Clinical trial NCT04355871: Characteristics and Outcomes of Hospitalized Patients With COVID-19 in Spain
Official title: Characteristics and Predictors of Death Among Hospitalized Patients With COVID-19 in Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Covid19
SARS-CoV-2
Coronavirus
Lead sponsor: Fundacion SEIMC-GESIDA
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 4035
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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). 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Overall mortality
timeFrame: 28 days
Secondary outcomes:
measure: Mechanical ventilation
timeFrame: 28 days
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Comp. Hosp. Univ. A Coruña
city: A Coruña
country: Spain
facility: H. Quiron A Coruña
city: Alcañiz
country: Spain
facility: H. de Alcaniz
city: Alicante
country: Spain
facility: H. Gral Univ. de Alicante
city: Alicante
country: Spain
facility: H. Univ. San Juan de Alicante
city: Alzira
country: Spain
facility: H. Univ. de la Ribera
city: Aranda De Duero
country: Spain
facility: H. Santos Reyes
city: Arrecife
country: Spain
facility: H. Dr. Jose Molina Orosa
city: Barcelona
country: Spain
facility: Consorcio Sanitari Integral (CAIDM)
city: Barcelona
country: Spain
facility: H. Clinic
city: Barcelona
country: Spain
facility: H. del Mar
city: Barcelona
country: Spain
facility: H. Parc Sanitari Sant Joan de Deu
city: Barcelona
country: Spain
facility: H. Santa Creu y Sant Pau
city: Barcelona
country: Spain
facility: H. Univ. de Bellvitge
city: Barcelona
country: Spain
facility: H. Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital CIMA-Sanitas
city: Barcelona
country: Spain
facility: SCIAS H. de Barcelona
city: Benidorm
country: Spain
facility: H. Clinica de Benidorm
city: Bilbao
country: Spain
facility: H. de Cruces
city: Bilbao
country: Spain
facility: H. San Eloy_Barakaldo
city: Bilbao
country: Spain
facility: H. Univ. de Basurto
city: Bilbao
country: Spain
facility: H. Urduliz-Alfredo Espinosa
city: Breña Alta
country: Spain
facility: H. Gral de La Palma
city: Cadiz
country: Spain
facility: H. de Puerto Real
city: Calahorra
country: Spain
facility: H. de Calahorra
city: Calella
country: Spain
facility: H. Sant Jaume de Calella
city: Cartagena
country: Spain
facility: H. Univ Santa Lucia
city: Coslada
country: Spain
facility: H. Univ de Henares
city: Denia
country: Spain
facility: Hospital Marina Salud de Dénia
city: Don Benito
country: Spain
facility: Hospital Don Benito-Villanueva de la Serena
city: Elche
country: Spain
facility: H. Gral Univ. de Elche
city: Elche
country: Spain
facility: H. Univ. del Vinalopo
city: Ferrol
country: Spain
facility: Comp. Hospt. Univ. de Ferrol
city: Gandia
country: Spain
facility: H. Francesc de Borja
city: Gerona
country: Spain
facility: H. de Figueres
city: Girona
country: Spain
facility: H. Comarcal de Blanes
city: Girona
country: Spain
facility: H. Josep Trueta
city: Granada
country: Spain
facility: H. Clinico San Cecilio
city: Granada
country: Spain
facility: Hospital HLA Inmaculada
city: Guadalajara
country: Spain
facility: H. de Guadalajara
city: Guadarrama
country: Spain
facility: H. de Guadarrama
city: Huelva
country: Spain
facility: H. Juan Ramón Jiménez
city: Huelva
country: Spain
facility: H. Riotinto
city: Ibiza
country: Spain
facility: H. Can Misses
city: Jaén
country: Spain
facility: H. Universitario de Jaén
city: Jerez De La Frontera
country: Spain
facility: H. Univ. de Jerez de la Frontera
city: Las Palmas De Gran Canaria
country: Spain
facility: H. Univ Insular de Gran Canaria
city: Las Palmas De Gran Canaria
country: Spain
facility: H. Universitario de Gran Canaria Dr. Negrin
city: Leganés
country: Spain
facility: H. Univ. Severo Ochoa
city: Logroño
country: Spain
facility: H. San Pedro
city: Lorca
country: Spain
facility: H. Univ. Menez Rafael Mendez
city: Lugo
country: Spain
facility: H. Lucus Augusti
city: Madrid
country: Spain
facility: H. 12 de Octubre
city: Madrid
country: Spain
facility: H. Clinica Univ. de Navarra_ Campus Madrid
city: Madrid
country: Spain
facility: H. Clinico San Carlos
city: Madrid
country: Spain
facility: H. Fundacion Jiménez Díaz
city: Madrid
country: Spain
facility: H. Gral de la Defensa Gomez Ulla
city: Madrid
country: Spain
facility: H. HLA Univ. Moncloa
city: Madrid
country: Spain
facility: H. HM Sanchinarro
city: Madrid
country: Spain
facility: H. Puerta de Hierro
city: Madrid
country: Spain
facility: H. Univ HM Madrid
city: Madrid
country: Spain
facility: H. Univ Principe de Asturias
city: Madrid
country: Spain
facility: H. Univ. de Alcorcón
city: Madrid
country: Spain
