A PHASE 2, OPEN LABEL, RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OFACALABRUTINIB WITH BEST SUPPORTIVE CARE VERSUS BEST SUPPORTIVE CARE INSUBJECTS HOSPITALIZED WITH COVID-19

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 18

Inclusion Criteria

Subjects are eligible to be included in the study only if all of the criteria below apply.
1. 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).
Clinical Study Protocol - 3.0 AstraZeneca
Acalabrutinib - ACE-ID-201 (D822FC00001)
CONFIDENTIAL AND PROPRIETARY 26 of 88
2. Men and women ≥18 years of age at the time of signing the Informed Consent Form
(ICF).
3. SARS-CoV-2 confirmed per World Health Organization (WHO) criteria (including
positive nucleic acid test of any specimen [eg, respiratory, blood, urine, stool, or other
bodily fluid]) within 4 days of randomization.
4. COVID-19 pneumonia (documented radiographically) requiring hospitalization and
oxygen saturation <94% on room air or requires supplemental oxygen.
5. Able to swallow pills.
6. Willing to follow contraception guidelines (refer to Appendix F).

Exclusion Criteria

Subjects are excluded from the study if any of the criteria below apply.
COVID-19 Related Medical Conditions
1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory
failure) due to COVID-19 pneumonia.
2. Known medical resuscitation within 14 days of randomization.
3. Any serious medical condition or abnormality of clinical laboratory tests that, in the
Investigator´s judgment, precludes the subject’s safe participation in and completion of
the study.
4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides
infection with SARSCoV2).
5. In the opinion of the Investigator, progression to death is imminent and inevitable within
the next 24 hours, irrespective of the provision of treatments.
Medical Conditions
6. Not expected to survive 28 days given their preexisting, uncorrectable medical
condition, for example, subjects with, or suspected to have, the following conditions:
multiorgan failure, poorly controlled neoplasms; endstage cardiac disease; cardiac arrest
requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole
within past 30 days; endstage lung disease; endstage liver disease; or human
immunodeficiency virus/acquired immunodeficiency syndrome with known endstage
process.
7. Pregnant or breast feeding.
8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin
≥ 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh
class C; see Appendix G) detected within 24 hours at screening (per local laboratory).
9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory).
10. Platelet count < 50,000/µL at screening (per local laboratory).
11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault
formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female].
12. 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 on study.
13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home
oxygen in the setting of severe chronic respiratory disease.
14. Quadriplegia.
15. History of primary immunodeficiency, tuberculosis, progressive multifocal
leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or
received organ or bone marrow transplantation within 6 months of randomization.
16. Known active hepatitis B or C infection requiring therapy.
Prior/Concomitant Therapy
17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before
first dose of study drug) or inducer (within 7 days before first dose of study drug).
18. Requires treatment with proton-pump inhibitors (PPIs; eg, omeprazole, esomeprazole,
lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs
who switch to H2-receptor antagonists or antacids are eligible for enrollment in this
study.
19. Received oral anti rejection or immunomodulatory drugs (eg, anti-cytokines, Btk
inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before randomization.
20. Active participation in oth

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials