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

Completed

• Conditions: Covid19

• Registration Number: NCT04355871
• Lead Sponsor: 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

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 Timeline

• Study Start: 2020-03-18
• Status Verified: 2020-04
• Primary Completion: 2020-04-15
• Study Completion: 2020-04-17
• Study First Submitted: 2020-04-19
• Study First Submitted QC: 2020-04-19
• Study First Posted: 2020-04-21
• Last Update Submitted: 2023-06-29
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4035

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall mortality	28 days

Secondary Outcome Measures

Name	Time	Method
Mechanical ventilation	28 days

Trial Locations

Locations (128)

Comp. Hosp. Univ. A Coruña; 🇪🇸 A Coruña, Spain

H. Quiron A Coruña; 🇪🇸 A Coruña, Spain

H. de Alcaniz; 🇪🇸 Alcañiz, Spain

H. Gral Univ. de Alicante; 🇪🇸 Alicante, Spain

H. Univ. San Juan de Alicante; 🇪🇸 Alicante, Spain

H. Univ. de la Ribera; 🇪🇸 Alzira, Spain

H. Santos Reyes; 🇪🇸 Aranda De Duero, Spain

H. Dr. Jose Molina Orosa; 🇪🇸 Arrecife, Spain

Consorcio Sanitari Integral (CAIDM); 🇪🇸 Barcelona, Spain

H. Clinic; 🇪🇸 Barcelona, Spain

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