Pediatric Intensive Care and COVID-19 (CLOVIS)
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|ClinicalTrials.gov Identifier: NCT04544878|
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : September 10, 2020
|Condition or disease|
|Covid19 Pediatric ALL Infection Critical Illness SARS-CoV Infection|
All patients will be monitored during their PICU stay.
Clinical characteristics include: age, gender, co-morbidities, organ support therapies (mechanical ventilation, renal replacement therapy, extracorporeal membrane oxygenation, vasopressors), organ complications (pulmonary embolism, acute respiratory distress syndrome, renal failure, heart failure) and function, infective complications (ventilator associated pneumonia, central line associated bloodstream infection, pulmonary access, sepsis, septic shock), microbiologic and viral identification, 7-day and 28-day mortality.
Biological characteristics include:
- Admission workup: qualitative and quantitative Ig, ferritin, creatinine kinase, complement study (C3,C4,CH50),
- Daily workup: blood cells count, arterial blood gas analysis, lactate, electrolytes, albumin, blood urea nitrogen, creatinine, hemostasis (fibrinogen, factor V, II+VII, factor X, prothrombin time, antiXa activity, activated cephalin time, D-dimer), C-reactive protein, procalcitonin.
- Twice weekly workup: circulating cells phenotyping (T cell and subclass including Treg, B cell, Natural Killer cell, myeloid derived suppressor cell, neutrophils), interleukin 6.
- Bone marrow analysis when indicated by attending staff.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||16 Months|
|Official Title:||Clinical and Biological Characteristics of Critically Ill Patients With COVID-19 Admitted to Pediatric Intensive Care Unit|
|Actual Study Start Date :||March 26, 2020|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||June 1, 2021|
All term children from birth to 18 years of age admitted in the PICU
All patients >18 years of age
- Number of patient with secondary infection [ Time Frame: 2 weeks ]Secondary infection will include healthcare associated infections as well as sepsis, and septic shock
- Number of patients dying [ Time Frame: 7-day, 28-day and 60-day ]mortality
- Description of clinical phenotypes [ Time Frame: through study completion, an average of 4 weeks ]Description of the variable clinical phenotypes of COVID-19 in adults and children. This include COVID-19 respiratory failure, acute myocarditis and multi system inflammatory syndrome in children (MIS-C)
- Description of immunological phenotypes [ Time Frame: through study completion, an average of 4 weeks ]Measure circulating cell phenotypes (relative percentage and monocyte classII histocompatibility complex
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04544878
|Contact: Pierre Tissieres, MD, DScemail@example.com|
|Contact: Clemence Marais, MD, MScfirstname.lastname@example.org|
|Pediatric Intensive Care and Neonatal Medicine, Bicêtre Hospital, AP-HP PAris Saclay University||Recruiting|
|Le Kremlin-Bicêtre, France, 94275|
|Contact: Clemence Marais, MD, MSc +33145213205 email@example.com|
|Contact: Jordi Miatello, MD, MSc +33145213205 firstname.lastname@example.org|
|Principal Investigator:||Pierre Tissieres, MD, DSc||Bicêtre Hospital|