NCT04948242

Brief Summary

A multicenter observational, prospective cohort study that consisted of a large-scale data source of hospital ICU admissions and patient-level clinical data in Spain. The main objective is to develop a national database belonging to SEMICYUC (Spanish Society of Critical Care) to describe epidemiological and clinical characteristics and risk factors related to ICU mortality in critically ill patients admitted to ICU due to severe COVID-19 in Spain.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 20, 2023

Status Verified

April 1, 2023

Enrollment Period

3.3 years

First QC Date

June 29, 2021

Last Update Submit

April 17, 2023

Conditions

SARS-CoV2 Infection

Keywords

COVID-19Severe SARS-CoV-2 infectionCritically ill patientsADRSViral pneumonia

Outcome Measures

Primary Outcomes (1)

  • Epidemiologic and Clinical Characteristics and risk factors for ICU mortality in critically ill patients with COVID-19 in Spain

    To determine demographics and clinical factors associated with ICU mortality at days-28 and ICU discharge

    Observational period from ICU admission to data of discharge alive or date of death from any cause at days 28 of ICU length of stay and ICU discharge

Secondary Outcomes (2)

  • Support respiratory type and prognosis

    Observational period from ICU admission to data of discharge alive or date of death from any cause at days 28 of ICU length of stay and ICU discharge

  • Comorbidities and prognosis

    Observational period from ICU admission to data of discharge alive or date of death from any cause at days 28 of ICU length of stay and ICU discharge

Study Arms (1)

Consecutive critically ill patients admitted to ICU with severe SARS-CoV-2 infection

Consecutive adult patients (\> 16 years) with laboratory confirmed SARS-CoV-2 infection, detected by RT-PCR positive test of nasopharyngeal, oropharyngeal , swab or invasive respiratory samples according to the WHO recommendations. The follow-up of patients was to ICU discharge or death whichever occurred first. No interventions will be made. Only anonymized demographic data, clinical data, laboratory data and ventilatory support data will be collected. There is no standardized pharmacological treatment protocol. Only basic data are collected about the different treatments administered by the attending physician.

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critically ill patients with community-acquired pneumonia due to SARS-CoV-2 infection

You may qualify if:

  • Severe community-acquired pneumonia due SARS CoV-2 infection and acute respiratory failure with microbiological confirmation (RT-PCR) according international guidelines
  • Age \>= 16 years without upper limit

You may not qualify if:

  • Age \< 16 years
  • Patients with SARS-CoV-2 infection without acute respiratory failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de Tarragona Joan XXIII

Tarragona, 43007, Spain

RECRUITING

Related Publications (4)

  • Berenguer J, Ryan P, Rodriguez-Bano J, Jarrin I, Carratala J, Pachon J, Yllescas M, Arriba JR; COVID-19@Spain Study Group; Fundacion SEIMC-GESIDA; Hospital General Universitario Gregorio Maranon; Hospital Universitario La Paz; Hospital Infanta Leonor; Complejo Hospitalario Virgen de la Salud; Hospital Universitario Rafael Mendez; Hospital Universitario de Cruces; Hospital de Melilla; Hospital San Eloy de Barakaldo; Hospital Universitario Central de Asturias; Hospital General Universitario de Alicante; Hospital Virgen de la Victoria; Hospital Universitario Puerto Real; EOXI Pontevedra e Salnes; Hospital de Figueres; Hospital Sant Jaume de Calella; Hospital del Mar; Hospital Virgen de la Arrixaca; Hospital de Can Misses; Hospital de Sagunto; Hospital Clinico San Cecilio; Hospital Universitario Principe de Asturias; Parc Sanitari Sant Joan de Deu; Hospital Nuestra Senora de Gracia; HC Marbella Internacional Hospital; Hospital La Princesa; Hospital Josep Trueta; Hospital Dos de Maig; Hospital Arnau de Vilanova-Lliria; Hospital General Universitario de Elche; Hospital Clinico Universitario de Valencia; Complejo Asistencial de Avila; Hospital Comarcal de Alcaniz; Hospital Universitario Marques de Valdecilla; Hospital Quiron-Salud de Torrevieja; Hospital Universitario Miguel Servet; SCIAS, Hospital de Barcelona; Fundacion Hospital Universitario Alcorcon; Hospital Alvaro Cunqueiro; Complejo Asistencial Universitario de Salamanca; Hospital Universitario Severo Ochoa; Hospital CIMA-Sanitas; Hospital HLA Inmaculada; Hospital Universitario Rio Hortega; Hospital de Guadalajara; Hospital Universitario Infanta Sofia; Hospital Comarcal de Blanes; Hospital Universitari de Tarragona Joan XXIII; Hospital Universitario Basurto; Hospital Universitario de Canarias; Hospital Universitario de Gran Canaria Dr Negrin; Hospital Son Espases; Hospital Universitario de Mostoles; Complejo Hospitalario Universitario A Coruna; Hospital Costa del Sol; Hospital Clinico Universitario Lozano Blesa; Hospital Mutua de Terrassa; Hospital de la Plana; Hospital Virgen de la Concha-Complejo Asistencial de Zamora; Complejo Hospitalario Universitario Insular Materno-Infantil; Hospital de la Marina Baixa; Hospital Universitario Virgen Macarena; Hospital Universitari de Bellvitge; Hospital Universitario y Politecnico la Fe; Hospital Universitario del Vinalopo; Hospital de Sabadell (Parc Tauli); Hospital Clinic de Barcelona; Hospital Universitario de la Ribera; Fundacion Jimenez Diaz; Hospital Clinico Universitario de Valladolid; Hospital Clinico San Carlos; Hospital Santa Creu i Sant Pau; Clinica Universitaria de Navarra-Campus Madrid; Hospital Son Llatzer; Hospital General de la Defensa Gomez Ulla; Hospital Universitario de Alava; Hospital Santos Reyes; Hospital Dr Jose Molina Orosa; Hospital Vall d'Hebron; Hospital Universitario Rey Juan Carlos; Complejo Hospitalario Universitario Santa Lucia; Hospital Santa Barbara; Complejo Hospitalario Universitario de Ferrol; Hospital de l'Esperit Sant; Hospital Universitario los Arcos del Mar Menor; Hospital HLA Universitario Moncloa; Hospital Virgen del Puerto; Hospital Marina Salud de Denia; Hospital Universitario de Jerez; Hospital Reina Sofia de Tudela; Hospital Clinico Universitario de Santiago de Compostela; Hospital Universitario del Henares; Hospital Universitario Lucus Augusti; Hospital de Donostia; Hospital de Urduliz Alfredo Espinosa; Hospital de Mendaro; Hospital Juan Ramon Jimenez; Hospital de Tortosa Virgen de la Cinta; Hospital Riotinto; Hospital Vega Baja; Hospital Puerta de Hierro; Hospital Universitario de Getafe; Hospital General de la Palma; Hospital El Bierzo; Fundacion Hospital de Calahorra; Hospital Alto Deba; Hospital Universitario San Juan de Alicante; Hospital de Guadarrama; Hospital Universitario de Jaen; Hospital de Mataro; Hospital de Palamos; Hospital Universitario de Valme; Clinica Universitaria de Navarra-Campus Navarra; Hospital Clinica Benidorm; Hospital Doce de Octubre; Hospital Universitario Virgen del Rocio; Hospital Universitario Ramon y Cajal; Hospital Universitario San Pedro; Hospital Quiron A Coruna; HM Sanchinarro; Hospital Francesc de Borja; Complejo Hospitalario Universitario Nuestra Senora de La Candelaria; Hospital Universitario HM Monteprincipe; Hospital Universitario HM Puerta del Sur; Hospital Universitario HM Torrelodones; Hospital Universitario HM Madrid; Hospital Don Benito-Villanueva de la Serena; Hospital de Viladecans; Centro Nacional de Epidemiologia. Characteristics and predictors of death among 4035 consecutively hospitalized patients with COVID-19 in Spain. Clin Microbiol Infect. 2020 Nov;26(11):1525-1536. doi: 10.1016/j.cmi.2020.07.024. Epub 2020 Aug 4.

    PMID: 32758659BACKGROUND

  • Berenguer J, Borobia AM, Ryan P, Rodriguez-Bano J, Bellon JM, Jarrin I, Carratala J, Pachon J, Carcas AJ, Yllescas M, Arribas JR; COVID-19@Spain and COVID@HULP Study Groups. Development and validation of a prediction model for 30-day mortality in hospitalised patients with COVID-19: the COVID-19 SEIMC score. Thorax. 2021 Sep;76(9):920-929. doi: 10.1136/thoraxjnl-2020-216001. Epub 2021 Feb 25.

    PMID: 33632764BACKGROUND

  • Rodriguez A, Ruiz-Botella M, Martin-Loeches I, Jimenez Herrera M, Sole-Violan J, Gomez J, Bodi M, Trefler S, Papiol E, Diaz E, Suberviola B, Vallverdu M, Mayor-Vazquez E, Albaya Moreno A, Canabal Berlanga A, Sanchez M, Del Valle Ortiz M, Ballesteros JC, Martin Iglesias L, Marin-Corral J, Lopez Ramos E, Hidalgo Valverde V, Vidaur Tello LV, Sancho Chinesta S, Gonzales de Molina FJ, Herrero Garcia S, Sena Perez CC, Pozo Laderas JC, Rodriguez Garcia R, Estella A, Ferrer R; COVID-19 SEMICYUC Working Group. Deploying unsupervised clustering analysis to derive clinical phenotypes and risk factors associated with mortality risk in 2022 critically ill patients with COVID-19 in Spain. Crit Care. 2021 Feb 15;25(1):63. doi: 10.1186/s13054-021-03487-8.

    PMID: 33588914RESULT

  • Manrique S, Claverias L, Magret M, Masclans JR, Bodi M, Trefler S, Canadell L, Diaz E, Sole-Violan J, Bisbal-Andres E, Natera RG, Moreno AA, Vallverdu M, Ballesteros JC, Socias L, Vidal FG, Sancho S, Martin-Loeches I, Rodriguez A. Timing of intubation and ICU mortality in COVID-19 patients: a retrospective analysis of 4198 critically ill patients during the first and second waves. BMC Anesthesiol. 2023 Apr 27;23(1):140. doi: 10.1186/s12871-023-02081-5.

    PMID: 37106321DERIVED

Related Links

MeSH Terms

Conditions

COVID-19Pneumonia, Viral

Condition Hierarchy (Ancestors)

PneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Alejandro Rodriguez Oviedo, MD,PhD,MsC

    Hospital Universitari de Tarragona Joan XXIII

    STUDY DIRECTOR

Central Study Contacts

Alejandro Rodríguez Oviedo, MD,PhD,MsC

CONTACT

+34977295818ahr1161@yahoo.es

Sandra Trefler Crespo, BsC,PhD

CONTACT

+34977295818sitrefler@yahoo.es

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD,MsC

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 1, 2021

Study Start

December 12, 2019

Primary Completion

April 17, 2023

Study Completion

December 31, 2023

Last Updated

April 20, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)