Immunosupressive Treatment in COVID-19 Patients (SAM-COVID)
Effect of Immunosupressive Treatment in COVID-19 Patients Whit SAM-LIKE Profile: Retrospective Cohort Study (SAM-COVID Project)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienorte
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Sevilla, Spanien, 41071
- Rekrutierung
- Hospital Virgen Macarena
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Hauptermittler:
- Jesús Rodriguez-Baño, MD, PhD
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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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 .
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Patients not receiving immunosuppressive drugs
Patients receiving immunosuppressive drugs (overall, and specific drugs)
Patients receiving immunoglubulins
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Invasive ventilation or death
Zeitfenster: Up to 21 days
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Days until invasive mechanical ventilation or death, whatever happened first.
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Up to 21 days
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Ventilation
Zeitfenster: Up to 21 days
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Days until mechanical ventilation
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Up to 21 days
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Death
Zeitfenster: Up to 21 days
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Days until death
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Up to 21 days
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Secondary infections
Zeitfenster: Up to 21 days
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Proportion of patients developing secondary infections
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Up to 21 days
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Digestive tract hemorrhage
Zeitfenster: Up to 21 days
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Proportion of patients with digestive tract hemorrhage
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Up to 21 days
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Change in 7 points scale
Zeitfenster: Day 21
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Proportion of patients with imnprovement in 2 or more points in 7-point scale by WHO
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Day 21
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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Voraussichtlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Coronavirus-Infektionen
- Coronaviridae-Infektionen
- Nidovirales-Infektionen
- RNA-Virusinfektionen
- Viruserkrankungen
- Infektionen
- Infektionen der Atemwege
- Erkrankungen der Atemwege
- Pneumonie, viral
- Lungenentzündung
- Lungenkrankheit
- COVID-19
- Physiologische Wirkungen von Arzneimitteln
- Immunologische Faktoren
- Immunsuppressive Mittel
Andere Studien-ID-Nummern
- FIS-INM-2020-03
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