An observational study in Covid19, sponsored by Fundacion SEIMC-GESIDA. Completed at 128 sites in Spain. Per ClinicalTrials.gov, last updated 2023-07-03.
Sponsored by Fundacion SEIMC-GESIDA · Observational
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
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.
7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's enrollment of 4,035 is above the median of 260 across 3,188 observational studies indexed under COVID-19.
Browse COVID-19 studies →Fundacion SEIMC-GESIDA is the lead sponsor of 30 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Overall mortality
Time frame: 28 days
Mechanical ventilation
Time frame: 28 days
Showing the first 100 of 128 sites.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fundacion SEIMC-GESIDA