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International COVID19 Clinical Evaluation Registry, (HOPE COVID 19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04334291
Recruitment Status : Completed
First Posted : April 6, 2020
Last Update Posted : January 25, 2022
Sponsor:
Information provided by (Responsible Party):
IVAN J NUÑEZ GIL, St Carlos Hospital, Madrid, Spain

Study Description
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Brief 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.


Condition or disease Intervention/treatment
COVID 19 Combination Product: Observational (registry)

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Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 8168 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Weeks
Official Title: International COVID19 Clinical Evaluation Registry: HOPECOVID19. (Health Outcome Predictive Evaluation for COVID19)
Actual Study Start Date : March 23, 2020
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Combination Product: Observational (registry)
    Observational study.

Outcome Measures
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Primary Outcome Measures :
  1. Death [ Time Frame: through study completion, an average of 1 month ]
    All cause


Secondary Outcome Measures :
  1. In hospital stay. [ Time Frame: through study completion, an average of 1 month ]
    Days

  2. Heart failure [ Time Frame: through study completion, an average of 1 month ]
    According the attending physician.

  3. Renal failure [ Time Frame: through study completion, an average of 1 month ]
    According the attending physician.

  4. Respiratory Insufficiency. [ Time Frame: through study completion, an average of 1 month ]
    According the attending physician.

  5. Upper respiratory tract involvement [ Time Frame: through study completion, an average of 1 month ]
    According the attending physician.

  6. Pneumonia [ Time Frame: through study completion, an average of 1 month ]
    According the attending physician.

  7. Sepsis [ Time Frame: through study completion, an average of 1 month ]
    According the attending physician.

  8. Systemic inflammatory response Syndrome. [ Time Frame: through study completion, an average of 1 month ]
    According the attending physician.

  9. Clinically relevant bleeding [ Time Frame: through study completion, an average of 1 month ]
    According the attending physician.

  10. Other complications. [ Time Frame: through study completion, an average of 1 month ]
    According the attending physician.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Confirmed diagnosis or a COVID-19 high suspicion.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04334291


Locations
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Spain
Hospital Lclinico San Carlos
Madrid, Spain, 28040
Sponsors and Collaborators
IVAN J NUÑEZ GIL
More Information
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Publications of Results:
Nunez-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.

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
El-Battrawy I, Longo F, Nunez Gil IJ, Abumayyaleh M, Gianesin B, Estrada V, Aparisi A, Arroyo-Espliguero R, Balocco M, Barella S, Beccaria A, Bonetti F, Casale M, De Michele E, Denotti AR, Fidone C, Fortini M, Gamberini MR, Graziadei G, Lisi R, Massa A, Marcon A, Rubinski B, Miano M, Motta I, Pinto VM, Piperno A, Mariani R, Putti MC, Quota A, Ribersani M, Marziali M, Roberti D, Rosso R, Tartaglione I, Vitucci A, Voi V, Zecca M, Romero R, Marouneld C, Fernandez-Rozas I, Espejo C, Marhaeni W, Garcia Aguado M, Cappellini MD, Perrotta S, De Franceschi L, Piga A, Forni GL, Akin I. Thalassaemia is paradoxically associated with a reduced risk of in-hospital complications and mortality in COVID-19: Data from an international registry. J Cell Mol Med. 2022 May;26(9):2520-2528. doi: 10.1111/jcmm.17026. Epub 2022 Mar 30.

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Responsible Party: IVAN J NUÑEZ GIL, Principal Investigator. Attending Physician. MD, PhD, FESC, St Carlos Hospital, Madrid, Spain
ClinicalTrials.gov Identifier: NCT04334291    
Other Study ID Numbers: 20/241-E
EUPAS34399 ( Other Identifier: EMA )
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: January 25, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD are to be share among HOPE researchers. However, the HOPE Steering committee is open to collaborative proposals.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases