Status:
UNKNOWN
Immunosupressive Treatment in COVID-19 Patients
Lead Sponsor:
Spanish Network for Research in Infectious Diseases
Collaborating Sponsors:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Conditions:
COVID-19 Infection
Eligibility:
All Genders
18+ years
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 acu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2020
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04382781
Start Date
May 1 2020
End Date
May 1 2020
Last Update
May 12 2020
Active Locations (1)
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1
Hospital Virgen Macarena
Seville, Spain, 41071