COVID-19 Infection Clinical Trial
Official title:
Effect of Immunosupressive Treatment in COVID-19 Patients Whit SAM-LIKE Profile: Retrospective Cohort Study (SAM-COVID Project)
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.
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.
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