Subjects with life-threatening COVID-19 symptoms MedDRA version: 20.0 Level: LLT Classification code 10051905 Term: Coronavirus infection System Organ Class: 100000004862
Conditions
Sponsors
Acerta Pharma B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For Part 1 (Randomized cohort): 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) 2. Men and women =18 years of age at the time of signing the informed consent form 3. Confirmed COVID-19 infection 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 3 weeks of study entry) with suspected pneumonia requiring hospitalization and oxygen saturation 300 ng/mL for men and > 150 ng/mL for women (b) C-reactive protein (CRP) = 10 mg/L (c) D-dimer > 1 mg/L (d) Absolute lymphocyte count =65 years) yes F.1.3.1 Number of subjects for this age range 128
Exclusion criteria
Exclusion criteria: For Part 1 and Part 2 (All Subjects): 1. Pregnant or breast feeding 2. Are not committed to aggressive management. For example, the subject’s family or primary physician are unwilling to place the subject on mechanical ventilation or an advanced directive to withhold life support, with the exception of cardiopulmonary resuscitation, is present. 3. Suspected, uncontrolled active bacterial, fungal, viral, or other infection (besides COVID 19) 4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 x upper limit of normal (ULN) detected within 24 hours at screening (per local lab) 5. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, congestive heart failure (New York Heart Association [NYHA] Grade 3 or 4), or require home oxygen for a chronic lung disorder. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 6. Use of active systemic or inhaled corticosteroids. Subjects who stop active systemic or inhaled corticosteroids before the first dose of acalabrutinib will not be excluded. 7. Concomitant use of JAK, PI3K, or Btk (other than acalabrutinib) inhibitors with acalabrutinib. Subjects who stop JAK or PI3K inhibitors before the first dose of acalabrutinib will not be excluded. Use of other Btk inhibitors must be stopped 30 days before the first dose of acalabrutinib. For Part 1: 1. In ICU or on invasive mechanical ventilation or ECMO machine before randomization. 2. Known medical resuscitation within 14 days of randomization For Part 2: 1. Randomization to Part 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall objective of the study is to evaluate the efficacy of adding acalabrutinib to BSC for the treatment of COVID-19;Secondary Objective: To assess pharmacokinetics of acalabrutinib and its active metabolite in subjects with COVID-19 when administered with BSC ;Timepoint(s) of evaluation of this end point: Approximately 30 days;Primary end point(s): The primary endpoint is treatment failure rate, where treatment failure is defined as use of assisted ventilation or death. For the purpose of this study assisted ventilation is defined as noninvasive ventilation (eg, continuous positive airway pressure [CPAP] ventilation), invasive mechanical ventilation, or ECMO machine | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: approximately 30 days and for survival status approximately 90 days;Secondary end point(s): • Number of days alive free of assisted ventilation from randomization/enrollment to 30 days after randomization/enrollment • Number of days with assisted ventilator use from randomization/enrollment to 30 days after randomization/enrollment • Number of days hospitalized from randomization/enrollment to 30 days after randomization/enrollment • Number of days in ICU from randomization/enrollment to 30 days after randomization/enrollment • Number of days alive outside of hospital from randomization/enrollment to 30 days after randomization/enrollment • Number of days alive outside of hospital from randomization/enrollment to 90 days after randomization/enrollment • Type, frequency, severity, and relationship to study treatment of any treatment-emergent adverse events (TEAEs) or abnormalities of laboratory tests, serious adverse events (SAEs), or adverse events (AEs) leading to discontinuation of study treatment. • Standard and appropriate pharmacokinetic parameters | — |
Countries
France, Germany, Italy, Spain, Sweden, United States
Contacts
Public ContactClinical Trial Call Center
Acerta Pharma B.V.
Outcome results
None listed