- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04382781
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)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Sánchez-Barriga
- Telefonnummer: +34 600162652
- E-post: maria.sanchezbarriga@juntadeandalucia.es
Studiesteder
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Sevilla, Spania, 41071
- Rekruttering
- Hospital Virgen Macarena
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Hovedetterforsker:
- Jesús Rodriguez-Baño, MD, PhD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Invasive ventilation or death
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Ventilation
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Coronavirus-infeksjoner
- Coronaviridae-infeksjoner
- Nidovirales infeksjoner
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Luftveisinfeksjoner
- Sykdommer i luftveiene
- Lungebetennelse, viral
- Lungebetennelse
- Lungesykdommer
- Covid-19
- Fysiologiske effekter av legemidler
- Immunologiske faktorer
- Immunsuppressive midler
Andre studie-ID-numre
- FIS-INM-2020-03
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