Immunosupressive Treatment in COVID-19 Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Immunosupressive Treatment in COVID-19 Patients Whit SAM-LIKE Profile: Retrospective Cohort Study (SAM-COVID Project)

Conditions
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COVID-19 Infection

Intervention / Treatment
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* Drug: NO-Immunosuppressive
* Drug: Immunosuppressive
* Drug: Immunoglubulins


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 infection<br>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 . | Drug: NO-Immunosuppressive<br>* Patients not receiving immunosuppressive drugs<br>Drug: Immunosuppressive<br>* Patients receiving immunosuppressive drugs (overall, and specific drugs)<br>Drug: Immunoglubulins<br>* Patients receiving immunoglubulins<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Invasive ventilation or death | Days until invasive mechanical ventilation or death, whatever happened first. | Up to 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilation | Days until mechanical ventilation | Up to 21 days | 
| Death | Days until death | Up to 21 days | 
| Secondary infections | Proportion of patients developing secondary infections | Up to 21 days | 
| Digestive tract hemorrhage | Proportion of patients with digestive tract hemorrhage | 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 | Day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, SARS-CoV-2, Immunosuppressive, Immunoglubulins