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Factors Associated With Clinical Outcomes in Patients Hospitalized for Covid-19 in GHT-93 Est

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ClinicalTrials.gov Identifier: NCT04366206
Recruitment Status : Recruiting
First Posted : April 28, 2020
Last Update Posted : April 28, 2020
Sponsor:
Collaborator:
Groupe Hospitalier Pitie-Salpetriere
Information provided by (Responsible Party):
Dr. Hélène GROS, Centre Hospitalier Intercommunal Robert Ballanger

Brief Summary:

Healthcare centers treated several hundreds of patients with Covid-19 and prospectively gathered information in electronic format between March, 2020 to April, 2020. In the course of Covid-19 treatment, physicians employed several drugs, including hydroxychloroquine, azithromycin, lopinavir/ritonavir, tocilizumab, baricitinib, sarilumab, corticosteroids and systematic antibiotics (list is not exhaustive).

This cohort study aims to assess factors associated with clinical outcomes in patients hospitalized for Covid-19, by analyzing associations between treatments and outcomes.

All data are collected in electronical records during routine practice.


Condition or disease
COVID SARS-CoV 2

Detailed Description:

Healthcare centers treated several hundreds of patients with Covid-19 and prospectively gathered information in electronic format between March, 2020 to April, 2020. In the course of Covid-19 treatment, physicians employed several drugs, including hydroxychloroquine, azithromycin, lopinavir/ritonavir, tocilizumab, baricitinib, sarilumab, corticosteroids and systematic antibiotics (list is not exhaustive).

This cohort study aims to assess factors associated with clinical outcomes in patients hospitalized for Covid-19.

Risk factors which will be studied include: baseline characteristics such as medical history and drugs with corresponding administration protocols.

Main outcomes include all-cause mortality, need for mechanical ventilation, for ICU transfer and all relevant biological syndromes.

All data are collected in electronical records during routine practice and additional data may be collected retrospectively.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 143 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 14 Weeks
Official Title: Factors Associated With Clinical Outcomes in Patients Hospitalized for Covid-19 in GHT-93 Est
Actual Study Start Date : March 14, 2020
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Group/Cohort
Patients exposed to the study variable
Depending on the studied variable (treatment or risk factor)
Patients not exposed to the study variable
Depending on the studied variable (treatment or risk factor)



Primary Outcome Measures :
  1. Composite of death and mechanical ventilation [ Time Frame: At 14-days follow-up ]
    Composite of death and mechanical ventilation


Secondary Outcome Measures :
  1. Need for mechanical ventilation [ Time Frame: At 14-days follow-up ]
    Need for mechanical ventilation

  2. Death [ Time Frame: At 14-days follow-up ]
    All-cause mortality

  3. Acute kidney injury [ Time Frame: At 14-days follow-up ]
    As defined by AKIN

  4. Acute respiratory distress syndrome [ Time Frame: At 14-days follow-up ]
    As defined by Berlin criteria: P/F ratio below 200, with PEEP > +5 cmH20, radiologic findings compatible with ARDS and not explained by heart failure, occurring within 7 days of an acute pulmonary or non-pulmonary aggression.

  5. Cardiac arrhythmia and conduction disorder [ Time Frame: At 14-days follow-up ]
    Documented by EKG monitoring

  6. Composite of death and mechanical ventilation [ Time Frame: Up to 60 days after inclusion ]
    Composite of death and mechanical ventilation

  7. 60-days mortality [ Time Frame: Up to 60 days after inclusion ]
    All cause mortality at 60 days follow-up whenever possible

  8. 60-days mechanical ventilation [ Time Frame: Up to 60 days after inclusion ]
    If patient was mechanically ventilated within 60 days of inclusion



Information from the National Library of Medicine

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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
All patients hospitalized for Covid-19 may be eligible to join this cohort study
Criteria

Inclusion Criteria:

  • hospitalized for Covid-19
  • severe pneumonia defined as pulse O2 < 96% despite > 6L/min

Exclusion Criteria:

  • lack of consent
  • palliative care patients
  • patients in ICU
  • patients transferred from ICU

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): NCT04366206


Contacts
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Contact: Hélène Gros, MD 01 49 36 73 67 ext +33 helene.gros@ght-gpne.fr

Locations
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France
Centre Hospitalier Intercommunal Robert Ballanger Recruiting
Aulnay-sous-Bois, France, 93600
Contact: Hélène Gros, MD    01 49 36 71 23 ext +33    helene.gros@ght-gpne.fr   
Contact: Benjamin Rossi, MD    01 49 36 71 23 ext +33    benjamin.rossi@ght-gpne.fr   
Groupe Hospitalier Pitie Salpetriere Not yet recruiting
Paris, France, 75013
Contact: Lee S Nguyen, MD, PhDc    01 42 17 85 31 ext +33    nguyen.lee@icloud.com   
Sponsors and Collaborators
Centre Hospitalier Intercommunal Robert Ballanger
Groupe Hospitalier Pitie-Salpetriere
Investigators
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Study Director: Hélène Gros, MD Robert Ballanger
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Responsible Party: Dr. Hélène GROS, Principal Investigator, Centre Hospitalier Intercommunal Robert Ballanger
ClinicalTrials.gov Identifier: NCT04366206    
Other Study ID Numbers: GHTRB-2020-01
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dr. Hélène GROS, Centre Hospitalier Intercommunal Robert Ballanger:
covid-19
SARS-Cov-2