Immunosupressive Treatment in COVID-19 Patients
SAM-COVID
Effect of Immunosupressive Treatment in COVID-19 Patients Whit SAM-LIKE Profile: Retrospective Cohort Study (SAM-COVID Project)
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedFirst Submitted
Initial submission to the registry
May 6, 2020
CompletedFirst Posted
Study publicly available on registry
May 11, 2020
CompletedMay 12, 2020
May 1, 2020
Same day
May 6, 2020
May 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Invasive ventilation or death
Days until invasive mechanical ventilation or death, whatever happened first.
Up to 21 days
Secondary Outcomes (5)
Ventilation
Up to 21 days
Death
Up to 21 days
Secondary infections
Up to 21 days
Digestive tract hemorrhage
Up to 21 days
Change in 7 points scale
Day 21
Study Arms (1)
COVID-19 infection
Consecutive patients admitted to 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) who showed clinical and analytical data suggestive of macrophage activation syndrome during admission until March 30, 2020 .
Interventions
Patients receiving immunosuppressive drugs (overall, and specific drugs)
Eligibility Criteria
Consecutive patients admitted to 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) who showed clinical and analytical data suggestive of macrophage activation syndrome during admission until March 30, 2020 .
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Virgen Macarena
Seville, 41071, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Infectious Diseases Service of the HU Virgen Macarena
Study Record Dates
First Submitted
May 6, 2020
First Posted
May 11, 2020
Study Start
May 1, 2020
Primary Completion
May 1, 2020
Study Completion
May 1, 2020
Last Updated
May 12, 2020
Record last verified: 2020-05