Clinical trial NCT04659486: Adolescents With COVID-19/MIS-C at HCFMUSP
Official title: Prospective Studies in School-aged Children and Adolescents With COVID-19 Treated at HCFMUSP
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Corona Virus Infection
SARS (Severe Acute Respiratory Syndrome)
SARS-CoV Infection
Keywords: Covid19
Children
Adolescents
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Hospital das Clínicas da Faculdade de Medicina da USP
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2020-12-09
Enrollment: 100
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a protocol aimed at children and adolescents contaminated with COVID, treated at the Hospital das Clínicas, University of Sao Paulo, Brazil (HCFMUSP), in the recovery phase. The study aims to evaluate the spectrum of pathogenic lesions of the virus not only in the respiratory system, but digestive, immunological, neurological and others. Clinical, evolutionary, laboratory and functional parameters will be used.

Detailed description: School-age children and adolescents COVID-19 survivors may have persistent inflammation, a chronic course of COVID-19, with isolated or concomitant aggressions of various organs and systems, making this disease a potential chronic condition, impacting aspects of quality of life related to health (HRQoL), physical and mental health. In addition, pediatric COVID-19 can induce autoimmunity (with the possibility of primary hypothyroidism and type I diabetes mellitus), delayed linear growth and delayed pubertal development, secondary immunodeficiency and present genetic polymorphisms in brain plasticity impacting rehabilitation. School-aged children and adolescents with COVID-19 could present muscle weakness, dysautonomy, asthenia and physical inactivity, so it is essential that safe and effective interventions are developed to maintain adequate levels of physical activity and that they can be implemented on a large scale. However, to date, there are no systematic longitudinal studies that have evaluated all these aspects in a pediatric population that survived COVID-19, particularly with chronic conditions and who were hospitalized in a tertiary service.

Eligibility criteria: Inclusion Criteria:

* school-age children and adolescents diagnosed with COVID-19

Exclusion Criteria:

* school-age children and adolescents with MIS-C, who present: myocardial dysfunction, refractory cardiac arrhythmias, coronary artery aneurysms with or without thrombi, electrocardiographic alterations suggestive of myocardial infarction or ischemia and clinical signs of heart failure;
* presence of any limitation or physical disability that prevents the practice of exercise;
* pregnancy.

Primary outcomes:
measure: Quality of Life assessed by the Pediatric Quality of Life Inventory (Peds-QoL)
timeFrame: Change from Baseline at 3 months
measure: Quality of Life assessed by the Pediatric Quality of Life Inventory (Peds-QoL)
timeFrame: Change from Baseline at 6 months
Secondary outcomes:
measure: Flow-volume loop assessed by spirometry
timeFrame: Baseline, 3 months, 6 months
measure: Health-related quality of life assessed by the Pediatric Outcomes Data Collection Instrument
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Complete blood count (hemoglobin, leukocyte, lymphocyte and platelet count)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Inflammatory markers (C-reactive protein, fibrinogen, D-dimer and ferritin);
timeFrame: Baseline, 3 months, 6 months,12 months
measure: Lactate dehydrogenase
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Aspartate and alanine aminotransferase
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Serum urea and creatinine
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Triglycerides
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Creatinine phosphokinase (CK)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Amilase
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Lipase
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Troponin T
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Pro-BNP
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Lung abnormalities will be assessed by pulmonary computed tomography
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Systolic and diastolic function will be assessed by echocardiogram
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Valve dysfunction will be assessed by echocardiogram
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Pericardial effusion will be assessed by echocardiogram
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Coronary arteries will be assessed by echocardiogram
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Ischemia will be assessed by echocardiogram
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Immunocompetence, including thymic function
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Leukogram will be assessed by leukocyte and lymphocyte counts
timeFrame: Baseline, 3 months, 6 months,, 12 months
measure: Immunophenotyping of lymphocytes T cell lineages will be evaluated by flow cytometry
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Immunophenotyping of lymphocytes B cell lineages will be evaluated by flow cytometry
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Immunophenotyping of lymphocytes NK cells will be evaluated by flow cytometry
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Serum levels of anti-Streptococcus pneumoniae IgG antibodies
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Anti-pneumococcal vaccine response will be assessed by ELISA
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Evaluation of the thymus by the determination of TRECs (Thymic recent emigrant cells or T-cell receptor excision circles)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Changes in frequency of the autoantibodies of the thyroid gland
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Changes in frequency of the anti-GAD antibody will be assessed using immunoprecipitation
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Changes in frequency of the anti-islet antibody of Langerhans will be assessed using indirect fluorescence
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Changes in frequency of the anti-insulin antibody will be assessed by radioimmunoassay
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Diagnosis of thyroid dysfunction will be assessed by thyroid profile (TSH, free T4 and T3)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Diagnosis of type 1 diabetes mellitus will be assessed by the metabolic profile (fasting glucose, glycated hemoglobin and C peptide)
timeFrame: Baseline, 3 months, 6 months,, 12 months
measure: Linear growth will be assessed by using a standardized stadiometer, calculating standard deviation, growth curves, and growth speed
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Development of puberty will be assessed according to the criteria of Tanner and Marshall in adolescents in the prepubertal age group
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Bone age will be assessed using non-dominant hand and wrist radiography
timeFrame: Baseline, 12 months
measure: Bone mineral density will be assessed by Bone densitometry (DXA) in the region of the lumbar spine
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Bone mineral content will be assessed by Bone densitometry (DXA) in the region of the lumbar spine
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Bone mineral density will be assessed by Bone densitometry (DXA) in the proximal femur
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Bone mineral content will be assessed by Bone densitometry (DXA) in the proximal femur
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Bone mineral density will be assessed by Bone densitometry (DXA) in the whole body
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Bone mineral content will be assessed by Bone densitometry (DXA) in the whole body
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Body composition (visceral adipose tissue) will be assessed by Bone densitometry
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Body composition (lean mass) will be assessed by Bone densitometry
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Body composition (fat mass) will be assessed by Bone densitometry
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Bone biochemical and bone remodeling markers (calcium, phosphorus, 25OH alkaline phosphatase vitamin D, PTH, CTX, P1NP)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Pediatric gait assessment will be assessed by an Actigraph (3D accelerometer) model G-Walk used during the "timed up and go" test
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Pediatric gait assessment will be assessed by an Actigraph (3D accelerometer) model G-Walk during the 6-minute walk test
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Pediatric gait assessment will be assessed by an Actigraph (3D accelerometer) model G-Walk during the 10 meter gait test
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Pediatric gait assessment will be assessed by musculoskeletal ultrasound
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Genetic Polymorphism Analysis will be assessed by salting out methodology followed by q-PCR (Real-time PCR) using the TaqMan assay using Step One Plus equipment
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Mental health will be assessed by the "Strengths and Weaknesses of Attention-deficit/hyperactivity disorder (ADHD) symptoms and Normal behaviors"
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Mental health will be assessed by the "Strengths and Difficulties Questionnaire"
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Mental health will be assessed by the "Depression, Anxiety and Stress Scale"
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Physical activity levels assessed by ActivPAL
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Food consumption levels assessed by food records
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Blood flow will be assessed using a Doppler Ultrasound
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Endothelial function will be assessed using a Doppler Ultrasound
timeFrame: Baseline, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas Faculdade de Medicina USP
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Clovis Silva, PhD
role: STUDY_DIRECTOR
References: