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Pilot Study of Single Dose Bevacizumab as Treatment for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 Patients (BEVACOR)

31. august 2021 oppdatert av: Maimónides Biomedical Research Institute of Córdoba
Our hypothesis is that treating ARDS caused by COVID-19 with bevacizumab improves mortality. This is a phase II, multi-centered, randomized, open label, two-armed clinical trial to study the safety and efficacy of bevacizumab in COVID-19 positive patients who consequently developed ARDS (acute respiratory distress syndrome) and who have previously received anti-viral and anti-inflammatory treatment.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The vascular endothelial growth factor (VEGF) improves vascular capillarity, which plays an important role in the uncontrolled inflammatory reaction that happens in ARDS. As opposed to this event, angiogenic therapy (like bevacizumab) is known to contribute to normal vascularization, relevant for regaining vascular permeability. Studies in animal models have shown that treating ARDS with anti-VEGF therapy is effective.

Studietype

Intervensjonell

Registrering (Faktiske)

21

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
    • Córdona
      • Córdoba, Córdona, 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 90 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Age equal or over 18 and under 90 years old.
  • Confirmed COVID-19 positive diagnostic through PCR.
  • Radiological image compatible with non-cardiogenic bilateral pleuropulmonary exudate.
  • Patient has received anti-viral and anti-inflammatory therapy.

  • Present any of the following clinical-functional criteria:

    1. Respiratory distress: Tachypnea> 30 breaths / minute
    2. Partial arterial oxygen pressure (PaO2) / Fraction of inspiration (FiO2) ≤ 300 mmHg
  • Signed informed consent, directly or delegated.

Exclusion Criteria:

  • Severe liver dysfunction (Child Pugh ≥ 3 or AST> 5 times normal)
  • Severe renal dysfunction with glomerular filtration <30 mL / minute or under treatment with hemodialysis or peritoneal dialysis.
  • Poorly controlled hypertension (BPs> 160 mmHg or TAd <100 mmHg) or having a history previous hypertensive crisis or hypertensive encephalopathy.
  • History of poorly controlled heart disease with a NYHA> 2.
  • History of thrombosis in the previous 6 months.
  • Signs of active bleeding.
  • Open wounds, gastrointestinal perforation.
  • Diagnosis of thrombophilic diseases or hemorrhagic diathesis.
  • Active viral hepatitis or HIV not properly treated.
  • Intolerance or allergy to bevacizumab 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: BEVACIZUMAB
Patients will receive best available treatment (BAT) for COVID-19 plus single dose bevacizumab calculated as 7,5 mg/kg diluted in 250cc of saline solution during 90 minutes.
Legemiddel: Bevacizumab
Patients will receive best available treatment (BAT) for COVID-19 plus a single dose of bevacizumab calculated as 7,5 mg/kg diluted in 250cc of saline solution during 90 minutes.
Aktiv komparator: BEST AVAILABLE TREATMENT
Patients will receive best available treatment for COVID-19.
Legemiddel: BAT
Patients will receive best available treatment for COVID-19.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mortality
Tidsramme: After 28 days
Mortality
After 28 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
PaO2/FiO2
Tidsramme: 6 hours before bevacizumab administration and 24 hours,72 hours,7 days,14 days and 28 days after.
Ratio calculation
6 hours before bevacizumab administration and 24 hours,72 hours,7 days,14 days and 28 days after.
Clinical improvement according to scale recommended by WHO for COVID19
Tidsramme: 24 hours, 72 hours, 7 days, 14 days and 28 days after treatment.
Clinical improvement according to WHO scale (World Health Organization) for COVID19 which goes from 1 to 7 points.
24 hours, 72 hours, 7 days, 14 days and 28 days after treatment.
Time to clinical improvement as stated in the National Early Warning Score 2 (NEWS)
Tidsramme: From randomization until improvement of 2 points in the scale or until hospital discharge, whatever happens first, assessed up to 28 days.
NEWS assesses clinical risk on a scale of 1 (low) to 8 (high)
From randomization until improvement of 2 points in the scale or until hospital discharge, whatever happens first, assessed up to 28 days.
Time to improvement of oxygenation
Tidsramme: From randomization until outcome event assessed up to 28 days.
Improvement shown during, at least, 48 hours.
From randomization until outcome event assessed up to 28 days.
Time to improvement of Sp2/O2 ratio regarding the worst Sp2/O2 ratio obtained before bevacizumab treatment.
Tidsramme: From randomization until first documented Sp2/O2 ratio improvement, assessed up to 28 days.
Time to improvement of Sp2/O2 ratio regarding the worst Sp2/O2 ratio obtained before bevacizumab treatment
From randomization until first documented Sp2/O2 ratio improvement, assessed up to 28 days.
Time to absence of oxygen need to maintain a saturation equal or over 93%
Tidsramme: From randomization until patient doesn't need oxygen to mantain 93% saturation, assessed up to 28 days.
Time to absence of oxygen need to maintain a saturation equal or over 93%
From randomization until patient doesn't need oxygen to mantain 93% saturation, assessed up to 28 days.
Favorable radiological evaluation.
Tidsramme: From randomization until first documented radiology improvement, assessed up to 28 days.
Dictated by 3 radiologists.
From randomization until first documented radiology improvement, assessed up to 28 days.

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

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)

1. september 2020

Primær fullføring (Faktiske)

31. august 2021

Studiet fullført (Faktiske)

31. august 2021

Datoer for studieregistrering

Først innsendt

6. juli 2021

Først innsendt som oppfylte QC-kriteriene

7. juli 2021

Først lagt ut (Faktiske)

8. juli 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. september 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. august 2021

Sist bekreftet

1. august 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • BEVACOR

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-delingstidsramme

When study is published.

Tilgangskriterier for IPD-deling

Send request to access.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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