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Pilot Study of Antithrombin as Prophylaxis of Acute Respiratory Distress Syndrome in Patients With COVID-19

8. februar 2021 oppdatert av: Maimónides Biomedical Research Institute of Córdoba
Pilot clinical trial, with a marketed drug -natural component of human plasma-, not approved for this indication, single-center, exploratory, open, randomized, controlled, to study the efficacy and safety of human Antithrombin in patients with confirmed COVID-19 disease and criteria high risk to develop SARS.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

48

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Spania
      • Córdoba, Spania, 14004
        • Hospital Universitario Reina Sofia

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Age >= 18 and < 85 years
  • COVID-19 diagnosis confirmed.
  • Radiological image compatible with COVID-19

  • Present any of the following clinical-functional criteria considered RISK:

    1. Respiratory distress: Tachypnea > 26 breaths / minute
    2. PaO2 / FiO2 oxygenation index # 300
    3. Alteration of one or more of the following parameters:

    c.i. DD> 1,000 µg / L c.ii. Ferritin> 800 ng / mL 4.c.iii. Lymphocytes <800 cells / µL 4.c.iv. PCR> 100 mg / L 4.c.v. LDH> 500 U / L c.vi. IL-6> 15 pg / mL

  • Direct or delegated verbal informed consent

Exclusion Criteria:

  • Signs of active bleeding
  • Immunosuppression by cancer or transplant
  • Intolerance or allergy to AT or its components
  • Pregnancy

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Best available treatment + Antithrombin
The subject will be treated with Antithrombin (50 IU/Kg/12h) for 72 hours and the best available treatment for COVID-19.
Legemiddel: Antithrombin + best available treatment
The subject will be treated with Antithrombin (50 IU/Kg/12h) for 72 hours and the best available treatment for COVID-19.
Aktiv komparator: Best available treatment
The subject will be treated with the best available treatment for COVID-19.
Legemiddel: Best available treatment
The subject will be treated with the best available treatment for COVID-19.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Combined variable: mortality or worsening rate with need for non-invasive mechanical ventilation or with need for invasive mechanical ventilation
Tidsramme: At day 31 after randomization or hospital discharge (whichever occurs first)
Combined variable: mortality or worsening rate with need for non-invasive mechanical ventilation or with need for invasive mechanical ventilation
At day 31 after randomization or hospital discharge (whichever occurs first)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to clinical improvement (decreased risk of developing SARS or death)
Tidsramme: At day 31 after randomization or hospital discharge (whichever occurs first)
Time (in days) to improvement in the National Early Warning (NEWS) Score 2. Defined as the time, in days, from the start of treatment a two-point improvement on this scale.
At day 31 after randomization or hospital discharge (whichever occurs first)
Evaluate the improvement of the oxygenation index - PaO2 / FiO2- at 24 and 48 hours.
Tidsramme: At 24 and 48 hours.
Evaluate the improvement of the oxygenation index - PaO2 / FiO2- at 24 and 48 hours.
At 24 and 48 hours.
Improvement of the analytical parameters: time (in days) until the tendency to normalization (decrease >= 20%) of DD, ferritin, LDH, PCR and IL-6; the criteria reached before will be used.
Tidsramme: At day 31 after randomization or hospital discharge (whichever occurs first)
Improvement of the analytical parameters: time (in days) until the tendency to normalization (decrease >= 20%) of DD, ferritin, LDH, PCR and IL-6; the criteria reached before will be used.
At day 31 after randomization or hospital discharge (whichever occurs first)
Time (in days) until improvement in oxygenation: - Time until the SpO2 / FiO2 ratio exceeds the worst SpO2 / FiO2 prior to AT treatment.
Tidsramme: At day 31 after randomization or hospital discharge (whichever occurs first)
Time until the absence of oxygen need to maintain a basal saturation >= 92%.
At day 31 after randomization or hospital discharge (whichever occurs first)
Time to radiological improvement in radiological report.
Tidsramme: At day 31 after randomization or hospital discharge (whichever occurs first)
Time to radiological improvement in radiological report.
At day 31 after randomization or hospital discharge (whichever occurs first)
Time (in days) of non-invasive mechanical ventilation.
Tidsramme: At day 31 after randomization or hospital discharge (whichever occurs first)
Time (in days) of non-invasive mechanical ventilation.
At day 31 after randomization or hospital discharge (whichever occurs first)
Time (in days) of invasive mechanical ventilation.
Tidsramme: At day 31 after randomization or hospital discharge (whichever occurs first)
Time (in days) of invasive mechanical ventilation.
At day 31 after randomization or hospital discharge (whichever occurs first)
Mortality rate in hospital and one month after pharmacological intervention.
Tidsramme: One month after pharmacological intervention.
Mortality rate in hospital and one month after pharmacological intervention.
One month after pharmacological intervention.
Percentage of patients who suffer any adverse effect related to pharmacological intervention.
Tidsramme: One month after pharmacological intervention.
Percentage of patients who suffer any adverse effect related to pharmacological intervention.
One month after pharmacological intervention.
Incidence of adverse events related to medication and its administration.
Tidsramme: At day 31 after randomization or hospital discharge (whichever occurs first)
Incidence of adverse events related to medication and its administration.
At day 31 after randomization or hospital discharge (whichever occurs first)
Incidence in the appearance of allergic type hypersensitivity
Tidsramme: At day 31 after randomization or hospital discharge (whichever occurs first)
Incidence in the appearance of Acne, Generalized urticaria, Chest tightness, Dyspnoea, Hypotension and/or Anaphylaxis.
At day 31 after randomization or hospital discharge (whichever occurs first)
Incidence of B19 parvovirus infection
Tidsramme: At day 31 after randomization or hospital discharge (whichever occurs first)
Incidence of B19 parvovirus infection
At day 31 after randomization or hospital discharge (whichever occurs first)
Bleeding
Tidsramme: At day 31 after randomization or hospital discharge (whichever occurs first)
Incidence of Bleeding
At day 31 after randomization or hospital discharge (whichever occurs first)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Etterforskere

  • Hovedetterforsker: Ángel Salvatierra, MD, Hospital Universitario Reina Sofia

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

27. april 2020

Primær fullføring (Faktiske)

20. desember 2020

Studiet fullført (Faktiske)

15. januar 2021

Datoer for studieregistrering

Først innsendt

8. februar 2021

Først innsendt som oppfylte QC-kriteriene

8. februar 2021

Først lagt ut (Faktiske)

9. februar 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. februar 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. februar 2021

Sist bekreftet

1. februar 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ANTITROMBINA

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-delingstidsramme

The information will be provided after the results are published in a journal.

Tilgangskriterier for IPD-deling

Upon request to uicec@imibic.org

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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