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OpenTrials
Completed

NCT Number: NCT04778020

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. DEATH

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

    Number of participants dead by any cause during follow up.

Secondary outcomes

  1. Any POSTCOVID-19 symptom

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

    Events defined in HOPE 2 protocol

Sponsors and collaborators

Lead sponsor

St Carlos Hospital, Madrid, Spain

Other

Registry information

Acronym: HOPE-2

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 2, 2021
Registry last updated
Jan 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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