COVID 19HOPE COVID 19NCT04334291
International COVID19 Clinical Evaluation Registry,
An observational study of COVID 19, run by IVAN J NUÑEZ GIL at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID 19
- What is being tested?
- Observational (registry)
- How many people
- 8,168 participants
- Where
- 1 siteSpain
- Study dates
- 23 Mar 2020to 31 May 2020
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Confirmed diagnosis or a COVID-19 high suspicion.
Who may be able to join
- Patients discharged (deceased or alive) from any hospital center with a confirmed diagnosis or a COVID-19 high suspicion.
Who cannot join
- There are no exclusion criteria, except for the patient's explicit refusal to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID 19
- Being tested
- Observational (registry)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational (registry)Combination product
Observational study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
All cause
Measured: through study completion, an average of 1 month
Secondary outcomes (10)
In hospital stay.
Days
Measured: through study completion, an average of 1 month
Heart failure
According the attending physician.
Measured: through study completion, an average of 1 month
Renal failure
According the attending physician.
Measured: through study completion, an average of 1 month
Respiratory Insufficiency.
According the attending physician.
Measured: through study completion, an average of 1 month
Upper respiratory tract involvement
According the attending physician.
Measured: through study completion, an average of 1 month
Pneumonia
According the attending physician.
Measured: through study completion, an average of 1 month
Sepsis
According the attending physician.
Measured: through study completion, an average of 1 month
Systemic inflammatory response Syndrome.
According the attending physician.
Measured: through study completion, an average of 1 month
Clinically relevant bleeding
According the attending physician.
Measured: through study completion, an average of 1 month
Other complications.
According the attending physician.
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start23 Mar 2020
- Primary completion1 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for COVID 19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 8,168 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- IVAN J NUÑEZ GIL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, IVAN J NUÑEZ GIL, St Carlos Hospital, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334291
- Sponsor's protocol ID
- 20/241-E
- Other IDs
- EUPAS34399
- Acronym
- HOPE COVID 19
- Status last verified
- Jan 2022
- First submitted
- 1 Apr 2020
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD are to be share among HOPE researchers. However, the HOPE Steering committee is open to collaborative proposals.
Publications
Nunez-Gil IJ, Estrada V, Fernandez-Perez C, Feltes G, Vedia O, Vergara-Uzcategui CE, Moreno-Menguia VH, Cerrato E, D'Ascenzo F, Raposeiras-Roubin S, Martin-Sanchez FJ, Alfonso-Rodriguez E, Huang J, Ramakrishna H, Gil-Higes E, Fernandez-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.
PubMed 32989425Uribarri A, Nunez-Gil IJ, Aparisi A, Arroyo-Espliguero R, Maroun Eid C, Romero R, Becerra-Munoz VM, Feltes G, Molina M, Garcia-Aguado M, Cerrato E, Capel-Astrua T, Alfonso-Rodriguez E, Castro-Mejia AF, Raposeiras-Roubin S, Espejo C, Perez-Sole N, Bardaji A, Marin F, Fabregat-Andres O, D'ascenzo F, Santoro F, Akin I, Estrada V, Fernandez-Ortiz A, Macaya C; HOPE COVID-19 investigators. Atrial fibrillation in patients with COVID-19. Usefulness of the CHA2DS2-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.
PubMed 33583755Pepe M, Maroun-Eid C, Romero R, Arroyo-Espliguero R, Fernandez-Rozas I, Aparisi A, Becerra-Munoz VM, Garcia Aguado M, Brindicci G, Huang J, Alfonso-Rodriguez E, Castro-Mejia AF, Favretto S, Cerrato E, Albiol P, Raposeiras-Roubin S, Vedia O, Feltes Guzman G, Carrero-Fernandez A, Perez Cimarra C, Buzon L, Jativa Mendez JL, Abumayyaleh M, Corbi-Pascual M, Macaya C, Estrada V, Nestola PL, Biondi-Zoccai G, Nunez-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.
PubMed 33555436Rivera-Caravaca JM, Nunez-Gil IJ, Vivas D, Viana-Llamas MC, Uribarri A, Becerra-Munoz VM, Trabattoni D, Fernandez Rozas I, Feltes G, Lopez-Pais J, El-Battrawy I, Macaya C, Fernandez-Ortiz A, Estrada V, Marin F; HOPE COVID-19 Investigators. Clinical profile and prognosis in patients on oral anticoagulation before admission for COVID-19. Eur J Clin Invest. 2021 Jan;51(1):e13436. doi: 10.1111/eci.13436. Epub 2020 Nov 7.
