- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04659486
Adolescents With COVID-19/MIS-C at HCFMUSP
Prospective Studies in School-aged Children and Adolescents With COVID-19 Treated at HCFMUSP
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
SP
-
Sao Paulo, SP, Brazil
- Hospital das Clinicas Faculdade de Medicina USP
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Exercise training
A 12 weeks parallel-group randomized controlled trial will be performed, in which covid-19 survivors adolescents will complete a telemonitored home-based exercise training program, 3 times per week.
The training program will involve strength and aerobic exercises
|
Online strength and aerobic home-based exercise training, 3 times per week, for 12 weeks.
The exercise program is composed by 2 intensity-levels (starter and advanced).
|
NO_INTERVENTION: Control
The control group will receive all regular medical care and advice on healthy lifestyle including the promotion of recommended physical activity levels.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life assessed by the Pediatric Quality of Life Inventory (Peds-QoL)
Time Frame: Change from Baseline at 3 months
|
The instrument was translated and validated for the Brazilian population
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Change from Baseline at 3 months
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Quality of Life assessed by the Pediatric Quality of Life Inventory (Peds-QoL)
Time Frame: Change from Baseline at 6 months
|
The instrument was translated and validated for the Brazilian population
|
Change from Baseline at 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Flow-volume loop assessed by spirometry
Time Frame: Baseline, 3 months, 6 months
|
Aims to investigate the mechanisms that lead to dyspnea and, consequently, intolerance to physical effort
|
Baseline, 3 months, 6 months
|
Health-related quality of life assessed by the Pediatric Outcomes Data Collection Instrument
Time Frame: Baseline, 3 months, 6 months, 12 months
|
It will also be assessed for school-age children (7-10 years old) and adolescents (11-18 years old) and by their primary caregiver
|
Baseline, 3 months, 6 months, 12 months
|
Complete blood count (hemoglobin, leukocyte, lymphocyte and platelet count)
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
|
Inflammatory markers (C-reactive protein, fibrinogen, D-dimer and ferritin);
Time Frame: Baseline, 3 months, 6 months,12 months
|
Baseline, 3 months, 6 months,12 months
|
|
Lactate dehydrogenase
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
|
Aspartate and alanine aminotransferase
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
|
Serum urea and creatinine
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
|
Triglycerides
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
|
Creatinine phosphokinase (CK)
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
|
Amilase
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
|
Lipase
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
|
Troponin T
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
|
Pro-BNP
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
|
Lung abnormalities will be assessed by pulmonary computed tomography
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Patchy ground-glass opacities, crazy-paving pattern, and localization and pattern of large, confluent or small nodular lesions will be assessed
|
Baseline, 3 months, 6 months, 12 months
|
Systolic and diastolic function will be assessed by echocardiogram
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Conventional transthoracic echocardiogram with color Doppler to assess systolic and diastolic function
|
Baseline, 3 months, 6 months, 12 months
|
Valve dysfunction will be assessed by echocardiogram
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Conventional transthoracic echocardiogram with color Doppler to search for valve dysfunction
|
Baseline, 3 months, 6 months, 12 months
|
Pericardial effusion will be assessed by echocardiogram
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Conventional transthoracic echocardiogram with color Doppler to search for pericardial effusion
|
Baseline, 3 months, 6 months, 12 months
|
Coronary arteries will be assessed by echocardiogram
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Conventional transthoracic echocardiogram with color Doppler to search for aspects of the coronary arteries
|
Baseline, 3 months, 6 months, 12 months
|
Ischemia will be assessed by echocardiogram
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Echocardiogram with two-dimensional speckle-tracking technique to identify subclinical changes suggestive of ischemia or myocarditis
|
Baseline, 3 months, 6 months, 12 months
|
Immunocompetence, including thymic function
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline levels of cytokines IL-2, IL-4, IL-6, IL-10, TNF-alpha, IFN-y, and IL-17A in serum samples will be tested by flow cytometry using the CBA technique (Cytometric bead array, BD Biosciences)
