Skip to main content
Clinical Trials/NCT04778020
NCT04778020
Completed
Not Applicable

International COVID-19 Clinical Evaluation Registry -2 (HOPE-2)

St Carlos Hospital, Madrid, Spain1 site in 1 country9,299 target enrollmentMarch 1, 2021
ConditionsCovid19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
St Carlos Hospital, Madrid, Spain
Enrollment
9299
Locations
1
Primary Endpoint
DEATH
Status
Completed
Last Updated
4 years ago

Overview

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 Ethic´s Committee (21/128-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.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
January 10, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
St Carlos Hospital, Madrid, Spain
Responsible Party
Principal Investigator
Principal Investigator

IVAN J NUÑEZ GIL

MD, PhD, MSc. Principal Investigator

St Carlos Hospital, Madrid, Spain

Eligibility Criteria

Inclusion Criteria

  • Patients discharged (deceased or alive) from any hospital center with a confirmed diagnosis.

Exclusion Criteria

  • There are no exclusion criteria, except for the patient's explicit refusal to participate.

Outcomes

Primary Outcomes

DEATH

Time Frame: through study completion, an average of 1 year

Number of participants dead by any cause during follow up.

Secondary Outcomes

  • Any POSTCOVID-19 symptom(through study completion, an average of 1 year)

Study Sites (1)

Loading locations...

Similar Trials