International COVID19 Clinical Evaluation Registry,

COVID 19 Clinical Trial

— HOPE COVID 19  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04334291
• Other study ID #: 20/241-E
• Secondary ID: EUPAS34399
• Status: Completed
• Start date: March 23, 2020
• Est. completion date: May 31, 2020

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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8168
• Est. completion date: May 31, 2020
• Est. primary completion date: May 1, 2020
• 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 or a COVID-19 high suspicion.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• COVID 19
• COVID-19

Intervention

Combination Product:
• Observational (registry)
Observational study.

Locations

Country	Name	City	State
Spain	Hospital Lclinico San Carlos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
IVAN J NUÑEZ GIL

Country where clinical trial is conducted

Spain, 

References & Publications (22)

Abumayyaleh M, Núñez Gil IJ, El-Battrawy I, Estrada V, Becerra-Muñoz VM, Aparisi A, Fernández-Rozas I, Feltes G, Arroyo-Espliguero R, Trabattoni D, López-País J, Pepe M, Romero R, García DRV, Biole C, Astrua TC, Eid CM, Alfonso E, Fernandez-Presa L, Espej — View Citation

Abumayyaleh M, Nuñez-Gil IJ, El-Battrawy I, Estrada V, Becerra-Muñoz VM, Uribarri A, Fernández-Rozas I, Feltes G, Arroyo-Espliguero R, Trabattoni D, López Pais J, Pepe M, Romero R, Ortega-Armas ME, Bianco M, Astrua TC, D'Ascenzo F, Fabregat-Andres O, Ball — View Citation

Becerra-Muñoz VM, Núñez-Gil IJ, Eid CM, García Aguado M, Romero R, Huang J, Mulet A, Ugo F, Rametta F, Liebetrau C, Aparisi A, Fernández-Rozas I, Viana-Llamas MC, Feltes G, Pepe M, Moreno-Rondón LA, Cerrato E, Raposeiras-Roubín S, Alfonso E, Carrero-Ferná — View Citation

Bertaina M, Nuñez-Gil IJ, Franchin L, Fernández Rozas I, Arroyo-Espliguero R, Viana-Llamas MC, Romero R, Maroun Eid C, Uribarri A, Becerra-Muñoz VM, Huang J, Alfonso E, Marmol-Mosquera F, Ugo F, Cerrato E, Fernandez-Presa L, Raposeiras Roubin S, Feltes Gu — View Citation

El-Battrawy I, Nuñez-Gil IJ, Abumayyaleh M, Estrada V, Manuel Becerra-Muñoz V, Uribarri A, Fernández-Rozas I, Feltes G, Arroyo-Espliguero R, Trabattoni D, López-País J, Pepe M, Romero R, Castro-Mejía AF, Cerrato E, Capel Astrua T, D'Ascenzo F, Fabregat-An — View Citation

Espejo-Paeres C, Núñez-Gil IJ, Estrada V, Fernández-Pérez C, Uribe-Heredia G, Cabré-Verdiell C, Uribarri A, Romero R, García-Aguado M, Fernández-Rozas I, Becerra-Muñoz V, Pepe M, Cerrato E, Raposeiras-Roubín S, Barrionuevo-Ramos M, Aveiga-Ligua F, Aguilar — View Citation

Núñez-Gil IJ, Estrada V, Fernández-Pérez C, Feltes G, Vedia O, Vergara-Uzcategui CE, Moreno-Menguía VH, Cerrato E, D'Ascenzo F, Raposeiras-Roubin S, Martín-Sánchez FJ, Alfonso-Rodríguez E, Huang J, Ramakrishna H, Gil-Higes E, Fernández-Ortiz A, Macaya C. Health Outcome Predictive Evaluation for COVID 19 international registry (HOPE COVID-19), rationale and design. Contemp Clin Trials Commun. 2020 Dec;20:100654. doi: 10.1016/j.conctc.2020.100654. Epub 2020 Sep 23. — View Citation

