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COVID19@Spain: Characteristics and Outcomes of Hospitalized Patients With COVID-19 in Spain

Sponsor
Fundacion SEIMC-GESIDA (Other)
Overall Status
Completed
CT.gov ID
NCT04355871
Collaborator
(none)
4,035
Enrollment
128
Locations
30
Actual Duration (Days)
31.5
Patients Per Site
32
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

COVID-19@Spain is a retrospective cohort study that aims to determine the clinical characteristics of hospitalized patients with COVID-19 in Spain and to identify prognostic factors of mortality and the need for mechanical ventilation

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    COVID-19@Spain is a retrospective cohort study of patients admitted to Spanish hospitals with laboratory-confirmed COVID-19 infection by real-time polymerase chain reaction (RT-PCR) assay for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

    The Ethics Committee for Research with Medicines of Hospital General Universitario Gregorio Marañón approved the study and waived informed consent for the collection of clinical data.

    Investigators from participating centers were asked to include the first consecutive hospitalized patients (up to 100) meeting the study criteria from the start of the epidemic until March 17, 2020.

    The data source was the electronic medical records. All data were entered directly by personnel at each institution using an online case report form (CRF), that satisfied local requirements of data confidentiality.

    The variables registered included administrative data, epidemiological information, type of clinical specimen in which the diagnosis was confirmed, and the RT-PCR cycle threshold (Ct) of the confirmatory gene. We also registered demographics, comorbidities and current medications, signs and symptoms at admission, baseline laboratory tests results, chest X-ray findings at baseline and during follow-up, complications during hospitalization, medications with potential activity against COVID-19, and supportive treatments including oxygen therapy, admission to intensive care unit (ICU), mechanical ventilation (intubation), and use of adjuvant anti-inflammatory medications such as tocilizumab and systemic corticosteroids. Drug-related adverse events of medications for COVID-19 needing discontinuation were also recorded. The clinical status of the patients as of April 17, 2020, was categorized as discharged alive (with the date of discharge), alive and currently hospitalized, and death (with the date of death).

    The primary endpoint is all-cause mortality at day 28, and the secondary endpoint is the need for mechanical ventilation. Baseline was the date of hospital admission. The follow-up censoring date is April 17, 2020.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    4035 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Characteristics and Predictors of Death Among Hospitalized Patients With COVID-19 in Spain
    Actual Study Start Date :
    Mar 18, 2020
    Actual Primary Completion Date :
    Apr 15, 2020
    Actual Study Completion Date :
    Apr 17, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Overall mortality [28 days]

    Secondary Outcome Measures

    1. Mechanical ventilation [28 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Laboratory-confirmed COVID-19 infection by real-time polymerase chain reaction (RT-PCR) assay

    • Hospital admission

    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Comp. Hosp. Univ. A Coruña A Coruña Spain
    2 H. Quiron A Coruña A Coruña Spain
    3 H. de Alcaniz Alcañiz Spain
    4 H. Gral Univ. de Alicante Alicante Spain
    5 H. Univ. San Juan de Alicante Alicante Spain
    6 H. Univ. de la Ribera Alzira Spain
    7 H. Santos Reyes Aranda De Duero Spain
    8 H. Dr. Jose Molina Orosa Arrecife Spain
    9 Consorcio Sanitari Integral (CAIDM) Barcelona Spain
    10 H. Clinic Barcelona Spain
    11 H. del Mar Barcelona Spain
    12 H. Parc Sanitari Sant Joan de Deu Barcelona Spain
    13 H. Santa Creu y Sant Pau Barcelona Spain
    14 H. Univ. de Bellvitge Barcelona Spain
    15 H. Vall d'Hebron Barcelona Spain
    16 Hospital CIMA-Sanitas Barcelona Spain
    17 SCIAS H. de Barcelona Barcelona Spain
    18 H. Clinica de Benidorm Benidorm Spain
    19 H. de Cruces Bilbao Spain
    20 H. San Eloy_Barakaldo Bilbao Spain
    21 H. Univ. de Basurto Bilbao Spain
    22 H. Urduliz-Alfredo Espinosa Bilbao Spain
    23 H. Gral de La Palma Breña Alta Spain
    24 H. de Puerto Real Cadiz Spain
    25 H. de Calahorra Calahorra Spain
    26 H. Sant Jaume de Calella Calella Spain
    27 H. Univ Santa Lucia Cartagena Spain
    28 H. Univ de Henares Coslada Spain
    29 Hospital Marina Salud de Dénia Denia Spain
    30 Hospital Don Benito-Villanueva de la Serena Don Benito Spain
    31 H. Gral Univ. de Elche Elche Spain
    32 H. Univ. del Vinalopo Elche Spain
    33 Comp. Hospt. Univ. de Ferrol Ferrol Spain
    34 H. Francesc de Borja Gandia Spain
    35 H. de Figueres Gerona Spain
    36 H. Comarcal de Blanes Girona Spain
    37 H. Josep Trueta Girona Spain
    38 H. Clinico San Cecilio Granada Spain
    39 Hospital HLA Inmaculada Granada Spain
    40 H. de Guadalajara Guadalajara Spain
    41 H. de Guadarrama Guadarrama Spain
    42 H. Juan Ramón Jiménez Huelva Spain
    43 H. Riotinto Huelva Spain
    44 H. Can Misses Ibiza Spain
    45 H. Universitario de Jaén Jaén Spain
    46 H. Univ. de Jerez de la Frontera Jerez De La Frontera Spain
    47 H. Univ Insular de Gran Canaria Las Palmas De Gran Canaria Spain
    48 H. Universitario de Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
    49 H. Univ. Severo Ochoa Leganés Spain
    50 H. San Pedro Logroño Spain
    51 H. Univ. Menez Rafael Mendez Lorca Spain
    52 H. Lucus Augusti Lugo Spain
    53 H. 12 de Octubre Madrid Spain
    54 H. Clinica Univ. de Navarra_ Campus Madrid Madrid Spain
    55 H. Clinico San Carlos Madrid Spain
    56 H. Fundacion Jiménez Díaz Madrid Spain
    57 H. Gral de la Defensa Gomez Ulla Madrid Spain
    58 H. HLA Univ. Moncloa Madrid Spain
    59 H. HM Sanchinarro Madrid Spain
    60 H. Puerta de Hierro Madrid Spain
    61 H. Univ HM Madrid Madrid Spain
    62 H. Univ Principe de Asturias Madrid Spain
    63 H. Univ. de Alcorcón Madrid Spain
    64 H. Univ. de Getafe Madrid Spain
    65 H. Univ. de Móstoles Madrid Spain
    66 H. Univ. Gregorio Marañon Madrid Spain
    67 H. Univ. HM Monteprincipe Madrid Spain
    68 H. UNiv. HM Puerta del Sur Madrid Spain
    69 H. Univ. Infanta Leonor Madrid Spain
    70 H. Univ. La Paz Madrid Spain
    71 H. Univ. La Princesa Madrid Spain
    72 H. Univ. Ramón y Cajal Madrid Spain
    73 H. Univ. Rey Juan Carlos Madrid Spain
    74 H. Costa del Sol Marbella Spain
    75 H. de Mataro Mataró Spain
    76 H. de Melilla Melilla Spain
    77 H. de Mendaro Mendaro Spain
    78 Hospital Alto Deba Mondragón Spain
    79 H. Virgen de la Arrixaca Murcia Spain
    80 H. Marbella Internacional Málaga Spain
    81 H. Virgen de la Victoria Málaga Spain
    82 H. Vega Baja Orihuela Spain
    83 H. Univ. Central de Asturias Oviedo Spain
    84 H. de Palamos Palamós Spain
    85 H. Son Espases Palma De Mallorca Spain
    86 H. Son Llatzer Palma De Mallorca Spain
    87 H. Clinica Univ. Navarra Pamplona Spain
    88 H. Virgen del Puerto Plasencia Spain
    89 H. El Bierzo Ponferrada Spain
    90 H. Do Salnes Pontevedra Spain
    91 H. UNiv. Los Arcos del Mar Menor Pozo Aledo Spain
    92 H. Santa Barbara Puertollano Spain
    93 H. Parc Tauli Sabadell Spain
    94 Complejo Asist. Univ. de Salamanca Salamanca Spain
    95 H. Infanta Sofia San Sebastián De Los Reyes Spain
    96 H. de Donostia San Sebastián Spain
    97 H. de l'Esperit Sant Santa Coloma De Gramenet Spain
    98 H. Univ. Marques de Valdecilla Santander Spain
    99 H. Clinico Univ. Santiago de Compostela Santiago De Compostela Spain
    100 H. Univ de Valme Sevilla Spain
    101 H. Univ. Virgen del Rocio Sevilla Spain
    102 H. Univ. Virgen Macarena Sevilla Spain
    103 H. Virgen Macarena Sevilla Spain
    104 H. Univ Joan XXIII Tarragona Spain
    105 H. U. de Canarias Tenerife Spain
    106 H. Univ. Nuestra Sra. de la Candelaria Tenerife Spain
    107 H. Mutua de Terrasa Terrassa Spain
    108 Complejo Hospitalario Virgen de la Salud Toledo Spain
    109 H. Univ. HM Torrelodones Torrelodones Spain
    110 H. Quiron Salud Torrevieja Torrevieja Spain
    111 H. Virgen de la Cinta Tortosa Spain
    112 H. Reina Sofia de Tudela Tudela Spain
    113 H. Arnau de Vilanova-Lliria Valencia Spain
    114 H. Clinico Univ. de Valencia Valencia Spain
    115 H. de Sagunto Valencia Spain
    116 H. Univ. y Polit. La Fe Valencia Spain
    117 H. Clin. Univ. de Valladolid Valladolid Spain
    118 H. Rio Hortega Valladolid Spain
    119 H. Alvaro Cunqueiro Vigo Spain
    120 H. de Viladecans Viladecans Spain
    121 H. de la Marina Baixa Villajoyosa Spain
    122 Hospital de la Plana Villareal Spain
    123 H. Univ de Alava Vitoria Spain
    124 H. Virgen de la Concha Zamora Spain
    125 H. Lozano Blesa Zaragoza Spain
    126 H. Miguel Servet Zaragoza Spain
    127 H. Ntra. Sra. de Gracia Zaragoza Spain
    128 Complejo Asistencial de Avila Ávila Spain

    Sponsors and Collaborators

    • Fundacion SEIMC-GESIDA

    Investigators

    • Principal Investigator: Jose Ramón Arribas, MD, H. Univ. La Paz
    • Principal Investigator: Juan Berenguer, MD, H. Univ. Gregorio Marañón
    • Principal Investigator: Pablo Ryan, MD, H. Univ. Infanta Leonor
    • Principal Investigator: Jesús Rodriguez Baños, MD, H. Univ. Virgen Macarena
    • Principal Investigator: Jordi Carratala, MD, H. Univ. de Bellvitge
    • Principal Investigator: Jerónimo Pachón, MD, H. Univ. VIrgen del Rocio

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fundacion SEIMC-GESIDA
    ClinicalTrials.gov Identifier:
    NCT04355871
    Other Study ID Numbers:
    • COVID-19/SEIMC-FSG
    First Posted:
    Apr 21, 2020
    Last Update Posted:
    May 11, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fundacion SEIMC-GESIDA
    Covid19
    SARS-CoV-2
    Coronavirus
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of May 11, 2020