A Phase 2, Open Label, Randomized Study of the Efficacy and Safety of Acalabrutinib With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19

JRCT ID: jRCT2031230751

Registered date:28/03/2024

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 05/07/2020
• Target sample size: 6
• Countries of recruitment: Argentina,Japan,Brazil,Japan,Chile,Japan,France,Japan,Germany,Japan,India,Japan,Italy,Japan,Mexico,Japan,Peru,Japan,Poland,Japan,Russian Federation,Japan,Republic of South Africa,Japan,Turkey,Japan
• Study type: Interventional
• Intervention(s): Acalabrutinib 100 mg bid x 10 days

Outcome(s)

Primary Outcome

Percentage of Participants Alive and Free of Respiratory Failure at Day 14 [ Time Frame: At Day 14 ]

Respiratory failure, is defined based on resource utilization of any of the following modalities: a) Endotracheal intubation and mechanical ventilation b) Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen 0.5 or more) c) Non-invasive positive pressure ventilation or continuous positive airway pressure d) Extracorporeal membrane oxygenation

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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 or more at the time of signing the informed consent form

3. 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

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

Exclude criteria

1. Respiratory failure at time of screening due to COVID-19

2. Known medical resuscitation within 14 days of randomization

3. Pregnant or breast feeding

4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARS-CoV-2)

5. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin 3x or more upper limit of normal (ULN) and/or severe hepatic impairment detected within 24 hours at screening (per local lab)

6. 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

7. 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).

8. 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

9. Received oral antirejection or immunomodulatory drugs (eg, anticytokines, Btk inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before randomization on study

Related Information

• Primary Sponsor: Hibi Kazushige
• Secondary ID(s): NCT04346199