Pediatric Intensive Care and COVID-19 — CLOVIS  

Covid19 Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Communicable Diseases
• Coronavirus Infections
• Covid19
• Critical Illness
• Infection
• Pediatric ALL
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

• NCT number: NCT04544878
• Study type: Observational [Patient Registry]
• Source: Bicetre Hospital
• Contact: Pierre Tissieres, MD, DSc
• Phone: +33145213205
• Email: pierre.tissieres@aphp.fr
• Status: Recruiting
• Start date: March 26, 2020
• Completion date: June 1, 2021