Fred Hutchinson Cancer Center
This phase I trial studies the process by which sotrovimab is absorbed, distributed, metabolized, and eliminated by the body (pharmacokinetics) in hematopoietic stem cell transplant recipients. Sotrovimab is a monoclonal antibody that may target and bind to a specific protein on SARS-CoV-2 and block its viral attachment and entry into human cells. This may slow the progression of the disease and accelerate recovery, and may potentially provide temporary protection against infection with SARS-CoV-2 in hematopoietic stem cell transplant recipients.
COVID-19 Infection
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Questionnaire Administration
Sotrovimab
Biospecimen Collection
Phase 1
OUTLINE: Patients receive sotrovimab intravenously (IV) over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients also undergo blood and nasal swab sample collection throughout the trial. After completion of study treatment, patients are followed up for 24 weeks.}}
Study Type : | Interventional |
Estimated Enrollment : | 20 participants |
Masking : | None (Open Label) |
Primary Purpose : | Prevention |
Official Title : | Pharmacokinetics of a SARS-CoV-2 Monoclonal Antibody in Hematopoietic Stem Cell Transplant Recipients (COVIDMAB) |
Actual Study Start Date : | January 25, 2022 |
Estimated Primary Completion Date : | October 18, 2022 |
Estimated Study Completion Date : | January 10, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Prevention (Sotrovimab) Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients also undergo blood and nasal swab sample collection throughout the trial. |
Other: Questionnaire Administration Biological: Sotrovimab Procedure: Biospecimen Collection |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109