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

Covid19 Clinical Trial

— HOPE-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04778020
• Other study ID #: 21/128-E
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: January 10, 2022

Study information

• Verified date: January 2022
• Source: St Carlos Hospital, Madrid, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9299
• Est. completion date: January 10, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Locations

Country	Name	City	State
Spain	Hospital Clinico San Carlos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
St Carlos Hospital, Madrid, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DEATH	Number of participants dead by any cause during follow up.	through study completion, an average of 1 year
Secondary	Any POSTCOVID-19 symptom	Events defined in HOPE 2 protocol	through study completion, an average of 1 year