Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Fred Hutchinson Cancer Center
With
National Marrow Donor Program
Vir Biotechnology, Inc.
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients (or legally authorized representative if applicable) must be capable of understanding and providing a written informed consent
Patients must be at least 18 years of age, of any gender, race, or ethnicity
Patients must be undergoing HCT (any donor or stem cell source including autologous or cord blood)
History of prior transplants are permitted
History of COVID-19, history of vaccination for SARS-CoV-2, positive polymerase chain reaction (PCR) of a respiratory specimen for SARS-CoV-2 as long as it is not within four weeks from conditioning, or seropositivity for SARS-CoV-2 are permitted
History of SARS-CoV-2 infection or vaccination of the donor are permitted.
Post-enrollment vaccination is anticipated and permitted
Administration of intravenous immunoglobulin therapy (IVIG) before or during the study is permitted
You may not be if
Signs or symptoms of uncontrolled, active infection
Positive PCR result for SARS-CoV-2 within four weeks of scheduled conditioning
Pregnant or breastfeeding (this population is generally not cleared for transplant)
* Pregnancy test is obtained as part of pre-transplant evaluation in women of child-bearing potential at arrival to transplant and again within 7 days of conditioning and will be confirmed as negative by review of the chart
Previous anaphylaxis or severe hypersensitivity reaction, including angioedema, to a mAb
Previous reaction to a mAb that required medical attention
Participants of other clinical studies that preclude the use of other investigational compounds
Participants who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of the protocol or unlikely to survive to the end of study
Clareo Health | Pharmacokinetics of Sotrovimab as Pre-exposure Prophylaxis for COVID-19 in Hematopoietic Stem Cell Transplant Recipients, COVIDMAB Study