PubMed 33080051Nunez-Gil IJ, Fernandez-Perez C, Estrada V, Becerra-Munoz VM, El-Battrawy I, Uribarri A, Fernandez-Rozas I, Feltes G, Viana-Llamas MC, Trabattoni D, Lopez-Pais J, Pepe M, Romero R, Castro-Mejia AF, Cerrato E, Astrua TC, D'Ascenzo F, Fabregat-Andres O, Moreu J, Guerra F, Signes-Costa J, Marin F, Buosenso D, Bardaji A, Raposeiras-Roubin S, Elola J, Molino A, Gomez-Doblas JJ, Abumayyaleh M, Aparisi A, Molina M, Guerri A, Arroyo-Espliguero R, Assanelli E, Mapelli M, Garcia-Acuna JM, Brindicci G, Manzone E, Ortega-Armas ME, Bianco M, Trung CP, Nunez MJ, Castellanos-Lluch C, Garcia-Vazquez E, Cabello-Clotet N, Jamhour-Chelh K, Tellez MJ, Fernandez-Ortiz A, Macaya C; HOPE COVID-19 Investigators. Mortality risk assessment in Spain and Italy, insights of the HOPE COVID-19 registry. Intern Emerg Med. 2021 Jun;16(4):957-966. doi: 10.1007/s11739-020-02543-5. Epub 2020 Nov 9.
PubMed 33165755Nunez-Gil IJ, Estrada V, Fernandez-Perez C, Fernandez-Rozas I, Martin-Sanchez FJ, Macaya C. The COVID-19 curve, health system overload, and mortality. Emergencias. 2020 Ago;32(4):293-295. No abstract available. English, Spanish.
PubMed 32692012Uribarri A, Nunez-Gil IJ, Aparisi A, Becerra-Munoz VM, Feltes G, Trabattoni D, Fernandez-Rozas I, Viana-Llamas MC, Pepe M, Cerrato E, Capel-Astrua T, Romero R, Castro-Mejia AF, El-Battrawy I, Lopez-Pais J, D'Ascenzo F, Fabregat-Andres O, Bardaji A, Raposeiras-Roubin S, Marin F, Fernandez-Ortiz A, Macaya C, Estrada V; HOPE COVID-19 Investigators. Impact of renal function on admission in COVID-19 patients: an analysis of the international HOPE COVID-19 (Health Outcome Predictive Evaluation for COVID 19) Registry. J Nephrol. 2020 Aug;33(4):737-745. doi: 10.1007/s40620-020-00790-5. Epub 2020 Jun 29.
PubMed 32602006Nunez-Gil IJ, Fernandez-Ortiz A, Maroud Eid C, Huang J, Romero R, Becerra-Munoz 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-Mejia AF, Raposeiras-Roubin S, D'Ascenzo F, Espejo Paeres C, Signes-Costa J, Bardaji A, Fernandez-Perez C, Marin F, Fabregat-Andres O, Akin I, Estrada V, Macaya C. Underlying heart diseases and acute COVID-19 outcomes. Cardiol J. 2021;28(2):202-214. doi: 10.5603/CJ.a2020.0183. Epub 2020 Dec 21.
PubMed 33346365Becerra-Munoz VM, Nunez-Gil IJ, Eid CM, Garcia Aguado M, Romero R, Huang J, Mulet A, Ugo F, Rametta F, Liebetrau C, Aparisi A, Fernandez-Rozas I, Viana-Llamas MC, Feltes G, Pepe M, Moreno-Rondon LA, Cerrato E, Raposeiras-Roubin S, Alfonso E, Carrero-Fernandez A, Buzon-Martin L, Abumayyaleh M, Gonzalez A, Fernandez Ortiz A, Macaya C, Estrada V, Fernandez-Perez C, Gomez-Doblas JJ. Clinical profile and predictors of in-hospital mortality among older patients hospitalised for COVID-19. Age Ageing. 2021 Feb 26;50(2):326-334. doi: 10.1093/ageing/afaa258.
