Pharmacokinetics of Sotrovimab 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