Munich Long COVID Registry for Children, Adolescents, and Adults (MLC-R)

• ClinicalTrials.gov Identifier: NCT05638724
• Recruitment Status: Recruiting
• First Posted: December 6, 2022
• Last Update Posted: February 15, 2024
• Sponsor: Technical University of Munich
• Collaborators: Charite University, Berlin, Germany; Ruhr University of Bochum, Germany; Technical University of Dresden, Germany; University of Freiburg; University of Hamburg-Eppendorf; Leipniz University Hannover, Germany.; Saarland University Homburg,Germany.; Friedrich Schiller University Jena, Germany; University of Kassel, Germany.; University of Cologne
• Information provided by (Responsible Party): Technical University of Munich

Tracking Information

• First Submitted Date: November 3, 2022
• First Posted Date: December 6, 2022
• Last Update Posted Date: February 15, 2024
• Actual Study Start Date: July 20, 2022
• Estimated Primary Completion Date: July 20, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 5, 2024)

• 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.

Original Primary Outcome Measures (submitted: December 5, 2022)

Phenotyping Long COVID through a transition-oriented, longitudinal collection of data in a web-based, multicenter registry study. [ Time Frame: 5 years ]

The registry study consists of epidemiologic, medical, and health care data.

Current Secondary Outcome Measures (submitted: February 12, 2024)

• Analyzation of numbers of physicians involved [ Time Frame: 5 years ]
  Patients' journeys will be analyzed in terms of the number of physicians involved
• Evaluation of kind of spezializations of physicians involved [ Time Frame: 5 years ]
  Patients' journeys will be analyzed in terms of the kind of specializations of physicians involved
• Evaluation of kind of the latency of symptoms [ Time Frame: 5 years ]
  Patients' journeys will be analyzed in terms of the kind of specializations of physicians involved
• Evaluation of kind of the onset of therapy [ Time Frame: 5 years ]
  Patients' journeys will be analyzed in terms of the latency from symptom onset to initiation of therapy in months.
• Definition of Sub-cohorts [ Time Frame: 5 years ]
  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).
• Prevalence of Comorbidities [ Time Frame: 5 years ]
  Prevalence of comorbidities of patients with Post-COVID condition will be analyzed.
• Identification of Candidate Prognostic Markers [ Time Frame: 5 years ]
  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).

Original Secondary Outcome Measures (submitted: December 5, 2022)

• Generating data as basis for health care concepts [ Time Frame: 5 years ]
  Generation of epidemiological, medical and health care data as a basis for innovative health care concepts, political measures and public relations work
• Definition of subcohorts [ Time Frame: 5 years ]
  Definition of subcohorts and baseline data for clinical studies
• Comorbidities [ Time Frame: 5 years ]
  Recording the frequency of comorbidities
• Diagnostic parameters [ Time Frame: 5 years ]
  Identification of diagnostic parameters
• Prognosis [ Time Frame: 5 years ]
  Estimation of prognosis
• Treatment approaches [ Time Frame: 5 years ]
  Identification of treatment approaches
• Diagnosis [ Time Frame: 5 years ]
  Harmonization of diagnosis
• Data collection [ Time Frame: 5 years ]
  Harmonization of epidemiological and clinical data collection
• Networking [ Time Frame: 5 years ]
  Networking of dedicated treatment centers
• Training [ Time Frame: 5 years ]
  Perspective improvement of care by training new centers regarding standardized data collection
• Biomaterials [ Time Frame: 5 years ]
  In case of broad consent, residual biomaterials collected during routine care can be stored at the participating centers and used for later study purposes

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Munich Long COVID Registry for Children, Adolescents, and Adults
• Official Title: Munich Long COVID Registry for Children, Adolescents, and Adults (MLC-R)
• Brief 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.

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 Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 5 Years
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients with PCC
• Condition: Post-COVID Condition
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 5, 2022): 1000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 20, 2027
• Estimated Primary Completion Date: July 20, 2027 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

I. Written informed consent of the patient or legal guardian.

II. 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.

III. 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).

Exclusion Criteria:

• Any subsequent medical data that question the diagnosis of PCC or post-COVIDvac condition
• Clinical picture can be explained by another underlying disease.
• Pregnancy

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No

Contacts

Contact: Uta Behrends, Prof. Dr. med.; +4989 3068 2632; uta.behrends@tum.de

Contact: Daniela Schindler, Dr.; +4989 4140 6995; daniela.schindler@tum.de

• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT05638724
• Other Study ID Numbers: MLC-R Study
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Technical University of Munich
• Original Responsible Party: Same as current
• Current Study Sponsor: Technical University of Munich
• Original Study Sponsor: Same as current

Collaborators

• Charite University, Berlin, Germany
• Ruhr University of Bochum, Germany
• Technical University of Dresden, Germany
• University of Freiburg
• University of Hamburg-Eppendorf
• Leipniz University Hannover, Germany.
• Saarland University Homburg,Germany.
• Friedrich Schiller University Jena, Germany
• University of Kassel, Germany.
• University of Cologne

Investigators

• Principal Investigator: Uta Behrends, Prof. Dr. med.; MRI Chronic Fatigue Center for Young People (MCFC), Children's Hospital, Technical University of Munich & Munich Municipal Hospital

• PRS Account: Technical University of Munich
• Verification Date: December 2023