NCT05135650

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

Pharmacokinetics of a SARS-CoV-2 Monoclonal Antibody in Hematopoietic Stem Cell Transplant Recipients (COVIDMAB)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Questionnaire Administration	Ancillary studies
BIOLOGICAL	Sotrovimab	Given IV
PROCEDURE	Biospecimen Collection	Undergo blood and nasal swab sample collection

Timeline

• Start date: 2022-01-25
• Primary completion: 2022-10-18
• Completion: 2023-01-10
• First posted: 2021-11-26
• Last updated: 2025-02-13
• Results posted: 2025-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study