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

9. maj 2020 opdateret af: JESUS RODRIGUEZ BAÑO, Spanish Network for Research in Infectious Diseases

Effect of Immunosupressive Treatment in COVID-19 Patients Whit SAM-LIKE Profile: Retrospective Cohort Study (SAM-COVID Project)

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.

Studieoversigt

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

500

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Sevilla, Spanien, 41071
        • Rekruttering
        • Hospital Virgen Macarena
        • Ledende efterforsker:
          • Jesús Rodriguez-Baño, MD, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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 .

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / 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 .
Patients not receiving immunosuppressive drugs
Patients receiving immunosuppressive drugs (overall, and specific drugs)
Patients receiving immunoglubulins

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Invasive ventilation or death
Tidsramme: Up to 21 days
Days until invasive mechanical ventilation or death, whatever happened first.
Up to 21 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ventilation
Tidsramme: Up to 21 days
Days until mechanical ventilation
Up to 21 days
Death
Tidsramme: Up to 21 days
Days until death
Up to 21 days
Secondary infections
Tidsramme: Up to 21 days
Proportion of patients developing secondary infections
Up to 21 days
Digestive tract hemorrhage
Tidsramme: Up to 21 days
Proportion of patients with digestive tract hemorrhage
Up to 21 days
Change in 7 points scale
Tidsramme: Day 21
Proportion of patients with imnprovement in 2 or more points in 7-point scale by WHO
Day 21

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. maj 2020

Primær færdiggørelse (Forventet)

1. maj 2020

Studieafslutning (Forventet)

1. maj 2020

Datoer for studieregistrering

Først indsendt

6. maj 2020

Først indsendt, der opfyldte QC-kriterier

7. maj 2020

Først opslået (Faktiske)

11. maj 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. maj 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. maj 2020

Sidst verificeret

1. maj 2020

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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