|
Baseline, 3 months, 6 months, 12 months
|
Leukogram will be assessed by leukocyte and lymphocyte counts
Time Frame: Baseline, 3 months, 6 months,, 12 months
|
Baseline, 3 months, 6 months,, 12 months
|
|
Immunophenotyping of lymphocytes T cell lineages will be evaluated by flow cytometry
Time Frame: Baseline, 3 months, 6 months, 12 months
|
T cell lineages: CD3CD4, CD3CD8, naive cells (CD45RA+), memory cells (CD45RA-), effector cells (CD38+HLADR+)
|
Baseline, 3 months, 6 months, 12 months
|
Immunophenotyping of lymphocytes B cell lineages will be evaluated by flow cytometry
Time Frame: Baseline, 3 months, 6 months, 12 months
|
B cell lineages: CD19, naive cells (CD27-), memory cells (CD27+), plasmablasts (CD27+CD38+CD138-), (plasmocytes CD27+CD38+CD138+)
|
Baseline, 3 months, 6 months, 12 months
|
Immunophenotyping of lymphocytes NK cells will be evaluated by flow cytometry
Time Frame: Baseline, 3 months, 6 months, 12 months
|
NK cells: (CD3-CD16+CD56+), degranulated: CD107a+
|
Baseline, 3 months, 6 months, 12 months
|
Serum levels of anti-Streptococcus pneumoniae IgG antibodies
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
|
Anti-pneumococcal vaccine response will be assessed by ELISA
Time Frame: Baseline, 3 months, 6 months, 12 months
|
The antipneumococcal antibody titer against 6 polysaccharides (serotypes 1, 5, 6B, 9V, 14, and 18C) will be analyzed by ELISA.
The seroconversion criteria is IgG values > 1.3 mg/mL for each polysaccharide assessed
|
Baseline, 3 months, 6 months, 12 months
|
Evaluation of the thymus by the determination of TRECs (Thymic recent emigrant cells or T-cell receptor excision circles)
Time Frame: Baseline, 3 months, 6 months, 12 months
|
TRECs evaluate the peripheral function of the thymus from cells that have recently been released, using the RT-PCR technique
|
Baseline, 3 months, 6 months, 12 months
|
Changes in frequency of the autoantibodies of the thyroid gland
Time Frame: Baseline, 3 months, 6 months, 12 months
|
(anti-thyroperoxidase antibodies, anti-thyroglobulin)
|
Baseline, 3 months, 6 months, 12 months
|
Changes in frequency of the anti-GAD antibody will be assessed using immunoprecipitation
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
|
Changes in frequency of the anti-islet antibody of Langerhans will be assessed using indirect fluorescence
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
|
Changes in frequency of the anti-insulin antibody will be assessed by radioimmunoassay
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
|
Diagnosis of thyroid dysfunction will be assessed by thyroid profile (TSH, free T4 and T3)
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
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Diagnosis of type 1 diabetes mellitus will be assessed by the metabolic profile (fasting glucose, glycated hemoglobin and C peptide)
Time Frame: Baseline, 3 months, 6 months,, 12 months
|
Baseline, 3 months, 6 months,, 12 months
|
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Linear growth will be assessed by using a standardized stadiometer, calculating standard deviation, growth curves, and growth speed
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
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Development of puberty will be assessed according to the criteria of Tanner and Marshall in adolescents in the prepubertal age group
Time Frame: Baseline, 3 months, 6 months, 12 months
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Baseline, 3 months, 6 months, 12 months
|
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Bone age will be assessed using non-dominant hand and wrist radiography
Time Frame: Baseline, 12 months
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Baseline, 12 months
|
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Bone mineral density will be assessed by Bone densitometry (DXA) in the region of the lumbar spine
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
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Bone mineral content will be assessed by Bone densitometry (DXA) in the region of the lumbar spine
Time Frame: Baseline, 3 months, 6 months, 12 months
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Baseline, 3 months, 6 months, 12 months
|
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Bone mineral density will be assessed by Bone densitometry (DXA) in the proximal femur
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
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Bone mineral content will be assessed by Bone densitometry (DXA) in the proximal femur
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
|
Bone mineral density will be assessed by Bone densitometry (DXA) in the whole body
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
|
Bone mineral content will be assessed by Bone densitometry (DXA) in the whole body
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
|
Body composition (visceral adipose tissue) will be assessed by Bone densitometry