Núñez-Gil IJ, Estrada V, Fernández-Pérez C, Fernández-Rozas I, Martín-Sánchez FJ, Macaya C. The COVID-19 curve, health system overload, and mortality. Emergencias. 2020 Ago;32(4):293-295. English, Spanish. — View Citation

Núñez-Gil IJ, Fernández-Ortiz A, Maroud Eid C, Huang J, Romero R, Becerra-Muñoz VM, Uribarri A, Feltes G, Trabatoni D, Fernandez-Rozas I, Viana-Llamas MC, Pepe M, Cerrato E, Bertaina M, Capel Astrua T, Alfonso E, Castro-Mejía AF, Raposeiras-Roubin S, D'As — View Citation

Núñez-Gil IJ, Fernández-Pérez C, Estrada V, Becerra-Muñoz VM, El-Battrawy I, Uribarri A, Fernández-Rozas I, Feltes G, Viana-Llamas MC, Trabattoni D, López-País J, Pepe M, Romero R, Castro-Mejía AF, Cerrato E, Astrua TC, D'Ascenzo F, Fabregat-Andres O, Mor — View Citation

Núñez-Gil IJ, Olier I, Feltes G, Viana-Llamas MC, Maroun-Eid C, Romero R, Fernández-Rozas I, Uribarri A, Becerra-Muñoz VM, Alfonso-Rodriguez E, García-Aguado M, Elola J, Castro-Mejía A, Pepe M, Garcia-Prieto JF, Gonzalez A, Ugo F, Cerrato E, Bondia E, Rap — View Citation

Pepe M, Maroun-Eid C, Romero R, Arroyo-Espliguero R, Fernàndez-Rozas I, Aparisi A, Becerra-Muñoz VM, Garcìa Aguado M, Brindicci G, Huang J, Alfonso-Rodríguez E, Castro-Mejía AF, Favretto S, Cerrato E, Albiol P, Raposeiras-Roubin S, Vedia O, Feltes Guzmãn G, Carrero-Fernández A, Perez Cimarra C, Buzón L, Jativa Mendez JL, Abumayyaleh M, Corbi-Pascual M, Macaya C, Estrada V, Nestola PL, Biondi-Zoccai G, Núñez-Gil IJ. Clinical presentation, therapeutic approach, and outcome of young patients admitted for COVID-19, with respect to the elderly counterpart. Clin Exp Med. 2021 May;21(2):249-268. doi: 10.1007/s10238-021-00684-1. Epub 2021 Feb 8. — View Citation

Pérez-Segura P, Paz-Cabezas M, Núñez-Gil IJ, Arroyo-Espliguero R, Maroun Eid C, Romero R, Fernández Rozas I, Uribarri A, Becerra-Muñoz VM, García Aguado M, Huang J, Rondano E, Cerrato E, Rodríguez EA, Ortega-Armas ME, Raposeiras Roubin S, Pepe M, Feltes G — View Citation

Porta-Etessam J, Núñez-Gil IJ, González García N, Fernandez-Perez C, Viana-Llamas MC, Eid CM, Romero R, Molina M, Uribarri A, Becerra-Muñoz VM, Aguado MG, Huang J, Rondano E, Cerrato E, Alfonso E, Mejía AFC, Marin F, Roubin SR, Pepe M, Feltes G, Maté P, C — View Citation

Rivera-Caravaca JM, Núñez-Gil IJ, Vivas D, Viana-Llamas MC, Uribarri A, Becerra-Muñoz VM, Trabattoni D, Fernández Rozas I, Feltes G, López-Pais J, El-Battrawy I, Macaya C, Fernandez-Ortiz A, Estrada V, Marín F; HOPE COVID-19 Investigators. Clinical profil — View Citation

Ruiz-Sánchez JG, Núñez-Gil IJ, Cuesta M, Rubio MA, Maroun-Eid C, Arroyo-Espliguero R, Romero R, Becerra-Muñoz VM, Uribarri A, Feltes G, Trabattoni D, Molina M, García Aguado M, Pepe M, Cerrato E, Alfonso E, Castro Mejía AF, Roubin SR, Buzón L, Bondia E, M — View Citation

