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

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.

Study Overview

• Status: Recruiting
• Conditions: 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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Uta Behrends, Prof. Dr. med.; Phone Number: +4989 3068 2632; Email: uta.behrends@tum.de
• Study Contact Backup: Name: Daniela Schindler, Dr.; Phone Number: +4989 4140 6995; Email: daniela.schindler@tum.de

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 80804
      • Recruiting
      • MRI Chronic Fatigue Center for Young People (MCFC) Children's Hospital, Technical University of Munich & Munich Municipal Hospital
      • Contact: Uta Behrends, Prof. Dr. med.; Phone Number: +89 3068 2632; Email: register.mcfc@mri.tum.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with PCC

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 years
Phenotyping of Post-COVID condition: Physical Examination	Routine physical examination to achieve a profound and detailed Post-COVID condition phenotype.	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.	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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analyzation of numbers of physicians involved	Patients' journeys will be analyzed in terms of the number of physicians involved	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	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	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.	5 years
Prevalence of Comorbidities	Prevalence of comorbidities of patients with Post-COVID condition will be analyzed.	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).	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).	5 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2022
• Primary Completion (Estimated): July 20, 2027
• Study Completion (Estimated): July 20, 2027

Study Registration Dates

• First Submitted: November 3, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 6, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; Long COVID; Post-COVID; ME/CFS; CFS/ME
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; Post-Infectious Disorders; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: MLC-R Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No