Clinical trial NCT04366206: Factors Associated With Clinical Outcomes in Patients Hospitalized for Covid-19 in GHT-93 Est
Official title: Factors Associated With Clinical Outcomes in Patients Hospitalized for Covid-19 in GHT-93 Est
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID
SARS-CoV 2
Keywords: covid-19
SARS-Cov-2
Lead sponsor: Centre Hospitalier Intercommunal Robert Ballanger
Sponsor class: OTHER
Collaborators: name: Groupe Hospitalier Pitie-Salpetriere
First posted: 2020-04-28
Enrollment: 143
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients hospitalized for Covid-19 may be eligible to join this cohort study

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.

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

Primary outcomes:
measure: Composite of death and mechanical ventilation
timeFrame: At 14-days follow-up
Secondary outcomes:
measure: Need for mechanical ventilation
timeFrame: At 14-days follow-up
measure: Death
timeFrame: At 14-days follow-up
measure: Acute kidney injury
timeFrame: At 14-days follow-up
measure: Acute respiratory distress syndrome
timeFrame: At 14-days follow-up
measure: Cardiac arrhythmia and conduction disorder
timeFrame: At 14-days follow-up
measure: Composite of death and mechanical ventilation
timeFrame: Up to 60 days after inclusion
measure: 60-days mortality
timeFrame: Up to 60 days after inclusion
measure: 60-days mechanical ventilation
timeFrame: Up to 60 days after inclusion
Other outcomes:
Locations:
city: Aulnay-sous-Bois
country: France
facility: Centre Hospitalier Intercommunal Robert Ballanger
city: Paris
country: France
facility: Groupe Hospitalier Pitie Salpetriere
Study officials:
affiliation: Robert Ballanger
name: Hélène Gros, MD
role: STUDY_DIRECTOR
References: