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

NCT ID: NCT04355871

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4035 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-18
• Study Completion Date: 2020-04-17

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

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.

Conditions

Covid19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacion SEIMC-GESIDA

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose Ramón Arribas, MD

Role: PRINCIPAL_INVESTIGATOR

H. Univ. La Paz

Juan Berenguer, MD

Role: PRINCIPAL_INVESTIGATOR

H. Univ. Gregorio Marañón

Pablo Ryan, MD

Role: PRINCIPAL_INVESTIGATOR

H. Univ. Infanta Leonor

Jesús Rodriguez Baños, MD

Role: PRINCIPAL_INVESTIGATOR

H. Univ. Virgen Macarena

Jordi Carratala, MD

Role: PRINCIPAL_INVESTIGATOR

H. Univ. de Bellvitge

Jerónimo Pachón, MD

Role: PRINCIPAL_INVESTIGATOR

H. Univ. VIrgen del Rocio

Locations

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

Hospital Alto Deba

Arrasate / Mondragón, , 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. Comarcal de Blanes

Girona, , Spain

H. de Figueres

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 Town, , 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. Costa del Sol

Marbella, , Spain

H. de Mataro

Mataró, , Spain

H. Marbella Internacional

Málaga, , Spain

H. Virgen de la Victoria

Málaga, , Spain

H. de Melilla

Melilla, , Spain

H. de Mendaro

Mendaro, , 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. U. de Canarias

Santa Cruz de Tenerife, , Spain

H. Univ. Nuestra Sra. de la Candelaria

Santa Cruz de Tenerife, , Spain

H. Univ. Marques de Valdecilla

Santander, , Spain

H. Clinico Univ. Santiago de Compostela

Santiago de Compostela, , Spain

H. Univ de Valme

Seville, , Spain

H. Univ. Virgen del Rocio

Seville, , Spain

H. Univ. Virgen Macarena

Seville, , Spain

H. Virgen Macarena

Seville, , Spain

H. Univ Joan XXIII

Tarragona, , 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

Villarreal de Huerva, , Spain

H. Univ de Alava

Vitoria-Gasteiz, , Spain

H. Virgen de la Concha

Zamora, , Spain

H. Lozano Blesa

Zaragoza, , Spain

H. Miguel Servet

Zaragoza, , Spain

H. Ntra. Sra. de Gracia

Zaragoza, , Spain

Countries

Spain

Other Identifiers

COVID-19/SEIMC-FSG

Identifier Type: -

Identifier Source: org_study_id