PubMed 33201181Ruiz-Sanchez JG, Nunez-Gil IJ, Cuesta M, Rubio MA, Maroun-Eid C, Arroyo-Espliguero R, Romero R, Becerra-Munoz VM, Uribarri A, Feltes G, Trabattoni D, Molina M, Garcia Aguado M, Pepe M, Cerrato E, Alfonso E, Castro Mejia AF, Roubin SR, Buzon L, Bondia E, Marin F, Lopez Pais J, Abumayyaleh M, D'Ascenzo F, Rondano E, Huang J, Fernandez-Perez C, Macaya C, de Miguel Novoa P, Calle-Pascual AL, Estrada Perez V, Runkle I; HOPE COVID-19 investigators. Prognostic Impact of Hyponatremia and Hypernatremia in COVID-19 Pneumonia. A HOPE-COVID-19 (Health Outcome Predictive Evaluation for COVID-19) Registry Analysis. Front Endocrinol (Lausanne). 2020 Nov 30;11:599255. doi: 10.3389/fendo.2020.599255. eCollection 2020.
PubMed 33329400El-Battrawy I, Nunez-Gil IJ, Abumayyaleh M, Estrada V, Manuel Becerra-Munoz V, Uribarri A, Fernandez-Rozas I, Feltes G, Arroyo-Espliguero R, Trabattoni D, Lopez-Pais J, Pepe M, Romero R, Castro-Mejia AF, Cerrato E, Capel Astrua T, D'Ascenzo F, Fabregat-Andres O, Signes-Costa J, Marin F, Buonsenso D, Bardaji A, Jesus Tellez M, Fernandez-Ortiz A, Macaya C, Akin I. COVID-19 and the impact of arterial hypertension-An analysis of the international HOPE COVID-19 Registry (Italy-Spain-Germany). Eur J Clin Invest. 2021 Nov;51(11):e13582. doi: 10.1111/eci.13582. Epub 2021 Aug 19.
PubMed 34409593Signes-Costa J, Nunez-Gil IJ, Soriano JB, Arroyo-Espliguero R, Eid CM, Romero R, Uribarri A, Fernandez-Rozas I, Aguado MG, Becerra-Munoz VM, Huang J, Pepe M, Cerrato E, Raposeiras S, Gonzalez A, Franco-Leon F, Wang L, Alfonso E, Ugo F, Garcia-Prieto JF, Feltes G, Abumayyaleh M, Espejo-Paeres C, Jativa J, Masjuan AL, Macaya C, Carbonell Asins JA, Estrada V; HOPE COVID-19 investigators. Prevalence and 30-Day Mortality in Hospitalized Patients With Covid-19 and Prior Lung Diseases. Arch Bronconeumol. 2021 Apr;57:13-20. doi: 10.1016/j.arbres.2020.11.012. Epub 2020 Dec 16.
PubMed 34629634Santoro F, Nunez-Gil IJ, Vitale E, Viana-Llamas MC, Reche-Martinez B, Romero-Pareja R, Feltez Guzman G, Fernandez Rozas I, Uribarri A, Becerra-Munoz VM, Alfonso-Rodriguez E, Garcia-Aguado M, Huang J, Ortega-Armas ME, Garcia Prieto JF, Corral Rubio EM, Ugo F, Bianco M, Mulet A, Raposeiras-Roubin S, Jativa Mendez JL, Espejo Paeres C, Albarran AR, Marin F, Guerra F, Akin I, Cortese B, Ramakrishna H, Macaya C, Fernandez-Ortiz A, Brunetti ND. Antiplatelet therapy and outcome in COVID-19: the Health Outcome Predictive Evaluation Registry. Heart. 2022 Jan;108(2):130-136. doi: 10.1136/heartjnl-2021-319552. Epub 2021 Oct 5.
