CLOVIS: Pediatric Intensive Care and COVID-19

Sponsor

Bicetre Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04544878

Collaborator

(none)

100

Enrollment

Location

14.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 Pediatric ALL Infection Critical Illness SARS-CoV Infection

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

Bone marrow analysis when indicated by attending staff.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 26, 2020

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Pediatric patients All term children from birth to 18 years of age admitted in the PICU
Adult patients All patients >18 years of age

Outcome Measures

Primary Outcome Measures

Number of patient with secondary infection [2 weeks]
Secondary infection will include healthcare associated infections as well as sepsis, and septic shock

Secondary Outcome Measures

Number of patients dying [7-day, 28-day and 60-day]
mortality
Description of clinical phenotypes [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 [through study completion, an average of 4 weeks]
Measure circulating cell phenotypes (relative percentage and monocyte classII histocompatibility complex

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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