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

NCT ID: NCT04366206

Last Updated: 2020-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

143 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-14

Study Completion Date

2020-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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COVID SARS-CoV 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients exposed to the study variable

Depending on the studied variable (treatment or risk factor)

No interventions assigned to this group

Patients not exposed to the study variable

Depending on the studied variable (treatment or risk factor)

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role collaborator

Centre Hospitalier Intercommunal Robert Ballanger

OTHER

Sponsor Role lead

Responsible Party

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Dr. Hélène GROS

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hélène Gros, MD

Role: STUDY_DIRECTOR

Robert Ballanger

Locations

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Centre Hospitalier Intercommunal Robert Ballanger

Aulnay-sous-Bois, , France

Site Status RECRUITING

Groupe Hospitalier Pitie Salpetriere

Paris, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Hélène Gros, MD

Role: CONTACT

01 49 36 73 67 ext. +33

Facility Contacts

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Hélène Gros, MD

Role: primary

01 49 36 71 23 ext. +33

Benjamin Rossi, MD

Role: backup

01 49 36 71 23 ext. +33

Lee S Nguyen, MD, PhDc

Role: primary

01 42 17 85 31 ext. +33

Other Identifiers

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GHTRB-2020-01

Identifier Type: -

Identifier Source: org_study_id

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