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

Fred Hutchinson Cancer Center (FHCC)

Status and phase: Terminated; Phase 1

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm; COVID-19 Infection

Treatments: Other: Questionnaire Administration; Procedure: Biospecimen Collection; Biological: Sotrovimab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05135650

NCI-2021-05949 (Registry Identifier)

10691 (Registry Identifier)

RG1121602

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Prevention (Sotrovimab)

Experimental group

Description:

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.

Treatment:

Biological: Sotrovimab

Procedure: Biospecimen Collection

Other: Questionnaire Administration