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

NCT ID: NCT04778020

Last Updated: 2022-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9299 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-01-10

Brief Summary

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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.

Detailed Description

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Conditions

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Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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St Carlos Hospital, Madrid, Spain

OTHER

Sponsor Role lead

Responsible Party

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IVAN J NUÑEZ GIL

MD, PhD, MSc. Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Clinico San Carlos

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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21/128-E

Identifier Type: -

Identifier Source: org_study_id

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