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Pediatric Intensive Care and COVID-19

Clinical and Biological Characteristics of Critically Ill Patients With COVID-19 Admitted to Pediatric Intensive Care Unit

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04544878
Acronym
CLOVIS
Enrollment
100
Registered
2020-09-10
Start date
2020-03-26
Completion date
2021-06-01
Last updated
2020-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Critical Illness, Infection, Pediatric ALL, SARS-CoV Infection

Keywords

Children, monitoring, immunodepression, HLA-DR, myeloid derived suppressor cell, neutrophil, phenotype

Brief summary

In this prospective longitudinal cohort the investigators reported the clinical, and biological characteristics of all critically ill patients admitted in the pediatric intensive care unit (PICU) of Bicêtre Hospital during the 2019 coronavirus disease (COVID-19) pandemics. Patients were older than 37 weeks of gestational age. No upper limit was set as the unit was transiently converted into a pediatric adult COVID-19 intensive care unit.

Detailed description

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.

Interventions

None listed

Sponsors

Bicetre Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients suspected or confirmed of severe acute respiratory syndrome Coronavirus 2 infection * No opposition from patients or legal representatives after study information * Patients admitted to the pediatric intensive care unit of Bicêtre Hospital, Assistance Publique Hôpitaux de Paris - Paris Saclay University * Between March 15, 2020 to June 31, 2021

Exclusion criteria

* Patient or legal representative refusal to participate

Design outcomes

Primary

MeasureTime frameDescription
Number of patient with secondary infection2 weeksSecondary infection will include healthcare associated infections as well as sepsis, and septic shock

Secondary

MeasureTime frameDescription
Number of patients dying7-day, 28-day and 60-daymortality
Description of clinical phenotypesthrough study completion, an average of 4 weeksDescription 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 phenotypesthrough study completion, an average of 4 weeksMeasure circulating cell phenotypes (relative percentage and monocyte classII histocompatibility complex

Countries

France

Contacts

Primary ContactPierre Tissieres, MD, DSc
pierre.tissieres@aphp.fr+33145213205
Backup ContactClemence Marais, MD, MSc
clemence.marais@aphp.fr+33145213205

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026