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

Phase 1

• Conditions: Subjects with life-threatening COVID-19 symptoms; MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001644-25-ES
• Lead Sponsor: Acerta Pharma B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-14
• Study Completion: 2020-11-15
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 177

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 infection with 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.Able to swallow capsules or receive delivery of emptied capsule via a NG or an enteral feeding tube
5.Willing to follow contraception guidelines

For Part 2 Intensive Care Unit (ICU 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 infection with SARS-CoV-2 per 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.Able to swallow capsules or receive delivery of emptied capsule via a NG or an enteral feeding tube
5.Willing to follow contraception guidelines
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 128

Exclusion Criteria

For Part 1 and Part 2 (All Subjects):
1. Pregnant or breast feeding
2. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARS-CoV-2)
3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 x upper limit of normal (ULN) detected within 24 hours at screening (per local lab)
4. 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.
For Part 1:
1.Respiratory failure before randomization
2.Known medical resuscitation within 14 days of randomization

For Part 2:
1.Randomization to Part 1

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified