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

NCT05135650 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-02-13

Study results available
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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.

Conditions

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

Interventions

OTHER

Questionnaire Administration

Ancillary studies

BIOLOGICAL

Sotrovimab

Given IV

PROCEDURE

Biospecimen Collection

Undergo blood and nasal swab sample collection

Sponsors & Collaborators

  • National Marrow Donor Program

    collaborator OTHER

  • Vir Biotechnology, Inc.

    collaborator INDUSTRY

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Alpana Waghmare · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-25
Primary Completion
2022-10-18
Completion
2023-01-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05135650 on ClinicalTrials.gov