Munich Long COVID Registry for Children, Adolescents, and Adults

NCT05638724 | Recruiting

• 1 other identifier: MLC-R Study
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-COVID Condition

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Analyzation of numbers of physicians involved

  5 years

• Evaluation of kind of spezializations of physicians involved

  5 years

• Evaluation of kind of the latency of symptoms

  5 years

• Evaluation of kind of the onset of therapy

  5 years

• Definition of Sub-cohorts

  5 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with PCC

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

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

Munich, Bavaria, 80804, Germany

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Fatigue Syndrome, Chronic; COVID-19

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Uta Behrends, Prof. Dr. med.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uta Behrends, Prof. Dr. med.

CONTACT

+4989 3068 2632; uta.behrends@tum.de

Daniela Schindler, Dr.

CONTACT

+4989 4140 6995; daniela.schindler@tum.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: December 6, 2022
• Study Start: July 20, 2022
• Primary Completion (Estimated): July 20, 2027
• Study Completion (Estimated): July 20, 2027
• Last Updated: February 15, 2024

Record last verified: 2023-12

Locations

DE (1)