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

NCT04366206 | Unknown

• 1 other identifier: GHTRB-2020-01
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID; SARS-CoV 2

Keywords

covid-19; SARS-Cov-2

Outcome Measures

Primary Outcomes (1)

• Composite of death and mechanical ventilation

  Composite of death and mechanical ventilation

  At 14-days follow-up

Secondary Outcomes (8)

• Need for mechanical ventilation

  At 14-days follow-up

• Death

  At 14-days follow-up

• Acute kidney injury

  At 14-days follow-up

• Acute respiratory distress syndrome

  At 14-days follow-up

• Cardiac arrhythmia and conduction disorder

  At 14-days follow-up

Study Arms (2)

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)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Robert Ballanger: lead
• Groupe Hospitalier Pitie-Salpetriere: collaborator

Study Sites (2)

Centre Hospitalier Intercommunal Robert Ballanger

Aulnay-sous-Bois, 93600, France

RECRUITING

Groupe Hospitalier Pitie Salpetriere

Paris, 75013, France

NOT YET RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hélène Gros, MD

  Robert Ballanger

  STUDY DIRECTOR

Central Study Contacts

Hélène Gros, MD

CONTACT

01 49 36 73 67; helene.gros@ght-gpne.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2020
• First Posted: April 28, 2020
• Study Start: March 14, 2020
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)