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Clinical Trials/NCT04366206
NCT04366206
Unknown
Not Applicable

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

Centre Hospitalier Intercommunal Robert Ballanger2 sites in 1 country143 target enrollmentMarch 14, 2020
ConditionsCOVIDSARS-CoV 2

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID
Sponsor
Centre Hospitalier Intercommunal Robert Ballanger
Enrollment
143
Locations
2
Primary Endpoint
Composite of death and mechanical ventilation
Last Updated
6 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
March 14, 2020
End Date
July 31, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier Intercommunal Robert Ballanger
Responsible Party
Principal Investigator
Principal Investigator

Dr. Hélène GROS

Principal Investigator

Centre Hospitalier Intercommunal Robert Ballanger

Eligibility 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

Outcomes

Primary Outcomes

Composite of death and mechanical ventilation

Time Frame: At 14-days follow-up

Composite of death and mechanical ventilation

Secondary Outcomes

  • Death(At 14-days follow-up)
  • Need for mechanical ventilation(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)
  • Composite of death and mechanical ventilation(Up to 60 days after inclusion)
  • 60-days mortality(Up to 60 days after inclusion)
  • 60-days mechanical ventilation(Up to 60 days after inclusion)

Study Sites (2)

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