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NCT04355871 Clinical Trial

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

Covid19 Clinical Trial

— COVID19@Spain  

Official title:
Characteristics and Predictors of Death Among Hospitalized Patients With COVID-19 in Spain

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04355871
Other study ID # COVID-19/SEIMC-FSG
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 18, 2020
Est. completion date April 17, 2020

Study information
Verified date April 2020
Source Fundacion SEIMC-GESIDA
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 4035
Est. completion date April 17, 2020
Est. primary completion date April 15, 2020
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Laboratory-confirmed COVID-19 infection by real-time polymerase chain reaction (RT-PCR) assay - Hospital admission Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Spain Comp. Hosp. Univ. A Coruña A Coruña
Spain H. Quiron A Coruña A Coruña
Spain H. de Alcaniz Alcañiz
Spain H. Gral Univ. de Alicante Alicante
Spain H. Univ. San Juan de Alicante Alicante
Spain H. Univ. de la Ribera Alzira
Spain H. Santos Reyes Aranda De Duero
Spain H. Dr. Jose Molina Orosa Arrecife
Spain Complejo Asistencial de Avila Ávila
Spain Consorcio Sanitari Integral (CAIDM) Barcelona
Spain H. Clinic Barcelona
Spain H. del Mar Barcelona
Spain H. Parc Sanitari Sant Joan de Deu Barcelona
Spain H. Santa Creu y Sant Pau Barcelona
Spain H. Univ. de Bellvitge Barcelona
Spain H. Vall d'Hebron Barcelona
Spain Hospital CIMA-Sanitas Barcelona
Spain SCIAS H. de Barcelona Barcelona
Spain H. Clinica de Benidorm Benidorm
Spain H. de Cruces Bilbao
Spain H. San Eloy_Barakaldo Bilbao
Spain H. Univ. de Basurto Bilbao
Spain H. Urduliz-Alfredo Espinosa Bilbao
Spain H. Gral de La Palma Breña Alta
Spain H. de Puerto Real Cadiz
Spain H. de Calahorra Calahorra
Spain H. Sant Jaume de Calella Calella
Spain H. Univ Santa Lucia Cartagena
Spain H. Univ de Henares Coslada
Spain Hospital Marina Salud de Dénia Denia
Spain Hospital Don Benito-Villanueva de la Serena Don Benito
Spain H. Gral Univ. de Elche Elche
Spain H. Univ. del Vinalopo Elche
Spain Comp. Hospt. Univ. de Ferrol Ferrol
Spain H. Francesc de Borja Gandia
Spain H. de Figueres Gerona
Spain H. Comarcal de Blanes Girona
Spain H. Josep Trueta Girona
Spain H. Clinico San Cecilio Granada
Spain Hospital HLA Inmaculada Granada
Spain H. de Guadalajara Guadalajara
Spain H. de Guadarrama Guadarrama
Spain H. Juan Ramón Jiménez Huelva
Spain H. Riotinto Huelva
Spain H. Can Misses Ibiza
Spain H. Universitario de Jaén Jaén
Spain H. Univ. de Jerez de la Frontera Jerez De La Frontera
Spain H. Univ Insular de Gran Canaria Las Palmas De Gran Canaria
Spain H. Universitario de Gran Canaria Dr. Negrin Las Palmas De Gran Canaria
Spain H. Univ. Severo Ochoa Leganés
Spain H. San Pedro Logroño
Spain H. Univ. Menez Rafael Mendez Lorca
Spain H. Lucus Augusti Lugo
Spain H. 12 de Octubre Madrid
Spain H. Clinica Univ. de Navarra_ Campus Madrid Madrid
Spain H. Clinico San Carlos Madrid
Spain H. Fundacion Jiménez Díaz Madrid
Spain H. Gral de la Defensa Gomez Ulla Madrid
Spain H. HLA Univ. Moncloa Madrid
Spain H. HM Sanchinarro Madrid
Spain H. Puerta de Hierro Madrid
Spain H. Univ HM Madrid Madrid
Spain H. Univ Principe de Asturias Madrid
Spain H. Univ. de Alcorcón Madrid
Spain H. Univ. de Getafe Madrid
Spain H. Univ. de Móstoles Madrid
Spain H. Univ. Gregorio Marañon Madrid
Spain H. Univ. HM Monteprincipe Madrid
Spain H. UNiv. HM Puerta del Sur Madrid
Spain H. Univ. Infanta Leonor Madrid
Spain H. Univ. La Paz Madrid
Spain H. Univ. La Princesa Madrid
Spain H. Univ. Ramón y Cajal Madrid
Spain H. Univ. Rey Juan Carlos Madrid
Spain H. Marbella Internacional Málaga
Spain H. Virgen de la Victoria Málaga
Spain H. Costa del Sol Marbella
Spain H. de Mataro Mataró
Spain H. de Melilla Melilla
Spain H. de Mendaro Mendaro
Spain Hospital Alto Deba Mondragón
Spain H. Virgen de la Arrixaca Murcia
Spain H. Vega Baja Orihuela
Spain H. Univ. Central de Asturias Oviedo
Spain H. de Palamos Palamós
Spain H. Son Espases Palma De Mallorca
Spain H. Son Llatzer Palma De Mallorca
Spain H. Clinica Univ. Navarra Pamplona
Spain H. Virgen del Puerto Plasencia
Spain H. El Bierzo Ponferrada
Spain H. Do Salnes Pontevedra
Spain H. UNiv. Los Arcos del Mar Menor Pozo Aledo
Spain H. Santa Barbara Puertollano
Spain H. Parc Tauli Sabadell
Spain Complejo Asist. Univ. de Salamanca Salamanca
Spain H. de Donostia San Sebastián
Spain H. Infanta Sofia San Sebastián De Los Reyes
Spain H. de l'Esperit Sant Santa Coloma De Gramenet
Spain H. Univ. Marques de Valdecilla Santander
Spain H. Clinico Univ. Santiago de Compostela Santiago De Compostela
Spain H. Univ de Valme Sevilla
Spain H. Univ. Virgen del Rocio Sevilla
Spain H. Univ. Virgen Macarena Sevilla
Spain H. Virgen Macarena Sevilla
Spain H. Univ Joan XXIII Tarragona
Spain H. U. de Canarias Tenerife
Spain H. Univ. Nuestra Sra. de la Candelaria Tenerife
Spain H. Mutua de Terrasa Terrassa
Spain Complejo Hospitalario Virgen de la Salud Toledo
Spain H. Univ. HM Torrelodones Torrelodones
Spain H. Quiron Salud Torrevieja Torrevieja
Spain H. Virgen de la Cinta Tortosa
Spain H. Reina Sofia de Tudela Tudela
Spain H. Arnau de Vilanova-Lliria Valencia
Spain H. Clinico Univ. de Valencia Valencia
Spain H. de Sagunto Valencia
Spain H. Univ. y Polit. La Fe Valencia
Spain H. Clin. Univ. de Valladolid Valladolid
Spain H. Rio Hortega Valladolid
Spain H. Alvaro Cunqueiro Vigo
Spain H. de Viladecans Viladecans
Spain H. de la Marina Baixa Villajoyosa
Spain Hospital de la Plana Villareal
Spain H. Univ de Alava Vitoria
Spain H. Virgen de la Concha Zamora
Spain H. Lozano Blesa Zaragoza
Spain H. Miguel Servet Zaragoza
Spain H. Ntra. Sra. de Gracia Zaragoza

Sponsors (1)
Lead Sponsor Collaborator
Fundacion SEIMC-GESIDA

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall mortality 28 days
Secondary Mechanical ventilation 28 days
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