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

Purpose

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.

Conditions

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Other: Questionnaire Administration
    Ancillary studies
  • Biological: Sotrovimab
    Given IV
    Other 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
  • Procedure: Biospecimen Collection
    Undergo blood and nasal swab sample collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection

Recruiting Locations

More Details

NCT ID
NCT05135650
Status
Terminated
Sponsor
Fred Hutchinson Cancer Center

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.