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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04355871
Recruitment Status : Completed
First Posted : April 21, 2020
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
Fundacion SEIMC-GESIDA

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

Condition or disease
Covid19

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.

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Study Type : Observational
Actual Enrollment : 4035 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Characteristics and Predictors of Death Among Hospitalized Patients With COVID-19 in Spain
Actual Study Start Date : March 18, 2020
Actual Primary Completion Date : April 15, 2020
Actual Study Completion Date : April 17, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Overall mortality [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Mechanical ventilation [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04355871


Locations
Show Show 128 study locations
Sponsors and Collaborators
Fundacion SEIMC-GESIDA
Investigators
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Principal Investigator: Jose Ramón Arribas, MD H. Univ. La Paz
Principal Investigator: Juan Berenguer, MD H. Univ. Gregorio Marañón
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
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Responsible Party: Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier: NCT04355871    
Other Study ID Numbers: COVID-19/SEIMC-FSG
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundacion SEIMC-GESIDA:
Covid19
SARS-CoV-2
Coronavirus
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases