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Clinical Trial Summary

SAM-COVID is a retrospective cohort study that aims to determine the impact of immunosuppressive drugs and immunoglubulins in the outcome of patients with COVID-19.


Clinical Trial Description

SAM-COVID is a retrospective cohort study of patients admitted to 66 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) presenting during admission with clinical and laboratory data suggestive of macrophage activation syndrome with the objective to investigate whether the use of immunosuppressive drugs (including high-dose steroids, tocilizumab, sarilumab, anakimra) or immunoglobulins in avoiding the need for invasive mechanical ventilation or in-hospital death.

The Ethics Committee for Research of Virgen Macarena and Virgen del Rocío University Hospitals approved the study and waived the need to obtain informed consent.

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, demographics, comorbidities and current medications, signs and symptoms at admission, baseline laboratory tests results and at day 0, chest X-ray findings at baseline and during follow-up, medications with potential activity against COVID-19, supportive treatments including oxygen therapy, use of immunosuppressant medications or immunoglobulins, and outcome. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04382781
Study type Observational
Source Spanish Network for Research in Infectious Diseases
Contact Sánchez-Barriga
Phone +34 600162652
Email maria.sanchezbarriga@juntadeandalucia.es
Status Recruiting
Phase
Start date May 2020
Completion date May 2020

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