Salgado-Aranda R, Pérez-Castellano N, Núñez-Gil I, Orozco AJ, Torres-Esquivel N, Flores-Soler J, Chamaisse-Akari A, Mclnerney A, Vergara-Uzcategui C, Wang L, González-Ferrer JJ, Filgueiras-Rama D, Cañadas-Godoy V, Macaya-Miguel C, Pérez-Villacastín J. Inf — View Citation

Santoro F, Nuñez-Gil IJ, Vitale E, Viana-Llamas MC, Reche-Martinez B, Romero-Pareja R, Feltez Guzman G, Fernandez Rozas I, Uribarri A, Becerra-Muñoz VM, Alfonso-Rodriguez E, Garcia-Aguado M, Huang J, Ortega-Armas ME, Garcia Prieto JF, Corral Rubio EM, Ugo — View Citation

Signes-Costa J, Núñez-Gil IJ, Soriano JB, Arroyo-Espliguero R, Eid CM, Romero R, Uribarri A, Fernández-Rozas I, Aguado MG, Becerra-Muñoz VM, Huang J, Pepe M, Cerrato E, Raposeiras S, Gonzalez A, Franco-Leon F, Wang L, Alfonso E, Ugo F, García-Prieto JF, F — View Citation

Uribarri A, Núñez-Gil IJ, Aparisi Á, Arroyo-Espliguero R, Maroun Eid C, Romero R, Becerra-Muñoz VM, Feltes G, Molina M, García-Aguado M, Cerrato E, Capel-Astrua T, Alfonso-Rodríguez E, Castro-Mejía AF, Raposeiras-Roubín S, Espejo C, Pérez-Solé N, Bardají A, Marín F, Fabregat-Andrés Ó, D'ascenzo F, Santoro F, Akin I, Estrada V, Fernández-Ortiz A, Macaya C; HOPE COVID-19 investigators. Atrial fibrillation in patients with COVID-19. Usefulness of the CHA(2)DS(2)-VASc score: an analysis of the international HOPE COVID-19 registry. Rev Esp Cardiol (Engl Ed). 2021 Jul;74(7):608-615. doi: 10.1016/j.rec.2020.12.009. Epub 2021 Jan 13. English, Spanish. — View Citation

Uribarri A, Núñez-Gil IJ, Aparisi A, Becerra-Muñoz VM, Feltes G, Trabattoni D, Fernández-Rozas I, Viana-Llamas MC, Pepe M, Cerrato E, Capel-Astrua T, Romero R, Castro-Mejía AF, El-Battrawy I, López-País J, D'Ascenzo F, Fabregat-Andres O, Bardají A, Rapose — View Citation

Viana-Llamas MC, Arroyo-Espliguero R, Silva-Obregón JA, Uribe-Heredia G, Núñez-Gil I, García-Magallón B, Torán-Martínez CG, Castillo-Sandoval A, Díaz-Caraballo E, Rodríguez-Guinea I, Domínguez-López J. Hypoalbuminemia on admission in COVID-19 infection: A — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	All cause	through study completion, an average of 1 month
Secondary	In hospital stay.	Days	through study completion, an average of 1 month
Secondary	Heart failure	According the attending physician.	through study completion, an average of 1 month
Secondary	Renal failure	According the attending physician.	through study completion, an average of 1 month
Secondary	Respiratory Insufficiency.	According the attending physician.	through study completion, an average of 1 month
Secondary	Upper respiratory tract involvement	According the attending physician.	through study completion, an average of 1 month
Secondary	Pneumonia	According the attending physician.	through study completion, an average of 1 month
Secondary	Sepsis	According the attending physician.	through study completion, an average of 1 month
Secondary	Systemic inflammatory response Syndrome.	According the attending physician.	through study completion, an average of 1 month
Secondary	Clinically relevant bleeding	According the attending physician.	through study completion, an average of 1 month
Secondary	Other complications.	According the attending physician.	through study completion, an average of 1 month

External Links

•   HOPE WEB PAGE AND E-CRD