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

NCT ID: NCT05135650

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-25
• Study Completion Date: 2023-01-10

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Sotrovimab

Intervention Type: BIOLOGICAL

Given IV

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo blood and nasal swab sample collection

Interventions

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Sotrovimab

Given IV

Intervention Type: BIOLOGICAL

Biospecimen Collection

Undergo blood and nasal swab sample collection

Intervention Type: PROCEDURE

Other Intervention Names

Anti-SARS-CoV-2 Spike Protein Monoclonal Antibody VIR-7831; GSK 4182136; GSK-4182136; GSK4182136; VIR 7831; VIR-7831; VIR7831; Monoclonal antibodies against SARS-CoV-2: sotrovimab; Biological Sample Collection; Biospecimen Collected; Specimen Collection

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Marrow Donor Program

OTHER

Sponsor Role: collaborator

Vir Biotechnology, Inc.

INDUSTRY

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Alpana Waghmare

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alpana Waghmare

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2021-05949

Identifier Type: REGISTRY

Identifier Source: secondary_id

10691

Identifier Type: OTHER

Identifier Source: secondary_id

RG1121602

Identifier Type: -

Identifier Source: org_study_id