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

Sponsor

St Carlos Hospital, Madrid, Spain (Other)

Overall Status

Completed

CT.gov ID

NCT04778020

Collaborator

(none)

9,299

Enrollment

Location

10.3

Actual Duration (Months)

898.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

9299 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Jan 10, 2022

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clinico San Carlos	Madrid		Spain	28040

Sponsors and Collaborators

St Carlos Hospital, Madrid, Spain

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

IVAN J NUÑEZ GIL, MD, PhD, MSc. Principal Investigator, St Carlos Hospital, Madrid, Spain

ClinicalTrials.gov Identifier:

NCT04778020

Other Study ID Numbers:

21/128-E

First Posted:

Mar 2, 2021

Last Update Posted:

Jan 18, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Jan 18, 2022