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

COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04366206
• Other study ID #: GHTRB-2020-01
• Status: Recruiting
• Start date: March 14, 2020
• Est. completion date: July 31, 2020

Study information

• Verified date: April 2020
• Source: Centre Hospitalier Intercommunal Robert Ballanger
• Contact: Hélène Gros, MD
• Phone: 01 49 36 73 67
• Email: helene.gros[@]ght-gpne.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 143
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID
• SARS-CoV 2

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal Robert Ballanger	Aulnay-sous-Bois
France	Groupe Hospitalier Pitie Salpetriere	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Robert Ballanger	Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

Outcome

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