International COVID19 Clinical Evaluation Registry, (HOPE COVID 19)

January 9, 2022 updated by: IVAN J NUÑEZ GIL

International COVID19 Clinical Evaluation Registry: HOPECOVID19. (Health Outcome Predictive Evaluation for COVID19)

The investigators propose to select all COVID 19 patients attended in any health center (with in hospital beds), who have been discharged or have died at the time of the evaluation.

The main objective of the present study is to carefully characterize the clinical profile of patients infected with COVID-19 in order to develop a simple prognostic clinical score allowing, in selected cases, rapid logistic decision making (discharge with follow-up, referral to provisional/field hospitals or admission to more complex hospital centers).

As secondary objectives, the analysis of the risk-adjusted influence of treatments and previous comorbidities of patients infected with the disease will be performed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

INTRODUCTION. The disease caused by the new respiratory virus (coronavirus) designated as SARS-CoV-2 has recently been classified as a pandemic by the WHO.

With an increasing number of confirmed cases in most countries worldwide, it is responsible for a significant morbidity and mortality and has motivated the implementation of measures at national and international levels with a great impact on the way of life of people throughout the whole planet.

In addition, this condition currently threatens many countries with the collapse of health systems, producing serious logistical problems due to extensive affectation of the population, which can worsen the prognosis of those primarily affected by COVID 19 and other patients with different pathologies and who may have difficulties to get healthcare.

Limited clinical information is available and generally limited to the Asian population, since the first cases were identified in Wuhan (Hubei, China).

PURPOSE. The main objective of the present study is to carefully characterize the clinical profile of patients infected with COVID-19 in order to develop a simple prognostic clinical score allowing, in selected cases, rapid logistic decision making (discharge with follow-up, referral to provisional/field hospitals or admission to more complex hospital centers).

As secondary objectives, the analysis of the risk-adjusted influence of treatments (ie. ACEIs, ARBs) and previous comorbidities of patients infected with the disease will be performed.

DESIGN AND STATISTICAL ANALYSIS Cross-sectional and ambispective registry, a real life "all comers" type, with voluntary participation, without 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), that will serve as statistical core.

International level.

PARTICIPANTS PROTOCOL. The study has been approved by Hospital Clinico San Carlos Ethic´s Committee (20/241-E) and the institutional board of each participating center. It has received an AEMPS classification (EPA-0D).

The researchers aimto select all the patients attended in any health center (with in hospital beds), who have been discharged or have died at the time of the evaluation.

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.

- Inclusion criteria Patients discharged (deceased or alive) from any hospital center with a confirmed diagnosis or a COVID-19 high suspicion.

There are no exclusion criteria, except for the patient's explicit refusal to participate.

DATA BASE. An anonymized database is presented in electronic format, to be filled in at each participating center (www.HopeProjectMD.com).

In theory, all information could be obtained from electronic records (medical history).

If deemed necessary, the investigator may call patients in order to establish their vital status (strongly warranted), as well as the results of the RNA test (or antibody) , if they were pending during their stay.

SAMPLE SIZE. It would not be possible to estimate for the sample size based on literature reports. Thus, HOPE will aim to get the maximum numbers of patients possible.

OUTCOMES. Primary: All-cause mortality. The major contributors of increased mortality will be assessed.

Secondary: In stay events, defined by the attending physician.

  • In hospital stay.
  • Heart failure.
  • Renal failure.
  • Respiratory Insufficiency.
  • Upper respiratory tract involvement.
  • Pneumonia.
  • Sepsis.
  • Systemic inflammatory response Syndrome.
  • Clinically relevant bleeding.
  • Hemoptysis.
  • Embolic event
  • Other complications.
  • Causes of death. Depending the results of the main interim analysis, the main DB could be slightly modified and several sub analyses could be proposed after sensitivity analyses.

Study Type

Observational

Enrollment (Actual)

8168

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Hospital Lclinico San Carlos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Confirmed diagnosis or a COVID-19 high suspicion.

Description

Inclusion Criteria:

  • Patients discharged (deceased or alive) from any hospital center with a confirmed diagnosis or a COVID-19 high suspicion.

Exclusion Criteria:

  • There are no exclusion criteria, except for the patient's explicit refusal to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: through study completion, an average of 1 month
All cause
through study completion, an average of 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In hospital stay.
Time Frame: through study completion, an average of 1 month
Days
through study completion, an average of 1 month
Heart failure
Time Frame: through study completion, an average of 1 month
According the attending physician.
through study completion, an average of 1 month
Renal failure
Time Frame: through study completion, an average of 1 month
According the attending physician.
through study completion, an average of 1 month
Respiratory Insufficiency.
Time Frame: through study completion, an average of 1 month
According the attending physician.
through study completion, an average of 1 month
Upper respiratory tract involvement
Time Frame: through study completion, an average of 1 month
According the attending physician.
through study completion, an average of 1 month
Pneumonia
Time Frame: through study completion, an average of 1 month
According the attending physician.
through study completion, an average of 1 month
Sepsis
Time Frame: through study completion, an average of 1 month
According the attending physician.
through study completion, an average of 1 month
Systemic inflammatory response Syndrome.
Time Frame: through study completion, an average of 1 month
According the attending physician.
through study completion, an average of 1 month
Clinically relevant bleeding
Time Frame: through study completion, an average of 1 month
According the attending physician.
through study completion, an average of 1 month
Other complications.
Time Frame: through study completion, an average of 1 month
According the attending physician.
through study completion, an average of 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IVAN J NUÑEZ GIL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2020

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

May 31, 2020

Study Registration Dates

First Submitted

April 1, 2020

First Submitted That Met QC Criteria

April 3, 2020

First Posted (Actual)

April 6, 2020

Study Record Updates

Last Update Posted (Actual)

January 25, 2022

Last Update Submitted That Met QC Criteria

January 9, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20/241-E
  • EUPAS34399 (Other Identifier: EMA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD are to be share among HOPE researchers. However, the HOPE Steering committee is open to collaborative proposals.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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