COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Pediatric Intensive Care and COVID-19 (CLOVIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04544878
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : September 10, 2020
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.

Layout table for study information
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

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 ]

  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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.

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 identifier (NCT number): NCT04544878

Layout table for location contacts
Contact: Pierre Tissieres, MD, DSc +33145213205
Contact: Clemence Marais, MD, MSc +33145213205

Layout table for location information
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   
Contact: Jordi Miatello, MD, MSc    +33145213205   
Sponsors and Collaborators
Bicetre Hospital
Layout table for investigator information
Principal Investigator: Pierre Tissieres, MD, DSc Bicêtre Hospital
Layout table for additonal information
Responsible Party: Pierre Tissieres, Professor, Bicetre Hospital 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

Layout table for additional information
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:
myeloid derived suppressor cell
Additional relevant MeSH terms:
Layout table for MeSH terms
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