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Recruiting
NCT05638724
Munich Long COVID Registry Study for Children, Adolescents and Adults (MLC-R), COVID-19, SARS-CoV-2
Conditions: Long COVID
Sex: All
Enrollment: 1000
Sponsor: Technical University of Munich
Location: Germany
Summary
Long COVID refers to persistent symptoms after a generally mild acute COVID-19.
Because the symptoms are often complex and vary from person to person, the term post-COVID syndrome is used synonymously.
In the ICD-10 catalog, Long COVID is mapped as U09.9 as "post-COVID-19 conditions."
Long COVID carries a high risk for chronic morbidity.
This has serious consequences for individuals and society, especially when manifesting in young adulthood, adolescence, and childhood.
Current data show that predominantly young women aged 30-40 years are affected by severe Long COVID.
Despite only mild acute COVID-19, 10-15% of patients still show persistent symptoms six months later, including particularly frequently pathological exhaustion (fatigue), exercise intolerance with symptom worsening after exertion (so-called post-exertional malaise), neurocognitive complaints and circulatory disorders.
In addition, general symptoms such as sleep disturbances, pain, or subfebrile temperatures have been described, as well as symptoms of all organ systems.In children and adolescents, less prevalence data are available to date.
In initial studies, 4.4% and 4.6% of children and adolescents, respectively, show persistent symptoms after four weeks, 9.8% of 2-11 year olds and 13% of 12-16 year olds after five weeks, and 1.8% of children and adolescents with confirmed/probable SARS-CoV-2 infection after two months.Long COVID often results in impairment of daily life with limited ability to go to school or to work, up to and including inability to go to school or to work.
Some patients manifest full-blown CFS, which has also been described after other viral infections, such as after glandular fever caused by Epstein-Bar virus (EBV).
Similar to post-COVID CFS, CFS after primary EBV infection manifests predominantly in female adolescents and young adults.
Whether it is the same severe, chronic disease despite similar clinical phenotype is uncertain.The mechanisms of pathogenesis of Long COVID and postinfectious CFS have been poorly elucidated.
Initial studies of Long COVID suggest that autoimmunity, chronic inflammation, endothelial dysfunction, and psychosocial aspects contribute to pathogenesis.
For postinfectious CFS, a causal interplay of genetic factors, stress, and infections has also been postulated, inducing a vicious cycle of dysregulation of the central and autonomic nervous system, immune defense, and metabolism.
Eligibility Criteria
Inclusion Criteria:I. Written consent of the patient or, in the case of children and adolescents, written consent of the patient and written consent of the legal guardian.II. condition following confirmed or highly probable SARS-CoV-2 infection:Detection of SARS-CoV-2 infection by polymerase chain reaction (PCR).Detection of SARS-CoV-2 infection by rapid antigen test (AST) in the context of matching COVID-19 symptoms.Clinical diagnosis of COVID-19 with the aid of typical CT findings or on the basis of a present olfactory and gustatory disturbance.History of high-risk contact with subsequent plausible COVID-19 symptomatology.Detection of anti-SARS-CoV-2-N and/or -S-IgG antibodies following anamnestic plausible COVID-19 symptomatology.Future valid biomarkersIII. suspected diagnosis according to ICD-10:U09.9 !
(V) Post-COVID-19 condition, unspecified.U12.9 !
(V) Adverse reactions to COVID-19 vaccine use, unspecified.Exclusion Criteria:Retrospectively available medical data that are not compatible with the inclusion criteria may lead to subsequent exclusion from the study.Patients whose entire clinical picture, but not individual symptoms, can be explained by another underlying disease according to WHO.Pregnancy
Source: ClinicalTrials.gov (NCT05638724). StuddyBuddy aggregates publicly available trial information.