Pediatric Intensive Care and COVID-19

Covid19 Clinical Trial

— CLOVIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04544878
• Other study ID #: PS-PICRN--20001
• Status: Recruiting
• Start date: March 26, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: September 2020
• Source: Bicetre Hospital
• Contact: Pierre Tissieres, MD, DSc
• Phone: +33145213205
• Email: pierre.tissieres[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
France	Pediatric Intensive Care and Neonatal Medicine, Bicêtre Hospital, AP-HP PAris Saclay University	Le Kremlin-Bicêtre

Sponsors (1)

Lead Sponsor	Collaborator
Bicetre Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patient with secondary infection	Secondary infection will include healthcare associated infections as well as sepsis, and septic shock	2 weeks
Secondary	Number of patients dying	mortality	7-day, 28-day and 60-day
Secondary	Description of clinical phenotypes	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)	through study completion, an average of 4 weeks
Secondary	Description of immunological phenotypes	Measure circulating cell phenotypes (relative percentage and monocyte classII histocompatibility complex	through study completion, an average of 4 weeks