Immunosupressive Treatment in COVID-19 Patients

• Conditions: COVID-19 Infection
• Interventions: Drug: NO-Immunosuppressive; Drug: Immunosuppressive; Drug: Immunoglubulins

• Registration Number: NCT04382781
• Lead Sponsor: Spanish Network for Research in Infectious Diseases

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.

Study Timeline

• Status Verified: 2020-05
• Study Start: 2020-05
• Primary Completion: 2020-05
• Study Completion: 2020-05
• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-05-07
• Last Update Submitted: 2020-05-09
• Study First Posted: 2020-05-11
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 infection	Immunosuppressive	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 .
COVID-19 infection	Immunoglubulins	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 .
COVID-19 infection	NO-Immunosuppressive	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 .

Primary Outcome Measures

Name	Time	Method
Invasive ventilation or death	Up to 21 days	Days until invasive mechanical ventilation or death, whatever happened first.

Secondary Outcome Measures

Name	Time	Method
Ventilation	Up to 21 days	Days until mechanical ventilation
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
Death	Up to 21 days	Days until death

Trial Locations

Locations (1)

Hospital Virgen Macarena; 🇪🇸 Sevilla, Spain