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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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).

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

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

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available

Información adicional de contacto

Formulario de contacto para ensayos que no son sobre cáncer

Teléfono: 800-664-4542 (llamada gratis)

Preguntas de estudios clínicos para pacientes internacionales