame: 5 years
Routine physical examination to achieve a profound and detailed Post-COVID condition phenotype.
Phenotyping of Post-COVID condition: Laboratory Parameters
Time frame: 5 years
Measurement of a routine set of laboratory parameters including blood tests (cell count, C-reactive protein, organ function, immunoglobulins, antibodies, etc.) and urine/stool analysis (calprotectin, blood) to achieve a profound Post-COVID condition phenotype.
Phenotyping of Post-COVID condition: Functional Tests
Time frame: 5 years
Technical exams (e.g. pulmonary function tests, electrocardiography, ultrasound, magnetic resonance imaging, etc.) will be performed as indicated to achieve a profound and detailed Post-COVID condition phenotype.
7 secondary outcomes
Analyzation of numbers of physicians involved
Time frame: 5 years
Evaluation of kind of spezializations of physicians involved
Time frame: 5 years
Evaluation of kind of the latency of symptoms
Time frame: 5 years
Evaluation of kind of the onset of therapy
Time frame: 5 years
Definition of Sub-cohorts
Time frame: 5 years
Prevalence of Comorbidities
Time frame: 5 years
Identification of Candidate Prognostic Markers
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Derived from this study: PubMed 42082813Donath Q, Haegele M, Schindler D, Welzhofer T, Christa C, Grabbe A, Leone A, Ilhan C, Weidmann C, Eberhartinger M, Bechtold S, Bursch N, Wolf H, Hieber H, Peo LC, Bucka LA, Stojanov S, Warlitz C, Alberer M, Gerrer K, Hausruckinger A, Mittelstrass K, Wendtner CM, Hoechstetter MA, Grubl A, Toepfner N, Pricoco R, Scheibenbogen C, Mihatsch LL, Behrends U. Risk factors for severe post-COVID condition in children, adolescents, and young adults. Eur J Pediatr. 2026 May 4;185(5):344. doi: 10.1007/s00431-026-06995-3.
- Individual participant dataSharing planned: Undecided
Related trials for Post-COVID Condition
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
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.
Uta Behrends, Prof. Dr. med. principal investigator
MRI Chronic Fatigue Center for Young People (MCFC), Children's Hospital, Technical University of Munich & Munich Municipal Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-COVID Condition, run by Technical University of Munich at 1 site in Germany.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Uta Behrends, Prof. Dr. med. (+4989 3068 2632, uta.behrends@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenotyping of Post-COVID condition: Medical History (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05638724, which also lists 1 linked publication.
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 15 Feb 2024.