Acalabrutinib Study With Best Supportive Care in Participants Hospitalized With COVID-19
NCT ID: NCT04497948
Last Updated: 2021-11-17
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
9 participants
INTERVENTIONAL
2020-09-21
2020-11-18
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
Single Arm
Acalabrutinib
Acalabrutinib (CALQUENCE®) is a covalent BTK inhibitor
Interventions
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Acalabrutinib
Acalabrutinib (CALQUENCE®) is a covalent BTK inhibitor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants who are hospitalized with coronavirus (SARS-CoV-2) infection, confirmed by PCR test or other commercial or public health assay in any specimen, as documented by either of the following:
1. PCR positive in sample collected \< 72 hours prior to first dose, OR
2. PCR positive in sample collected ≥ 72 hours prior to first dose (but no more than 14 days prior to first dose), documented inability to obtain a repeat sample (eg, due to lack of testing supplies, limited testing capacity, results taking \> 24 hours, etc), AND progressive disease suggestive of ongoing SARS-CoV-2 infection 3 Evidence of respiratory failure attributable to COVID-19 pneumonia (documented radiographically) before enrollment 4 Nasogastric tube or other types of oral or percutaneous gastric feeding tube; placement must be radiographically confirmed and expected to remain in place, as judged by the investigator, for a minimum of 3 days after study enrolment.
5 Has received treatment with PPIs (eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole) for a minimum of 24 hours immediately prior to enrollment; any PPI will be permitted, provided it meets the minimum equivalent daily dose of 20 mg rabeprazole.
Exclusion Criteria
2. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
3. Current refractory nausea and vomiting, malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
4. Received BTK inhibitor within 7 days before enrollment.
5. Requires or is receiving anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon) within 7 days prior to enrollment. Other anticoagulants are permitted.
6. Participants on dual antiplatelet and therapeutic anticoagulant therapy (eg, aspirin and therapeutic doses of low molecular weight heparin are not allowed; however, aspirin and prophylactic/ low doses of low-molecular-weight heprin are allowed).
18 Years
100 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Acerta Pharma BV
INDUSTRY
Responsible Party
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Locations
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Research Site
Porto Alegre, , Brazil
Research Site
Ribeirão Preto, , Brazil
Research Site
São Paulo, , Brazil
Research Site
São Paulo, , Brazil
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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D822FC00005
Identifier Type: -
Identifier Source: org_study_id