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
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Body composition (lean mass) will be assessed by Bone densitometry
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
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Body composition (fat mass) will be assessed by Bone densitometry
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
|
Bone biochemical and bone remodeling markers (calcium, phosphorus, 25OH alkaline phosphatase vitamin D, PTH, CTX, P1NP)
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
|
Pediatric gait assessment will be assessed by an Actigraph (3D accelerometer) model G-Walk used during the "timed up and go" test
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
|
Pediatric gait assessment will be assessed by an Actigraph (3D accelerometer) model G-Walk during the 6-minute walk test
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
|
Pediatric gait assessment will be assessed by an Actigraph (3D accelerometer) model G-Walk during the 10 meter gait test
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
|
Pediatric gait assessment will be assessed by musculoskeletal ultrasound
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline, 3 months, 6 months, 12 months
|
|
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
Time Frame: Baseline, 3 months, 6 months, 12 months
|
According to the gene sequence studied, the analysis will be performed using the Sanger sequencing technique with capillary electrophoresis in a 3130 automatic sequencer (Applied Biosystems). The genetic polymorphisms of the ABO system gene (rs505922), two polymorphisms of the OPRM1 gene (rs1799971 and rs1799972) and a polymorphism of the BDNF gene (rs6265) will be investigated, with possible contributions to the risk of impaired gait. |
Baseline, 3 months, 6 months, 12 months
|
Mental health will be assessed by the "Strengths and Weaknesses of Attention-deficit/hyperactivity disorder (ADHD) symptoms and Normal behaviors"
Time Frame: Baseline, 3 months, 6 months, 12 months
|
This is an 18-item parent questionnaire for children and adolescents (18 years and younger).
This rating scale includes positive "weaknesses" and negative "strengths" scoring, assessing symptoms of Attention-Deficit/Hyperactivity Disorder.
Parents are asked to compare their child's behavior in a variety of settings over the past month to other children on a 7-point: 3-Far below, 2-Below, 1-Slightly below, 0-Average, -1-Slightly average, -2-Above, -3-Far above.
Higher scores indicate greater symptomology
|
Baseline, 3 months, 6 months, 12 months
|
Mental health will be assessed by the "Strengths and Difficulties Questionnaire"
Time Frame: Baseline, 3 months, 6 months, 12 months
|
The Strengths and Difficulties Questionnaire (SDQ) is a brief behavioural screening questionnaire, and includes 25 items on psychological attribute: emotional symptoms (5 items), conduct problems (5 items) hyperactivity/inattention (5 items), peer relationship problems (5 items), prosocial behaviour (5 items).
Higher scores indicate greater difficulties
|
Baseline, 3 months, 6 months, 12 months
|
Mental health will be assessed by the "Depression, Anxiety and Stress Scale"
Time Frame: Baseline, 3 months, 6 months, 12 months
|
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress (7 items each subscale).
Patients are asked to score every item on a scale from 0 (did not apply to me at all) to 3 (applied to me very much).
Sum scores for the total DASS-total scale range between 0 and 120.
Scores ≥60 (for DASS-total) and ≥21 (for the depression subscale) are labeled as "high" or "severe".
|
Baseline, 3 months, 6 months, 12 months
|
Physical activity levels assessed by ActivPAL
Time Frame: Baseline, 3 months, 6 months, 12 months
|
ActivPAL will be used for 7 days for at least 10 hours/day
|
Baseline, 3 months, 6 months, 12 months
|
Food consumption levels assessed by food records
Time Frame: Baseline, 3 months, 6 months, 12 months
|
24-hour recalls will be assessed on three non-consecutive days (two weekdays, and one weekend).
Online Dietbox will be used.
|
Baseline, 3 months, 6 months, 12 months
|
Blood flow will be assessed using a Doppler Ultrasound
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Baseline blood flow measurements will be assessed in the brachial artery
|
Baseline, 3 months, 6 months, 12 months
|
Endothelial function will be assessed using a Doppler Ultrasound
Time Frame: Baseline, 3 months, 6 months, 12 months
|
Flow-mediated vasodilation (VMF) will be assessed in the brachial artery
|
Baseline, 3 months, 6 months, 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Clovis Silva, PhD, University of Sao Paulo
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Disease Attributes
- Severe Acute Respiratory Syndrome
- COVID-19
- Coronavirus Infections
- Infections
- Communicable Diseases
Other Study ID Numbers
- 37460620.8.0000.0068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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