facility: H. Univ. de Getafe
city: Madrid
country: Spain
facility: H. Univ. de Móstoles
city: Madrid
country: Spain
facility: H. Univ. Gregorio Marañon
city: Madrid
country: Spain
facility: H. Univ. HM Monteprincipe
city: Madrid
country: Spain
facility: H. UNiv. HM Puerta del Sur
city: Madrid
country: Spain
facility: H. Univ. Infanta Leonor
city: Madrid
country: Spain
facility: H. Univ. La Paz
city: Madrid
country: Spain
facility: H. Univ. La Princesa
city: Madrid
country: Spain
facility: H. Univ. Ramón y Cajal
city: Madrid
country: Spain
facility: H. Univ. Rey Juan Carlos
city: Marbella
country: Spain
facility: H. Costa del Sol
city: Mataró
country: Spain
facility: H. de Mataro
city: Melilla
country: Spain
facility: H. de Melilla
city: Mendaro
country: Spain
facility: H. de Mendaro
city: Mondragón
country: Spain
facility: Hospital Alto Deba
city: Murcia
country: Spain
facility: H. Virgen de la Arrixaca
city: Málaga
country: Spain
facility: H. Marbella Internacional
city: Málaga
country: Spain
facility: H. Virgen de la Victoria
city: Orihuela
country: Spain
facility: H. Vega Baja
city: Oviedo
country: Spain
facility: H. Univ. Central de Asturias
city: Palamós
country: Spain
facility: H. de Palamos
city: Palma De Mallorca
country: Spain
facility: H. Son Espases
city: Palma De Mallorca
country: Spain
facility: H. Son Llatzer
city: Pamplona
country: Spain
facility: H. Clinica Univ. Navarra
city: Plasencia
country: Spain
facility: H. Virgen del Puerto
city: Ponferrada
country: Spain
facility: H. El Bierzo
city: Pontevedra
country: Spain
facility: H. Do Salnes
city: Pozo Aledo
country: Spain
facility: H. UNiv. Los Arcos del Mar Menor
city: Puertollano
country: Spain
facility: H. Santa Barbara
city: Sabadell
country: Spain
facility: H. Parc Tauli
city: Salamanca
country: Spain
facility: Complejo Asist. Univ. de Salamanca
city: San Sebastián De Los Reyes
country: Spain
facility: H. Infanta Sofia
city: San Sebastián
country: Spain
facility: H. de Donostia
city: Santa Coloma De Gramenet
country: Spain
facility: H. de l'Esperit Sant
city: Santander
country: Spain
facility: H. Univ. Marques de Valdecilla
city: Santiago De Compostela
country: Spain
facility: H. Clinico Univ. Santiago de Compostela
city: Sevilla
country: Spain
facility: H. Univ de Valme
city: Sevilla
country: Spain
facility: H. Univ. Virgen del Rocio
city: Sevilla
country: Spain
facility: H. Univ. Virgen Macarena
city: Sevilla
country: Spain
facility: H. Virgen Macarena
city: Tarragona
country: Spain
facility: H. Univ Joan XXIII
city: Tenerife
country: Spain
facility: H. U. de Canarias
city: Tenerife
country: Spain
facility: H. Univ. Nuestra Sra. de la Candelaria
city: Terrassa
country: Spain
facility: H. Mutua de Terrasa
city: Toledo
country: Spain
facility: Complejo Hospitalario Virgen de la Salud
city: Torrelodones
country: Spain
facility: H. Univ. HM Torrelodones
city: Torrevieja
country: Spain
facility: H. Quiron Salud Torrevieja
city: Tortosa
country: Spain
facility: H. Virgen de la Cinta
city: Tudela
country: Spain
facility: H. Reina Sofia de Tudela
city: Valencia
country: Spain
facility: H. Arnau de Vilanova-Lliria
city: Valencia
country: Spain
facility: H. Clinico Univ. de Valencia
city: Valencia
country: Spain
facility: H. de Sagunto
city: Valencia
country: Spain
facility: H. Univ. y Polit. La Fe
city: Valladolid
country: Spain
facility: H. Clin. Univ. de Valladolid
city: Valladolid
country: Spain
facility: H. Rio Hortega
city: Vigo
country: Spain
facility: H. Alvaro Cunqueiro
city: Viladecans
country: Spain
facility: H. de Viladecans
city: Villajoyosa
country: Spain
facility: H. de la Marina Baixa
city: Villareal
country: Spain
facility: Hospital de la Plana
city: Vitoria
country: Spain
facility: H. Univ de Alava
city: Zamora
country: Spain
facility: H. Virgen de la Concha
city: Zaragoza
country: Spain
facility: H. Lozano Blesa
city: Zaragoza
country: Spain
facility: H. Miguel Servet
city: Zaragoza
country: Spain
facility: H. Ntra. Sra. de Gracia
city: Ávila
country: Spain
facility: Complejo Asistencial de Avila
Study officials:
affiliation: H. Univ. La Paz
name: Jose Ramón Arribas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: H. Univ. Gregorio Marañón
name: Juan Berenguer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: H. Univ. Infanta Leonor
name: Pablo Ryan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: H. Univ. Virgen Macarena
name: Jesús Rodriguez Baños, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: H. Univ. de Bellvitge
name: Jordi Carratala, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: H. Univ. VIrgen del Rocio
name: Jerónimo Pachón, MD
role: PRINCIPAL_INVESTIGATOR
References: