COVID-19 Infection
Conditions
Keywords
COVID-19, SARS-CoV-2, Immunosuppressive, Immunoglubulins
Brief 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.
Detailed 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.
Interventions
DRUGNO-Immunosuppressive
Patients not receiving immunosuppressive drugs
Patients receiving immunosuppressive drugs (overall, and specific drugs)
DRUGImmunoglubulins
Patients receiving immunoglubulins
Sponsors
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Spanish Network for Research in Infectious Diseases
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (≥18 years) admitted because of COVID-19 confirmed by PCR in nasopharyngeal swab or lower respiratory tract sample and presenting on a specific date (day 0) one clinical and one laboratory criteria of the following: Clinical criteria: * Temperature ≥38ºC. * Worsening in oxygen requirements to achieve O2 saturation \>92%. Laboratory criteria: * Ferritin \>2000 ng/mL or increment in \>1000 ng/ML since admission. * D-dimer \>1500 µg/mL (or duplicate in 24h) * IL6 \>50 pg/mL.
Exclusion criteria
* Mechanical ventilation in day 0. * Decision of provide only palliative care before day 0. * Use of systemic steroids, tocilizumab, other immunosupressors, or immunoglobulins before day 0.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Invasive ventilation or death | Up to 21 days | Days until invasive mechanical ventilation or death, whatever happened first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilation | Up to 21 days | Days until mechanical ventilation |
| Death | Up to 21 days | Days until death |
| Secondary infections | Up to 21 days | Proportion of patients developing secondary infections |
| Digestive tract hemorrhage | Up to 21 days | Proportion of patients with digestive tract hemorrhage |
| Change in 7 points scale | Day 21 | Proportion of patients with imnprovement in 2 or more points in 7-point scale by WHO |
Countries
Spain
Contacts
Primary ContactSánchez-Barriga
Outcome results
None listed