Characteristics and Outcomes of Hospitalized Patients With COVID-19 in Spain (COVID19@Spain)
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|ClinicalTrials.gov Identifier: NCT04355871|
Recruitment Status : Completed
First Posted : April 21, 2020
Last Update Posted : May 11, 2020
|Condition or disease|
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 :||Observational|
|Actual Enrollment :||4035 participants|
|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|
- Overall mortality [ Time Frame: 28 days ]
- Mechanical ventilation [ Time Frame: 28 days ]
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
|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|