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

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.

Study Overview

• Status: Unknown
• Conditions: SARS-CoV 2; COVID

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.

• Study Type: Observational
• Enrollment (Anticipated): 143

Contacts and Locations

• Study Contact: Name: Hélène Gros, MD; Phone Number: +33 01 49 36 73 67; Email: helene.gros@ght-gpne.fr

Study Locations

• France
  • Aulnay-sous-Bois, France, 93600
    • Recruiting
    • Centre Hospitalier Intercommunal Robert Ballanger
    • Contact: Hélène Gros, MD; Phone Number: +33 01 49 36 71 23; Email: helene.gros@ght-gpne.fr
    • Contact: Benjamin Rossi, MD; Phone Number: +33 01 49 36 71 23; Email: benjamin.rossi@ght-gpne.fr
  • Paris, France, 75013
    • Not yet recruiting
    • Groupe Hospitalier Pitie Salpetriere
    • Contact: Lee S Nguyen, MD, PhDc; Phone Number: +33 01 42 17 85 31; Email: nguyen.lee@icloud.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of death and mechanical ventilation	Composite of death and mechanical ventilation	At 14-days follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Robert Ballanger
• Collaborators: Groupe Hospitalier Pitie-Salpetriere
• Investigators: Study Director: Hélène Gros, MD, Robert Ballanger

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2020
• Primary Completion (Anticipated): July 31, 2020
• Study Completion (Anticipated): July 31, 2020

Study Registration Dates

• First Submitted: April 19, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: covid-19; SARS-Cov-2
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: GHTRB-2020-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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