Immunosupressive Treatment in COVID-19 Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-31

Study Completion Date

2020-05-31

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.

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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.

Conditions

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COVID-19 Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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 .

NO-Immunosuppressive

Intervention Type DRUG

Patients not receiving immunosuppressive drugs

Immunosuppressive

Intervention Type DRUG

Patients receiving immunosuppressive drugs (overall, and specific drugs)

Immunoglubulins

Intervention Type DRUG

Patients receiving immunoglubulins

Interventions

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NO-Immunosuppressive

Patients not receiving immunosuppressive drugs

Intervention Type DRUG

Immunosuppressive

Patients receiving immunosuppressive drugs (overall, and specific drugs)

Intervention Type DRUG

Immunoglubulins

Patients receiving immunoglubulins

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No