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

NCT04778020 | Completed

• 1 other identifier: 21/128-E
• Study Type: observational
• Target: 9,299
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• DEATH

  Number of participants dead by any cause during follow up.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Any POSTCOVID-19 symptom

  through study completion, an average of 1 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Same inclusion/exclusion as HOPE COVID-19. We propose the long-term follow-up of patients discharged after a COVID-19 admission up to 31st august 2020. Consecutive inclusion and the completion of patients previously included in HOPE registry is strongly warranted.

You may qualify if:

• Patients discharged (deceased or alive) from any hospital center with a confirmed diagnosis.

Sponsors & Collaborators

• St Carlos Hospital, Madrid, Spain: lead

Study Sites (1)

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, MSc. Principal Investigator

Study Record Dates

• First Submitted: February 20, 2021
• First Posted: March 2, 2021
• Study Start: March 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: January 10, 2022
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After study termination

Locations

ES (1)