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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
Sponsor:
Information provided by (Responsible Party):
Pierre Tissieres, Bicetre Hospital

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
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 6.
  • Bone marrow analysis when indicated by attending staff.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort
Pediatric patients
All term children from birth to 18 years of age admitted in the PICU
Adult patients
All patients >18 years of age



Primary Outcome Measures :
  1. Number of patient with secondary infection [ Time Frame: 2 weeks ]
    Secondary infection will include healthcare associated infections as well as sepsis, and septic shock


Secondary Outcome Measures :
  1. Number of patients dying [ Time Frame: 7-day, 28-day and 60-day ]
    mortality

  2. 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)

  3. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Most patients admitted in the PICU of Bicêtre Hospital are children <18 years old. Adults critically ill patients with COVID-19 were admitted in case of patients overflow in adult Intensive Care Unit.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Pierre Tissieres, MD, DSc +33145213205 pierre.tissieres@aphp.fr
Contact: Clemence Marais, MD, MSc +33145213205 clemence.marais@aphp.fr

Locations
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France
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    clemence.marais@aphp.fr   
Contact: Jordi Miatello, MD, MSc    +33145213205    jordi.miatello@aphp.fr   
Sponsors and Collaborators
Bicetre Hospital
Investigators
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Principal Investigator: Pierre Tissieres, MD, DSc Bicêtre Hospital
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Responsible Party: Pierre Tissieres, Professor, Bicetre Hospital
ClinicalTrials.gov Identifier: NCT04544878    
Other Study ID Numbers: PS-PICRN--20001
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pierre Tissieres, Bicetre Hospital:
Children
monitoring
immunodepression
HLA-DR
myeloid derived suppressor cell
neutrophil
phenotype
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Critical Illness
Disease Attributes
Pathologic Processes
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases