Immunosupressive Treatment in COVID-19 Patients (SAM-COVID)

Spanish Network for Research in Infectious Diseases

Status: Unknown

Conditions: COVID-19 Infection

Treatments: Drug: NO-Immunosuppressive; Drug: Immunoglubulins; Drug: Immunosuppressive

Study type: Observational

Funder types: Other

Identifiers

NCT04382781

FIS-INM-2020-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 1 patient group

COVID-19 infection

Description:

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 .

Treatment:

Drug: Immunosuppressive

Drug: NO-Immunosuppressive

Drug: Immunoglubulins