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Covid19COVID19@SpainNCT04355871

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

An observational study of Covid19, run by Fundacion SEIMC-GESIDA at 128 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Any age
Conditions the study is for
Covid19
How many people
4,035 participants
Where
128 sitesSpain
Study dates
18 Mar 2020to 17 Apr 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

128 sites in 1 country.

128 sites in 1 country

Spain128 sites

  • Comp. Hosp. Univ. A Coruña

    A Coruña

  • H. Quiron A Coruña

    A Coruña

  • H. de Alcaniz

    Alcañiz

  • H. Gral Univ. de Alicante

    Alicante

  • H. Univ. San Juan de Alicante

    Alicante

  • H. Univ. de la Ribera

    Alzira

  • H. Santos Reyes

    Aranda de Duero

  • Hospital Alto Deba

    Arrasate / Mondragón

  • H. Dr. Jose Molina Orosa

    Arrecife

  • Complejo Asistencial de Avila

    Ávila

  • Consorcio Sanitari Integral (CAIDM)

    Barcelona

  • H. Clinic

    Barcelona

  • H. del Mar

    Barcelona

  • H. Parc Sanitari Sant Joan de Deu

    Barcelona

  • H. Santa Creu y Sant Pau

    Barcelona

  • H. Univ. de Bellvitge

    Barcelona

  • H. Vall d'Hebron

    Barcelona

  • Hospital CIMA-Sanitas

    Barcelona

  • SCIAS H. de Barcelona

    Barcelona

  • H. Clinica de Benidorm

    Benidorm

  • H. de Cruces

    Bilbao

  • H. San Eloy_Barakaldo

    Bilbao

  • H. Univ. de Basurto

    Bilbao

  • H. Urduliz-Alfredo Espinosa

    Bilbao

  • H. Gral de La Palma

    Breña Alta

  • H. de Puerto Real

    Cadiz

  • H. de Calahorra

    Calahorra

  • H. Sant Jaume de Calella

    Calella

  • H. Univ Santa Lucia

    Cartagena

  • H. Univ de Henares

    Coslada

  • Hospital Marina Salud de Dénia

    Denia

  • Hospital Don Benito-Villanueva de la Serena

    Don Benito

  • H. Gral Univ. de Elche

    Elche

  • H. Univ. del Vinalopo

    Elche

  • Comp. Hospt. Univ. de Ferrol

    Ferrol

  • H. Francesc de Borja

    Gandia

  • H. Comarcal de Blanes

    Girona

  • H. de Figueres

    Girona

  • H. Josep Trueta

    Girona

  • H. Clinico San Cecilio

    Granada

  • Hospital HLA Inmaculada

    Granada

  • H. de Guadalajara

    Guadalajara

  • H. de Guadarrama

    Guadarrama

  • H. Juan Ramón Jiménez

    Huelva

  • H. Riotinto

    Huelva

  • H. Can Misses

    Ibiza Town

  • H. Universitario de Jaén

    Jaén

  • H. Univ. de Jerez de la Frontera

    Jerez de la Frontera

  • H. Univ Insular de Gran Canaria

    Las Palmas de Gran Canaria

  • H. Universitario de Gran Canaria Dr. Negrin

    Las Palmas de Gran Canaria

  • H. Univ. Severo Ochoa

    Leganés

  • H. San Pedro

    Logroño

  • H. Univ. Menez Rafael Mendez

    Lorca

  • H. Lucus Augusti

    Lugo

  • H. 12 de Octubre

    Madrid

  • H. Clinica Univ. de Navarra_ Campus Madrid

    Madrid

  • H. Clinico San Carlos

    Madrid

  • H. Fundacion Jiménez Díaz

    Madrid

  • H. Gral de la Defensa Gomez Ulla

    Madrid

  • H. HLA Univ. Moncloa

    Madrid

  • H. HM Sanchinarro

    Madrid

  • H. Puerta de Hierro

    Madrid

  • H. Univ HM Madrid

    Madrid

  • H. Univ Principe de Asturias

    Madrid

  • H. Univ. de Alcorcón

    Madrid

  • H. Univ. de Getafe

    Madrid

  • H. Univ. de Móstoles

    Madrid

  • H. Univ. Gregorio Marañon

    Madrid

  • H. Univ. HM Monteprincipe

    Madrid

  • H. UNiv. HM Puerta del Sur

    Madrid

  • H. Univ. Infanta Leonor

    Madrid

  • H. Univ. La Paz

    Madrid

  • H. Univ. La Princesa

