NCT04778020: HOPE-2

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

Completed Last updated 18 January 2022

What this trial tests

trial in Covid19 in 9,299 participants. Completed in 10 January 2022.

Timeline

1 March 2021

Primary endpoint
31 December 2021

10 January 2022

Quick facts

Lead sponsor	St Carlos Hospital, Madrid, Spain
Status	Completed
Study type	OBSERVATIONAL
Enrollment	9,299
Start date	1 March 2021
Primary completion	31 December 2021
Estimated completion	10 January 2022
Sites	1 location across Spain

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

St Carlos Hospital, Madrid, Spain

Who can join

Eligibility, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Post-COVID-19 Symptoms and Heart Disease: Incidence, Prognostic Factors, Outcomes and Vaccination: Results from a Multi-Center International Prospective Registry (HOPE 2).
   Núñez-Gil IJ, Feltes G, Viana-Llamas MC, Raposeiras-Roubin S, et al · · 2023 · cited 12× · PMID 36675633 · DOI 10.3390/jcm12020706
2. Elevated Troponins after COVID-19 Hospitalization and Long-Term COVID-19 Symptoms: Incidence, Prognosis, and Clinical Outcomes-Results from a Multi-Center International Prospective Registry (HOPE-2).
   Vazirani R, Feltes G, Hoyo RS, Viana-Llamas MC, et al · · 2024 · cited 5× · PMID 38731127 · DOI 10.3390/jcm13092596
3. The Long-Term Outcomes of Corticosteroid Use in COVID-19 Patients with Cardiovascular Disease: A Propensity-Matched Analysis from the Multi-Center International Prospective Registry (HOPE-2).
   García-Onrubia J, Vazirani R, Feltes G, Sánchez-Del Hoyo R, et al · · 2025 · PMID 41301758 · DOI 10.3390/biomedicines13112665