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

• Conditions: COVID; SARS-CoV 2

• Registration Number: NCT04366206
• Lead Sponsor: Centre Hospitalier Intercommunal Robert Ballanger

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.

Study Timeline

• Study Start: 2020-03-14
• Status Verified: 2020-04
• Study First Submitted: 2020-04-19
• Study First Submitted QC: 2020-04-27
• Last Update Submitted: 2020-04-27
• Study First Posted: 2020-04-28
• Last Update Posted: 2020-04-28
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 143

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of death and mechanical ventilation	At 14-days follow-up	Composite of death and mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
Need for mechanical ventilation	At 14-days follow-up	Need for mechanical ventilation
Death	At 14-days follow-up	All-cause mortality
Acute kidney injury	At 14-days follow-up	As defined by AKIN
Acute respiratory distress syndrome	At 14-days follow-up	As 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.
Cardiac arrhythmia and conduction disorder	At 14-days follow-up	Documented by EKG monitoring
Composite of death and mechanical ventilation	Up to 60 days after inclusion	Composite of death and mechanical ventilation
60-days mortality	Up to 60 days after inclusion	All cause mortality at 60 days follow-up whenever possible
60-days mechanical ventilation	Up to 60 days after inclusion	If patient was mechanically ventilated within 60 days of inclusion

Trial Locations

Locations (2)

Groupe Hospitalier Pitie Salpetriere; 🇫🇷 Paris, France

Centre Hospitalier Intercommunal Robert Ballanger; 🇫🇷 Aulnay-sous-Bois, France