Acalabrutinib Study With Best Supportive Care in Participants Hospitalized With COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Acalabrutinib
Intervention description: Acalabrutinib (CALQUENCE®) is a covalent BTK inhibitor
Intervention MeSH terms: Acalabrutinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Single group multi dose study. Participants to receive Acalabrutinib + PPI and Best Supportive Care.
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: 2019 novel coronavirus disease; Acalabrutinib; Btk inhibitor

Summary:

      Study D822FC00005 will investigate the Phamacokinetics, Safety and tolerability of
      Acalabrutinib suspension when delivered via a nasogastric tube and co-administered with a
      Proton Pump Inhibitor, in the treatment of COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant or legally authorized representative must be able to understand the
             purpose and risks of the study and provide written informed consent and authorization
             to use protected health information (in accordance with national and local patient
             privacy regulations).

          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:

                    1. Any serious and uncorrectable medical condition or abnormality of clinical
                       laboratory tests that, in the Investigator's judgment, precludes the
                       participant's safe participation in and completion of the study.

                    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).