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

Study Description

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.

Condition or disease
Post-COVID Condition

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

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 5 Years
• Official Title: Munich Long COVID Registry for Children, Adolescents, and Adults (MLC-R)
• Actual Study Start Date: July 20, 2022
• Estimated Primary Completion Date: July 20, 2027
• Estimated Study Completion Date: July 20, 2027

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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.
2. Phenotyping of Post-COVID condition: Physical Examination [ Time Frame: 5 years ]
   Routine physical examination to achieve a profound and detailed Post-COVID condition phenotype.
3. 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.
4. 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.

Secondary Outcome Measures :

1. Analyzation of numbers of physicians involved [ Time Frame: 5 years ]
   Patients' journeys will be analyzed in terms of the number of physicians involved
2. 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
3. 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
4. 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.
5. 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).
6. Prevalence of Comorbidities [ Time Frame: 5 years ]
   Prevalence of comorbidities of patients with Post-COVID condition will be analyzed.
7. 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).

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients with PCC

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

Contacts and Locations

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

Locations

Germany

MRI Chronic Fatigue Center for Young People (MCFC) Children's Hospital, Technical University of Munich & Munich Municipal Hospital; Recruiting

Munich, Bavaria, Germany, 80804

Contact: Uta Behrends, Prof. Dr. med. +89 3068 2632 register.mcfc@mri.tum.de

Sponsors and Collaborators

Technical University of Munich

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

More Information

• Responsible Party: Technical University of Munich
• ClinicalTrials.gov Identifier: NCT05638724
• Other Study ID Numbers: MLC-R Study
• First Posted: December 6, 2022
• Last Update Posted: February 15, 2024
• Last Verified: December 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

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

Keywords provided by Technical University of Munich:

Long COVID; Post-COVID; ME/CFS; CFS/ME; SARS-CoV-2; COVID-19

Additional relevant MeSH terms:

Post-Acute COVID-19 Syndrome; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes