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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04366206
Enrollment
143
Registered
2020-04-28
Start date
2020-03-14
Completion date
2020-07-31
Last updated
2020-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID, SARS-CoV 2

Keywords

covid-19, SARS-Cov-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.

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.

Interventions

None listed

Sponsors

Groupe Hospitalier Pitie-Salpetriere
CollaboratorOTHER
Centre Hospitalier Intercommunal Robert Ballanger
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Composite of death and mechanical ventilationAt 14-days follow-upComposite of death and mechanical ventilation

Secondary

MeasureTime frameDescription
Need for mechanical ventilationAt 14-days follow-upNeed for mechanical ventilation
DeathAt 14-days follow-upAll-cause mortality
Acute respiratory distress syndromeAt 14-days follow-upAs 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.
Acute kidney injuryAt 14-days follow-upAs defined by AKIN
Composite of death and mechanical ventilationUp to 60 days after inclusionComposite of death and mechanical ventilation
60-days mortalityUp to 60 days after inclusionAll cause mortality at 60 days follow-up whenever possible
60-days mechanical ventilationUp to 60 days after inclusionIf patient was mechanically ventilated within 60 days of inclusion
Cardiac arrhythmia and conduction disorderAt 14-days follow-upDocumented by EKG monitoring

Countries

France

Contacts

Primary ContactHélène Gros, MD
helene.gros@ght-gpne.fr01 49 36 73 67

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026