Pharmacokinetics of Sotrovimab as Pre-exposure Prophylaxis for COVID-19 in Hematopoietic Stem Cell Transplant Recipients, COVIDMAB Study

Inclusion Criteria:

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

Exclusion Criteria:

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