Phase 2
Completed N=62
Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19.
Source: ClinicalTrials.gov NCT04380688 ↗Enrolled (actual)
62
Serious AEs
16.1%
Results posted
Sep 2021
Primary outcomePrimary: Number of Participants With Adverse Events and Serious Adverse Events — 17; 15; 4; 6 Participants
Summary
CALAVI US 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 Number of Participants With Adverse Events and Serious Adverse Events |
17; 15; 4; 6 | — |
| PRIMARY Percentage of Participants Alive and Free of Respiratory Failure at Day 28 |
80.6; 83.9 | — |
| SECONDARY Percentage of Participants Alive and Free of Respiratory Failure at Day 14 |
80.6; 87.1 | — |
| SECONDARY Percent Change From Baseline in C-reactive Protein. |
-41.08; -26.74; -72.05; -49.55; -75.72; -40.53 | — |
| SECONDARY Percent Change From Baseline in Ferritin |
-15.25; -7.38; -29.67; -17.93; -36.59; -9.67 | — |
| SECONDARY Percent Change From Baseline in Absolute Lymphocyte Count |
54.75; 34.66; 28.18; 76.86; 46.22; 102.80 | — |
| SECONDARY Overall Survival |
NA; NA | — |
| SECONDARY Percentage of Participants Alive and Discharged From ICU |
83.9; 87.1; 83.9; 87.1 | — |
| 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 |
26.2; 24.6 | — |
| SECONDARY Number of Days With Respiratory Failure |
1.8; 3.4 | — |
| SECONDARY Number of Days Hospitalized |
7.6; 9.0 | — |
| SECONDARY Number of Days in ICU |
4.4; 7.0 | — |
| SECONDARY Number of Days Alive Outside of Hospital |
75.3; 72.7 | — |
| SECONDARY Number of Days Alive Outside of Hospital |
75.3; 72.7 | — |
| SECONDARY Percent Change From Baseline in Oxygenation Index |
14.24; 13.51; 40.25; 18.71; 18.41; 28.73 | — |
| SECONDARY Time From Randomization to Clinical Improvement of at Least 2 Points on a 9-point Category Ordinal Scale |
6.00; 7.00 | — |
| SECONDARY Pharmacokinetics of Acalabrutinib |
6.258; 26.683; 210.858; 124.143; 33.714; 165.080 | — |
| SECONDARY Pharmacokinetics of ACP-5862 |
53.818; 58.959; 293.606; 273.528; 178.575; 582.180 | — |
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 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 the time of screening due to COVID-19 pneumonia that impedes the ability to swallow pills, or in the opinion of the treating physician, the subject is likely to require mechanical ventilation within the immediate 24 hours and therefore unable to swallow pills.
- 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), and/or 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) Exception: AST and/or ALT ≤5 × ULN if considered due to underlying COVID-19 disease, but cannot be associated with concurrent elevated bilirubin (≤2 × ULN).
- 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).
Data sourced from ClinicalTrials.gov (NCT04380688). 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.