PubMed 34611045Nunez-Gil IJ, Olier I, Feltes G, Viana-Llamas MC, Maroun-Eid C, Romero R, Fernandez-Rozas I, Uribarri A, Becerra-Munoz VM, Alfonso-Rodriguez E, Garcia-Aguado M, Elola J, Castro-Mejia A, Pepe M, Garcia-Prieto JF, Gonzalez A, Ugo F, Cerrato E, Bondia E, Raposeiras-Roubin S, Mendez JLJ, Espejo C, Lopez-Masjuan A, Marin F, Lopez-Pais J, Abumayyaleh M, Corbi-Pascual M, Liebetrau C, Ramakrishna H, Estrada V, Macaya C, Fernandez-Ortiz A; HOPE COVID-19 Investigators (Cols Appendix). Renin-angiotensin system inhibitors effect before and during hospitalization in COVID-19 outcomes: Final analysis of the international HOPE COVID-19 (Health Outcome Predictive Evaluation for COVID-19) registry. Am Heart J. 2021 Jul;237:104-115. doi: 10.1016/j.ahj.2021.04.001. Epub 2021 Apr 15.
PubMed 33845032Porta-Etessam J, Nunez-Gil IJ, Gonzalez Garcia N, Fernandez-Perez C, Viana-Llamas MC, Eid CM, Romero R, Molina M, Uribarri A, Becerra-Munoz VM, Aguado MG, Huang J, Rondano E, Cerrato E, Alfonso E, Mejia AFC, Marin F, Roubin SR, Pepe M, Feltes G, Mate P, Cortese B, Buzon L, Mendez JJ, Estrada V. COVID-19 anosmia and gustatory symptoms as a prognosis factor: a subanalysis of the HOPE COVID-19 (Health Outcome Predictive Evaluation for COVID-19) registry. Infection. 2021 Aug;49(4):677-684. doi: 10.1007/s15010-021-01587-9. Epub 2021 Mar 1.
PubMed 33646505
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International COVID19 Clinical Evaluation Registry: HOPECOVID19. (Health Outcome Predictive Evaluation for COVID19)
- ClinicalTrials.gov ID
- NCT04334291
- Acronym / sponsor ID
- HOPE COVID 19 / 20/241-E
- Conditions
- COVID 19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,168 participants (actual)
- Lead sponsor
- IVAN J NUÑEZ GILUniversity, hospital or other
- Study start
- 23 Mar 2020 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Weeks
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Confirmed diagnosis or a COVID-19 high suspicion.
Key inclusion criteria (1 listed)
- Patients discharged (deceased or alive) from any hospital center with a confirmed diagnosis or a COVID-19 high suspicion.
Key exclusion criteria (1 listed)
- There are no exclusion criteria, except for the patient's explicit refusal to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational (registry)Observational study. | Combination product | – |
Primary outcome
Death
Time frame: through study completion, an average of 1 month
All cause
10 secondary outcomes
In hospital stay.
Time frame: through study completion, an average of 1 month
Heart failure
Time frame: through study completion, an average of 1 month
Renal failure
Time frame: through study completion, an average of 1 month
Respiratory Insufficiency.
Time frame: through study completion, an average of 1 month
Upper respiratory tract involvement
Time frame: through study completion, an average of 1 month
Pneumonia
Time frame: through study completion, an average of 1 month
Sepsis
Time frame: through study completion, an average of 1 month
Systemic inflammatory response Syndrome.
Time frame: through study completion, an average of 1 month
Clinically relevant bleeding
Time frame: through study completion, an average of 1 month
Other complications.
Time frame: through study completion, an average of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Background: PubMed 32989425Nunez-Gil IJ, Estrada V, Fernandez-Perez C, Feltes G, Vedia O, Vergara-Uzcategui CE, Moreno-Menguia VH, Cerrato E, D'Ascenzo F, Raposeiras-Roubin S, Martin-Sanchez FJ, Alfonso-Rodriguez E, Huang J, Ramakrishna H, Gil-Higes E, Fernandez-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.
- Background: PubMed 33583755Uribarri A, Nunez-Gil IJ, Aparisi A, Arroyo-Espliguero R, Maroun Eid C, Romero R, Becerra-Munoz VM, Feltes G, Molina M, Garcia-Aguado M, Cerrato E, Capel-Astrua T, Alfonso-Rodriguez E, Castro-Mejia AF, Raposeiras-Roubin S, Espejo C, Perez-Sole N, Bardaji A, Marin F, Fabregat-Andres O, D'ascenzo F, Santoro F, Akin I, Estrada V, Fernandez-Ortiz A, Macaya C; HOPE COVID-19 investigators. Atrial fibrillation in patients with COVID-19. Usefulness of the CHA2DS2-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.
- Background: PubMed 33555436Pepe M, Maroun-Eid C, Romero R, Arroyo-Espliguero R, Fernandez-Rozas I, Aparisi A, Becerra-Munoz VM, Garcia Aguado M, Brindicci G, Huang J, Alfonso-Rodriguez E, Castro-Mejia AF, Favretto S, Cerrato E, Albiol P, Raposeiras-Roubin S, Vedia O, Feltes Guzman G, Carrero-Fernandez A, Perez Cimarra C, Buzon L, Jativa Mendez JL, Abumayyaleh M, Corbi-Pascual M, Macaya C, Estrada V, Nestola PL, Biondi-Zoccai G, Nunez-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.
- Results publication: PubMed 33080051Rivera-Caravaca JM, Nunez-Gil IJ, Vivas D, Viana-Llamas MC, Uribarri A, Becerra-Munoz VM, Trabattoni D, Fernandez Rozas I, Feltes G, Lopez-Pais J, El-Battrawy I, Macaya C, Fernandez-Ortiz A, Estrada V, Marin F; HOPE COVID-19 Investigators. Clinical profile and prognosis in patients on oral anticoagulation before admission for COVID-19. Eur J Clin Invest. 2021 Jan;51(1):e13436. doi: 10.1111/eci.13436. Epub 2020 Nov 7.
- Results publication: PubMed 33165755Nunez-Gil IJ, Fernandez-Perez C, Estrada V, Becerra-Munoz VM, El-Battrawy I, Uribarri A, Fernandez-Rozas I, Feltes G, Viana-Llamas MC, Trabattoni D, Lopez-Pais J, Pepe M, Romero R, Castro-Mejia AF, Cerrato E, Astrua TC, D'Ascenzo F, Fabregat-Andres O, Moreu J, Guerra F, Signes-Costa J, Marin F, Buosenso D, Bardaji A, Raposeiras-Roubin S, Elola J, Molino A, Gomez-Doblas JJ, Abumayyaleh M, Aparisi A, Molina M, Guerri A, Arroyo-Espliguero R, Assanelli E, Mapelli M, Garcia-Acuna JM, Brindicci G, Manzone E, Ortega-Armas ME, Bianco M, Trung CP, Nunez MJ, Castellanos-Lluch C, Garcia-Vazquez E, Cabello-Clotet N, Jamhour-Chelh K, Tellez MJ, Fernandez-Ortiz A, Macaya C; HOPE COVID-19 Investigators. Mortality risk assessment in Spain and Italy, insights of the HOPE COVID-19 registry. Intern Emerg Med. 2021 Jun;16(4):957-966. doi: 10.1007/s11739-020-02543-5. Epub 2020 Nov 9.
- Results publication: PubMed 32692012Nunez-Gil IJ, Estrada V, Fernandez-Perez C, Fernandez-Rozas I, Martin-Sanchez FJ, Macaya C. The COVID-19 curve, health system overload, and mortality. Emergencias. 2020 Ago;32(4):293-295. No abstract available. English, Spanish.
- Results publication: PubMed 32602006Uribarri A, Nunez-Gil IJ, Aparisi A, Becerra-Munoz VM, Feltes G, Trabattoni D, Fernandez-Rozas I, Viana-Llamas MC, Pepe M, Cerrato E, Capel-Astrua T, Romero R, Castro-Mejia AF, El-Battrawy I, Lopez-Pais J, D'Ascenzo F, Fabregat-Andres O, Bardaji A, Raposeiras-Roubin S, Marin F, Fernandez-Ortiz A, Macaya C, Estrada V; HOPE COVID-19 Investigators. Impact of renal function on admission in COVID-19 patients: an analysis of the international HOPE COVID-19 (Health Outcome Predictive Evaluation for COVID 19) Registry. J Nephrol. 2020 Aug;33(4):737-745. doi: 10.1007/s40620-020-00790-5. Epub 2020 Jun 29.
- Results publication: PubMed 33346365Nunez-Gil IJ, Fernandez-Ortiz A, Maroud Eid C, Huang J, Romero R, Becerra-Munoz 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-Mejia AF, Raposeiras-Roubin S, D'Ascenzo F, Espejo Paeres C, Signes-Costa J, Bardaji A, Fernandez-Perez C, Marin F, Fabregat-Andres O, Akin I, Estrada V, Macaya C. Underlying heart diseases and acute COVID-19 outcomes. Cardiol J. 2021;28(2):202-214. doi: 10.5603/CJ.a2020.0183. Epub 2020 Dec 21.
