Phase 2
Completed N=177
Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19.
Source: ClinicalTrials.gov NCT04346199 ↗Enrolled (actual)
177
Serious AEs
5.1%
Results posted
Sep 2021
Primary outcomePrimary: Percentage of Participants Alive and Free of Respiratory Failure at Day 14 — 83.1; 90.9 Percentage of participants
Summary
CALAVI will investigate the safety, efficacy and pharmacokinetics of acalabrutinib together with Best Supportive Care in the treatment of COVID-19.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Alive and Free of Respiratory Failure at Day 14 |
83.1; 90.9 | — |
| SECONDARY Number of Participants With Adverse Events and Serious Adverse Events |
43; 37; 7; 2 | — |
| SECONDARY Percentage of Participants Alive and Free of Respiratory Failure at Day 28 |
84.3; 88.6 | — |
| SECONDARY Percent Change From Baseline in C-reactive Protein. |
-15.06; -15.25; -12.48; -41.07; -45.71; -23.41 | — |
| SECONDARY Percent Change From Baseline in Ferritin |
9.84; 6.49; 12.92; -12.76; -8.93; -8.79 | — |
| SECONDARY Percent Change From Baseline in Absolute Lymphocyte Count |
31.74; 36.82; 55.79; 87.25; 51.72; 79.33 | — |
| SECONDARY Overall Survival |
NA; NA | — |
| SECONDARY Percentage of Participants Alive and Discharged From ICU |
78.7; 89.8; 83.1; 87.5 | — |
| SECONDARY Time From Randomization to First Occurrence of Respiratory Failure or Death on Study Due to Any Cause |
NA; NA | — |
| SECONDARY Number of Days Alive and Free of Respiratory Failure |
24.8; 25.3 | — |
| SECONDARY Number of Days With Respiratory Failure |
3.2; 2.7 | — |
| SECONDARY Number of Days Hospitalized |
12.2; 10.4 | — |
| SECONDARY Number of Days in ICU |
10.4; 9.7 | — |
| SECONDARY Number of Days Alive Outside of Hospital |
66.8; 71.3 | — |
| SECONDARY Number of Days Alive Outside of Hospital |
66.8; 71.3 | — |
| SECONDARY Percent Change From Baseline in Oxygenation Index |
11.65; 12.20; 23.94; 33.09; 30.58; 54.51 | — |
| SECONDARY Time From Randomization to Clinical Improvement of at Least 2 Points on a 9-point Category Ordinal Scale |
10.00; 10.00 | — |
| SECONDARY Pharmacokinetics of Acalabrutinib |
15.359; 54.580; 56.120; 90.173; 36.841; 23.551 | — |
| SECONDARY Pharmacokinetics of ACP-5862 |
71.526; 125.332; 144.784; 213.370; 154.437; 113.769 | — |
Eligibility Criteria
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 (WHO) criteria (including positive RT-PCR nucleic acid test of any specimen [eg, respiratory, blood, urine, stool, or other bodily fluid]) within 4 days of randomization
- 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
- 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 within 24 hours at screening (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 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug).
- 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
- Received oral antirejection or immunomodulatory drugs (eg, anticytokines, Btk inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before randomization on study
Data sourced from ClinicalTrials.gov (NCT04346199). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.