Characteristics and Outcomes of Hospitalized Patients With COVID-19 in Spain (COVID19@Spain)

June 29, 2023 updated by: Fundacion SEIMC-GESIDA

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4035

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall mortality
Time Frame: 28 days
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Mechanical ventilation
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundacion SEIMC-GESIDA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jose Ramón Arribas, MD, H. Univ. La Paz
  • Principal Investigator: Juan Berenguer, MD, H. Univ. Gregorio Marañon
  • Principal Investigator: Pablo Ryan, MD, H. Univ. Infanta Leonor
  • Principal Investigator: Jesús Rodriguez Baños, MD, H. Univ. Virgen Macarena
  • Principal Investigator: Jordi Carratala, MD, H. Univ. de Bellvitge
  • Principal Investigator: Jerónimo Pachón, MD, H. Univ. Virgen del Rocio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 18, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 17, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COVID-19/SEIMC-FSG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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