A Study to Evaluate Acalabrutinib with Best Supportive Care in Participants Hospitalized with COVID-19 (Enrolling by Invitation Only)

Overview

About this study

The purpose of this study is to evaluate the 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 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).
  • Confirmed infection with SARS-CoV-2 per World Health Organization criteria (including positive nucleic acid test of any specimen [eg, respiratory, blood, urine, stool, or other bodily fluid]) within 7 days prior to enrollment.
  • Evidence of respiratory failure attributable to COVID-19 pneumonia (documented radiographically) before enrollment.
  • Nasogastric tube or other types of oral gastric feeding tube; placement must be radiographically confirmed and expected to be in place, as judged by the Investigator, for a minimum of 3 days. Percutaneous endoscopic gastrostomy tube will not be allowed.
  • Has received treatment with PPIs (e.g., 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:

  • 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.
  • In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
  • 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.
  • Received BTK inhibitor within 14 days before enrollment.
  • Requires or is receiving anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon) within 7 days prior to enrollment. Other anticoagulants are permitted.
  • Participants on dual antiplatelet and therapeutic anticoagulant therapy (e.g., aspirin and therapeutic doses of low molecular weight heparin).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Philippe Bauer, M.D., Ph.D.

Closed for enrollment

More information

Publications

Publications are currently not available
.

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