Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04778020
Status:
COMPLETED
Last Update Posted:
2022-01-18
First Post:
2021-02-20
Brief Title:
International COVID-19 Clinical Evaluation Registry -2 HOPE-2
Sponsor:
St Carlos Hospital Madrid Spain
Organization:
St Carlos Hospital Madrid Spain
Study Overview
Official Title:
International COVID-19 Clinical Evaluation Registry -2 HOPE-2
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOPE-2
Brief Summary:
PURPOSE The main objective of the present study is to carefully characterize the clinical profile of individuals with lasting sequelae after a COVID-19 admission
As secondary objectives the analysis of the risk-adjusted influence of COVID-19 severity previous comorbidities and management of patients discharged after COVID-19 will be performed
DESIGN AND STATISTICAL ANALYSIS Cross-sectional and prospective registry a real life all comers type with voluntary participation without specific funding or conflicts of interest
It is a study initiated by researcher that will have advanced statistical support from the IMAS foundation Institute for the Improvement of Health Care Madrid Spain and the Cardiovascular Research Foundation FIC Madrid Spain
International level
PARTICIPANTS PROTOCOL The study has been approved by Hospital Clinico San Carlos Ethics Committee 21128-E and the institutional board of each participating center
The present study proposes the continuation in time of the work previously carried out in the HOPE registry
It proposes to select all the patients attended in any health center with in hospital beds who have been discharged or have died up to 31st august 2020
All will be considered eligible with a positive COVID-19 test any type or if their attending physicians consider them highly likely to have presented the infection
Given the anonymous characteristics of the registry and the health alarm situation generated by the virus in principle it is not considered necessary to provide written informed consent
As secondary objectives the analysis of the risk-adjusted influence of COVID-19 severity previous comorbidities and management of patients discharged after COVID-19 will be performed
DESIGN AND STATISTICAL ANALYSIS Cross-sectional and prospective registry a real life all comers type with voluntary participation without specific funding or conflicts of interest
It is a study initiated by researcher that will have advanced statistical support from the IMAS foundation Institute for the Improvement of Health Care Madrid Spain and the Cardiovascular Research Foundation FIC Madrid Spain
International level
PARTICIPANTS PROTOCOL The study has been approved by Hospital Clinico San Carlos Ethics Committee 21128-E and the institutional board of each participating center
The present study proposes the continuation in time of the work previously carried out in the HOPE registry
It proposes to select all the patients attended in any health center with in hospital beds who have been discharged or have died up to 31st august 2020
All will be considered eligible with a positive COVID-19 test any type or if their attending physicians consider them highly likely to have presented the infection
Given the anonymous characteristics of the registry and the health alarm situation generated by the virus in principle it is not considered necessary to provide written informed consent
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None