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

Completed

• Conditions: Covid19

• Registration Number: NCT04778020
• Lead Sponsor: St Carlos Hospital, Madrid, Spain

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-20
• Study First Submitted QC: 2021-02-27
• Study Start: 2021-03-01
• Study First Posted: 2021-03-02
• Primary Completion: 2021-12-31
• Status Verified: 2022-01
• Study Completion: 2022-01-10
• Last Update Submitted: 2022-01-14
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9299

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DEATH	through study completion, an average of 1 year	Number of participants dead by any cause during follow up.

Secondary Outcome Measures

Name	Time	Method
Any POSTCOVID-19 symptom	through study completion, an average of 1 year	Events defined in HOPE 2 protocol

Trial Locations

Locations (1)

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain