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An Open-label, Multiple-dose Study of Acalabrutinib, Co Administered With a Proton-pump Inhibitor, in Participants Hospitalized With COVID-19

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Trial Profile

An Open-label, Multiple-dose Study of Acalabrutinib, Co Administered With a Proton-pump Inhibitor, in Participants Hospitalized With COVID-19

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 10 Nov 2021

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At a glance

  • Drugs Acalabrutinib (Primary) ; Dexlansoprazole; Esomeprazole; Lansoprazole; Omeprazole; Pantoprazole; Rabeprazole
  • Indications COVID-19 pneumonia; Respiratory insufficiency
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Acerta Pharma; AstraZeneca

    • Most Recent Events

    • 01 Dec 2020 Status changed from recruiting to discontinued due to data from the CALAVI Phase II trials for Acalabrutinib in patients hospitalized with COVID-19did not meet their primary efficacy endpoints. Based on this higher management made the decision to prematurely terminate the D822FC00005 PK study.
    • 26 Oct 2020 Treatment arm Acalabrutinib added to study protocol. Allocation changed from Non-Randomized to N/A. Eligibility criteria amended to include subjects from 18-100 years. Planned number of subjects also increased.
    • 26 Oct 2020 Planned number of patients changed from 20 to 48.

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