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.
Study Type
OBSERVATIONAL
Enrollment
500
Patients not receiving immunosuppressive drugs
Patients receiving immunosuppressive drugs (overall, and specific drugs)
Patients receiving immunoglubulins
Hospital Virgen Macarena
Seville, Spain
RECRUITINGInvasive ventilation or death
Days until invasive mechanical ventilation or death, whatever happened first.
Time frame: Up to 21 days
Ventilation
Days until mechanical ventilation
Time frame: Up to 21 days
Death
Days until death
Time frame: Up to 21 days
Secondary infections
Proportion of patients developing secondary infections
Time frame: Up to 21 days
Digestive tract hemorrhage
Proportion of patients with digestive tract hemorrhage
Time frame: Up to 21 days
Change in 7 points scale
Proportion of patients with imnprovement in 2 or more points in 7-point scale by WHO
Time frame: Day 21
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