- Results publication: PubMed 33201181Becerra-Munoz VM, Nunez-Gil IJ, Eid CM, Garcia Aguado M, Romero R, Huang J, Mulet A, Ugo F, Rametta F, Liebetrau C, Aparisi A, Fernandez-Rozas I, Viana-Llamas MC, Feltes G, Pepe M, Moreno-Rondon LA, Cerrato E, Raposeiras-Roubin S, Alfonso E, Carrero-Fernandez A, Buzon-Martin L, Abumayyaleh M, Gonzalez A, Fernandez Ortiz A, Macaya C, Estrada V, Fernandez-Perez C, Gomez-Doblas JJ. Clinical profile and predictors of in-hospital mortality among older patients hospitalised for COVID-19. Age Ageing. 2021 Feb 26;50(2):326-334. doi: 10.1093/ageing/afaa258.
- Results publication: PubMed 33329400Ruiz-Sanchez JG, Nunez-Gil IJ, Cuesta M, Rubio MA, Maroun-Eid C, Arroyo-Espliguero R, Romero R, Becerra-Munoz VM, Uribarri A, Feltes G, Trabattoni D, Molina M, Garcia Aguado M, Pepe M, Cerrato E, Alfonso E, Castro Mejia AF, Roubin SR, Buzon L, Bondia E, Marin F, Lopez Pais J, Abumayyaleh M, D'Ascenzo F, Rondano E, Huang J, Fernandez-Perez C, Macaya C, de Miguel Novoa P, Calle-Pascual AL, Estrada Perez V, Runkle I; HOPE COVID-19 investigators. Prognostic Impact of Hyponatremia and Hypernatremia in COVID-19 Pneumonia. A HOPE-COVID-19 (Health Outcome Predictive Evaluation for COVID-19) Registry Analysis. Front Endocrinol (Lausanne). 2020 Nov 30;11:599255. doi: 10.3389/fendo.2020.599255. eCollection 2020.
- Results publication: PubMed 34409593El-Battrawy I, Nunez-Gil IJ, Abumayyaleh M, Estrada V, Manuel Becerra-Munoz V, Uribarri A, Fernandez-Rozas I, Feltes G, Arroyo-Espliguero R, Trabattoni D, Lopez-Pais J, Pepe M, Romero R, Castro-Mejia AF, Cerrato E, Capel Astrua T, D'Ascenzo F, Fabregat-Andres O, Signes-Costa J, Marin F, Buonsenso D, Bardaji A, Jesus Tellez M, Fernandez-Ortiz A, Macaya C, Akin I. COVID-19 and the impact of arterial hypertension-An analysis of the international HOPE COVID-19 Registry (Italy-Spain-Germany). Eur J Clin Invest. 2021 Nov;51(11):e13582. doi: 10.1111/eci.13582. Epub 2021 Aug 19.
- Results publication: PubMed 34629634Signes-Costa J, Nunez-Gil IJ, Soriano JB, Arroyo-Espliguero R, Eid CM, Romero R, Uribarri A, Fernandez-Rozas I, Aguado MG, Becerra-Munoz VM, Huang J, Pepe M, Cerrato E, Raposeiras S, Gonzalez A, Franco-Leon F, Wang L, Alfonso E, Ugo F, Garcia-Prieto JF, Feltes G, Abumayyaleh M, Espejo-Paeres C, Jativa J, Masjuan AL, Macaya C, Carbonell Asins JA, Estrada V; HOPE COVID-19 investigators. Prevalence and 30-Day Mortality in Hospitalized Patients With Covid-19 and Prior Lung Diseases. Arch Bronconeumol. 2021 Apr;57:13-20. doi: 10.1016/j.arbres.2020.11.012. Epub 2020 Dec 16.
- Individual participant dataSharing planned: No. IPD are to be share among HOPE researchers. However, the HOPE Steering committee is open to collaborative proposals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID 19, run by IVAN J NUÑEZ GIL at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: through study completion, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04334291, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.