Clinical trial NCT04382781: Immunosupressive Treatment in COVID-19 Patients
Official title: Effect of Immunosupressive Treatment in COVID-19 Patients Whit SAM-LIKE Profile: Retrospective Cohort Study (SAM-COVID Project)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Infection
Keywords: COVID-19
SARS-CoV-2
Immunosuppressive
Immunoglubulins
Lead sponsor: Spanish Network for Research in Infectious Diseases
Sponsor class: OTHER
Collaborators: name: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
First posted: 2020-05-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 .

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Invasive ventilation or death
timeFrame: Up to 21 days
Secondary outcomes:
measure: Ventilation
timeFrame: Up to 21 days
measure: Death
timeFrame: Up to 21 days
measure: Secondary infections
timeFrame: Up to 21 days
measure: Digestive tract hemorrhage
timeFrame: Up to 21 days
measure: Change in 7 points scale
timeFrame: Day 21
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
Study officials:
References: