Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19.

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    AstraZeneca
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Updated on 16 February 2024
See if I qualify
pneumonia
oximetry
covid-19
SARS
acalabrutinib
acute respiratory syndrome (sars)

Summary

CALAVI US will investigate the safety, efficacy and pharmacokinetics of acalabrutinib together with Best Supportive Care in the treatment of COVID-19.

Details
Condition Covid 19
Age 18years - 130years
Treatment Acalabrutinib
Clinical Study IdentifierNCT04380688
SponsorAstraZeneca
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Ability to understand the purpose and risks of the study and provide signed and dated informed consent or have a legal representative provide consent and authorization to use protected health information (in accordance with national and local patient privacy regulations)
Men and women 18 years of age at the time of signing the informed consent form
Confirmed infection with SARS-CoV-2 confirmed per World Health Organization criteria (including positive RT-PCR nucleic acid test)
COVID-19 pneumonia (documented radiographically) requiring hospitalization and oxygen saturation <94% on room air or requires supplemental oxygen
Able to swallow pills
Willing to follow contraception guidelines

Exclusion Criteria

Respiratory failure at time of screening due to COVID-19 Exception: Subjects are eligible if utilizing oxygen delivered by high-flow nasal cannula at flow rates <30 L/min and fraction of delivered oxygen <0.6, and in the opinion of the treating physician are unlikely to require mechanical ventilation within the immediate 24 hours
Known medical resuscitation within 14 days of randomization
Pregnant or breast feeding
Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARS-CoV-2)
Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin 3x upper limit of normal (ULN) and/or severe hepatic impairment detected during the screening period (per local lab)
Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll
Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 7 days before first dose of study drug) or inducer (within 14 days before first dose of study drug)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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