Study in Hospitalized COVID-19 patients with Acalabrutinib along with the Best Supportive Care versus Best Supportive Care
- Conditions
- Health Condition 1: J960- Acute respiratory failureHealth Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/06/026228
- Lead Sponsor
- Acerta Pharma BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Ability to understand the purpose and risks of the study and provide signed and dated informed consent.
2.Men and women >=18 years of age
3.SARS-CoV-2 confirmed per World Health Organization (WHO) criteria 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
COVID-19 Related Medical Conditions
1. Respiratory failure at the time of screening due to COVID-19 pneumonia.
2. Known medical resuscitation within 14 days of randomization.
3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigators judgment, precludes the subjects safe participation in and completion of the study
4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2).
5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
Medical Conditions
6. Not expected to survive 28 days given their pre-existing, uncorrectable medical condition.
7. Pregnant or breast feeding.
8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin >= 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C).
9. Absolute neutrophil count (ANC) < 500/μL at screening (per local laboratory).
10. Platelet count < 50,000/μL at screening (per local laboratory).
11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) Ã? mass (kg)/(72 Ã? creatinine mg/dL) multiply by 0.85 if female].
12.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 area allowed to enrol on study.
13.History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease.
14.Quadriplegia.
15.History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization.
16.Known active hepatitis B or C infection requiring therapy.
Prior/Concomitant Therapy:
17.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).
18.Requires treatment with proton-pump inhibitors.
19.Received oral antirejection or immunomodulatory drugs.
20.Active participation in other drug clinical trials or received treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization/enrolment.
21.Subjects at randomization who require inhaled corticosteroids or maintenance doses of more than 7.5 mg of prednisone or equivalent per day.
22.Requires or is receiving anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) within 7 days of first dose of acalabrutinib.
23.History of hypersensitivity (ie, allergic response) to active or inactive excipients of acalabrutinib or other Btk inhibitors.
24.Known cytoreductive chemotherapy treatment within 14 days of randomization.
25.Major surgery (as defined by the Investigator) within 4 weeks prior to randomization or still recovering from prior surgery.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method