    Madrid

  • H. Univ. Ramón y Cajal

    Madrid

  • H. Univ. Rey Juan Carlos

    Madrid

  • H. Marbella Internacional

    Málaga

  • H. Virgen de la Victoria

    Málaga

  • H. Costa del Sol

    Marbella

  • H. de Mataro

    Mataró

  • H. de Melilla

    Melilla

  • H. de Mendaro

    Mendaro

  • H. Virgen de la Arrixaca

    Murcia

  • H. Vega Baja

    Orihuela

  • H. Univ. Central de Asturias

    Oviedo

  • H. de Palamos

    Palamós

  • H. Son Espases

    Palma de Mallorca

  • H. Son Llatzer

    Palma de Mallorca

  • H. Clinica Univ. Navarra

    Pamplona

  • H. Virgen del Puerto

    Plasencia

  • H. El Bierzo

    Ponferrada

  • H. Do Salnes

    Pontevedra

  • H. UNiv. Los Arcos del Mar Menor

    Pozo-Aledo

  • H. Santa Barbara

    Puertollano

  • H. Parc Tauli

    Sabadell

  • Complejo Asist. Univ. de Salamanca

    Salamanca

  • H. de Donostia

    San Sebastián

  • H. Infanta Sofia

    San Sebastián de los Reyes

  • H. de l'Esperit Sant

    Santa Coloma de Gramenet

  • H. U. de Canarias

    Santa Cruz de Tenerife

  • H. Univ. Nuestra Sra. de la Candelaria

    Santa Cruz de Tenerife

  • H. Univ. Marques de Valdecilla

    Santander

  • H. Clinico Univ. Santiago de Compostela

    Santiago de Compostela

  • H. Univ de Valme

    Seville

  • H. Univ. Virgen del Rocio

    Seville

  • H. Univ. Virgen Macarena

    Seville

  • H. Virgen Macarena

    Seville

  • H. Univ Joan XXIII

    Tarragona

  • H. Mutua de Terrasa

    Terrassa

  • Complejo Hospitalario Virgen de la Salud

    Toledo

  • H. Univ. HM Torrelodones

    Torrelodones

  • H. Quiron Salud Torrevieja

    Torrevieja

  • H. Virgen de la Cinta

    Tortosa

  • H. Reina Sofia de Tudela

    Tudela

  • H. Arnau de Vilanova-Lliria

    Valencia

  • H. Clinico Univ. de Valencia

    Valencia

  • H. de Sagunto

    Valencia

  • H. Univ. y Polit. La Fe

    Valencia

  • H. Clin. Univ. de Valladolid

    Valladolid

  • H. Rio Hortega

    Valladolid

  • H. Alvaro Cunqueiro

    Vigo

  • H. de Viladecans

    Viladecans

  • H. de la Marina Baixa

    Villajoyosa

  • Hospital de la Plana

    Villarreal de Huerva

  • H. Univ de Alava

    Vitoria-Gasteiz

  • H. Virgen de la Concha

    Zamora

  • H. Lozano Blesa

    Zaragoza

  • H. Miguel Servet

    Zaragoza

  • H. Ntra. Sra. de Gracia

    Zaragoza

Other trials in Spain

About this study

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

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

Read the 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
Keywords
Covid19, SARS-CoV-2, Coronavirus
Medical subject headings
COVID-19, Coronavirus Infections

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall mortality

    Measured: 28 days

Secondary outcomes (1)

  1. Mechanical ventilation

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2020
  2. Study start18 Mar 2020
  3. Primary completion15 Apr 2020
  4. Study completion17 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
4,035 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04355871
Sponsor's protocol ID
COVID-19/SEIMC-FSG
Acronym
COVID19@Spain
Status last verified
Apr 2020
First submitted
19 Apr 2020
Last updated
3 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19, run by Fundacion SEIMC-GESIDA at 128 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 128 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04355871.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.

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