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 DiseaseIntervention/TreatmentPhase

    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

    SiteCityStateCountryPostal Code
    1Comp. Hosp. Univ. A CoruñaA CoruñaSpain
    2H. Quiron A CoruñaA CoruñaSpain
    3H. de AlcanizAlcañizSpain
    4H. Gral Univ. de AlicanteAlicanteSpain
    5H. Univ. San Juan de AlicanteAlicanteSpain
    6H. Univ. de la RiberaAlziraSpain
    7H. Santos ReyesAranda De DueroSpain
    8H. Dr. Jose Molina OrosaArrecifeSpain
    9Consorcio Sanitari Integral (CAIDM)BarcelonaSpain
    10H. ClinicBarcelonaSpain
    11H. del MarBarcelonaSpain
    12H. Parc Sanitari Sant Joan de DeuBarcelonaSpain
    13H. Santa Creu y Sant PauBarcelonaSpain
    14H. Univ. de BellvitgeBarcelonaSpain
    15H. Vall d'HebronBarcelonaSpain
    16Hospital CIMA-SanitasBarcelonaSpain
    17SCIAS H. de BarcelonaBarcelonaSpain
    18H. Clinica de BenidormBenidormSpain
    19H. de CrucesBilbaoSpain
    20H. San Eloy_BarakaldoBilbaoSpain
    21H. Univ. de BasurtoBilbaoSpain
    22H. Urduliz-Alfredo EspinosaBilbaoSpain
    23H. Gral de La PalmaBreña AltaSpain
    24H. de Puerto RealCadizSpain
    25H. de CalahorraCalahorraSpain
    26H. Sant Jaume de CalellaCalellaSpain
    27H. Univ Santa LuciaCartagenaSpain
    28H. Univ de HenaresCosladaSpain
    29Hospital Marina Salud de DéniaDeniaSpain
    30Hospital Don Benito-Villanueva de la SerenaDon BenitoSpain
    31H. Gral Univ. de ElcheElcheSpain
    32H. Univ. del VinalopoElcheSpain
    33Comp. Hospt. Univ. de FerrolFerrolSpain
    34H. Francesc de BorjaGandiaSpain
    35H. de FigueresGeronaSpain
    36H. Comarcal de BlanesGironaSpain
    37H. Josep TruetaGironaSpain
    38H. Clinico San CecilioGranadaSpain
    39Hospital HLA InmaculadaGranadaSpain
    40H. de GuadalajaraGuadalajaraSpain
    41H. de GuadarramaGuadarramaSpain
    42H. Juan Ramón JiménezHuelvaSpain
    43H. RiotintoHuelvaSpain
    44H. Can MissesIbizaSpain
    45H. Universitario de JaénJaénSpain
    46H. Univ. de Jerez de la FronteraJerez De La FronteraSpain
    47H. Univ Insular de Gran CanariaLas Palmas De Gran CanariaSpain
    48H. Universitario de Gran Canaria Dr. NegrinLas Palmas De Gran CanariaSpain
    49H. Univ. Severo OchoaLeganésSpain
    50H. San PedroLogroñoSpain
    51H. Univ. Menez Rafael MendezLorcaSpain
    52H. Lucus AugustiLugoSpain
    53H. 12 de OctubreMadridSpain
    54H. Clinica Univ. de Navarra_ Campus MadridMadridSpain
    55H. Clinico San CarlosMadridSpain
    56H. Fundacion Jiménez DíazMadridSpain
    57H. Gral de la Defensa Gomez UllaMadridSpain
    58H. HLA Univ. MoncloaMadridSpain
    59H. HM SanchinarroMadridSpain
    60H. Puerta de HierroMadridSpain
    61H. Univ HM MadridMadridSpain
    62H. Univ Principe de AsturiasMadridSpain
    63H. Univ. de AlcorcónMadridSpain
    64H. Univ. de GetafeMadridSpain
    65H. Univ. de MóstolesMadridSpain
    66H. Univ. Gregorio MarañonMadridSpain
    67H. Univ. HM MonteprincipeMadridSpain
    68H. UNiv. HM Puerta del SurMadridSpain
    69H. Univ. Infanta LeonorMadridSpain
    70H. Univ. La PazMadridSpain
    71H. Univ. La PrincesaMadridSpain
    72H. Univ. Ramón y CajalMadridSpain
    73H. Univ. Rey Juan CarlosMadridSpain
    74H. Costa del SolMarbellaSpain
    75H. de MataroMataróSpain
    76H. de MelillaMelillaSpain
    77H. de MendaroMendaroSpain
    78Hospital Alto DebaMondragónSpain
    79H. Virgen de la ArrixacaMurciaSpain
    80H. Marbella InternacionalMálagaSpain
    81H. Virgen de la VictoriaMálagaSpain
    82H. Vega BajaOrihuelaSpain
    83H. Univ. Central de AsturiasOviedoSpain
    84H. de PalamosPalamósSpain
    85H. Son EspasesPalma De MallorcaSpain
    86H. Son LlatzerPalma De MallorcaSpain
    87H. Clinica Univ. NavarraPamplonaSpain
    88H. Virgen del PuertoPlasenciaSpain
    89H. El BierzoPonferradaSpain
    90H. Do SalnesPontevedraSpain
    91H. UNiv. Los Arcos del Mar MenorPozo AledoSpain
    92H. Santa BarbaraPuertollanoSpain
    93H. Parc TauliSabadellSpain
    94Complejo Asist. Univ. de SalamancaSalamancaSpain
    95H. Infanta SofiaSan Sebastián De Los ReyesSpain
    96H. de DonostiaSan SebastiánSpain
    97H. de l'Esperit SantSanta Coloma De GramenetSpain
    98H. Univ. Marques de ValdecillaSantanderSpain
    99H. Clinico Univ. Santiago de CompostelaSantiago De CompostelaSpain
    100H. Univ de ValmeSevillaSpain
    101H. Univ. Virgen del RocioSevillaSpain
    102H. Univ. Virgen MacarenaSevillaSpain
    103H. Virgen MacarenaSevillaSpain
    104H. Univ Joan XXIIITarragonaSpain
    105H. U. de CanariasTenerifeSpain
    106H. Univ. Nuestra Sra. de la CandelariaTenerifeSpain
    107H. Mutua de TerrasaTerrassaSpain
    108Complejo Hospitalario Virgen de la SaludToledoSpain
    109H. Univ. HM TorrelodonesTorrelodonesSpain
    110H. Quiron Salud TorreviejaTorreviejaSpain
    111H. Virgen de la CintaTortosaSpain
    112H. Reina Sofia de TudelaTudelaSpain
    113H. Arnau de Vilanova-LliriaValenciaSpain
    114H. Clinico Univ. de ValenciaValenciaSpain
    115H. de SaguntoValenciaSpain
    116H. Univ. y Polit. La FeValenciaSpain
    117H. Clin. Univ. de ValladolidValladolidSpain
    118H. Rio HortegaValladolidSpain
    119H. Alvaro CunqueiroVigoSpain
    120H. de ViladecansViladecansSpain
    121H. de la Marina BaixaVillajoyosaSpain
    122Hospital de la PlanaVillarealSpain
    123H. Univ de AlavaVitoriaSpain
    124H. Virgen de la ConchaZamoraSpain
    125H. Lozano BlesaZaragozaSpain
    126H. Miguel ServetZaragozaSpain
    127H. Ntra. Sra. de GraciaZaragozaSpain
    128Complejo Asistencial de AvilaÁvilaSpain

    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 11, 2020