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

Sponsor

Centre Hospitalier Intercommunal Robert Ballanger (Other)

Overall Status

Unknown status

CT.gov ID

NCT04366206

Collaborator

Groupe Hospitalier Pitie-Salpetriere (Other)

143

Enrollment

Locations

4.6

Anticipated Duration (Months)

71.5

Patients Per Site

15.7

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
COVID SARS-CoV 2

Detailed Description

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

143 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 14, 2020

Anticipated Primary Completion Date :

Jul 31, 2020

Anticipated Study Completion Date :

Jul 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

Composite of death and mechanical ventilation [At 14-days follow-up]
Composite of death and mechanical ventilation

Secondary Outcome Measures

Need for mechanical ventilation [At 14-days follow-up]
Need for mechanical ventilation
Death [At 14-days follow-up]
All-cause mortality
Acute kidney injury [At 14-days follow-up]
As defined by AKIN
Acute respiratory distress syndrome [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.
Cardiac arrhythmia and conduction disorder [At 14-days follow-up]
Documented by EKG monitoring
Composite of death and mechanical ventilation [Up to 60 days after inclusion]
Composite of death and mechanical ventilation
60-days mortality [Up to 60 days after inclusion]
All cause mortality at 60 days follow-up whenever possible
60-days mechanical ventilation [Up to 60 days after inclusion]
If patient was mechanically ventilated within 60 days of inclusion

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Intercommunal Robert Ballanger	Aulnay-sous-Bois		France	93600
2	Groupe Hospitalier Pitie Salpetriere	Paris		France	75013

Sponsors and Collaborators

Centre Hospitalier Intercommunal Robert Ballanger
Groupe Hospitalier Pitie-Salpetriere

Investigators

Study Director: Hélène Gros, MD, Robert Ballanger

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Apr 28, 2020

Last Update Posted:

Apr 28, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Dr. Hélène GROS, Principal Investigator, Centre Hospitalier Intercommunal Robert Ballanger

covid-19

SARS-Cov-2

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Apr 28, 2020