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

Malignant Solid Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05135650
• Other study ID #: RG1121602
• Secondary ID: NCI-2021-0594910
• Status: Terminated
• Phase: Phase 1
• Start date: January 25, 2022
• Est. completion date: January 10, 2023

Study information

• Verified date: June 2023
• Source: Fred Hutchinson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: January 10, 2023
• Est. primary completion date: October 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Questionnaire Administration
Ancillary studies

Biological:
• Sotrovimab
Given IV

Procedure:
• Biospecimen Collection
Undergo blood and nasal swab sample collection

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	National Marrow Donor Program, Vir Biotechnology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Half-life of sotrovimab (VIR-7831) post-transplant	Will use descriptive statistics. Levels of VIR-7831 can be measured using an idiotypic antibody assay that is not affected by COVID-19 infection or vaccination.	Up to 24 weeks
Primary	Neutralizing antibody titers	Will be calculated by a one-phase exponential decay model. Will compare fold-changes in antibody titers by normalizing to pre-transplant levels for each subject.	Up to 24 weeks
Secondary	Half-life of VIR-7831 in matched versus mis-matched donors	Comparisons will be tested using a t-test.	Up to 24 weeks
Secondary	Half-life of VIR-7831 in autologous vs allogeneic HCT	Comparisons will be tested using a t-test.	Up to 24 weeks
Secondary	Half-life of VIR-7831 in patients with diarrhea vs no diarrhea	Comparisons will be tested using a t-test.	Up to 24 weeks
Secondary	Half-life of VIR-7831 in patients with and without graft versus host disease	Comparisons will be tested using a t-test.	Up to 24 weeks
Secondary	Frequency of breakthrough SARS-CoV-2 acquisition	Will monitor for breakthrough SARS-CoV-2 infection by polymerase chain reaction of fluid collected by nasal swabs.	Up to 24 weeks
Secondary	Antibody levels from serum/plasma	Will compare antibody levels from serum/plasma collected by venipuncture versus self-collected using a TASSO device and fluid from nasal swabs.	At 12, 16, 20 and 24 weeks
Secondary	Anti-drug antibody levels from serum/plasma	Will monitor for anti-drug antibody levels from serum/plasma collected by venipuncture versus self-collected using a TASSO device	At 12, 16, 20 and 24 weeks (and week 40 if positive at week 24)
Secondary	Incidence of adverse events	Will monitor safety with routine labs as part of standard post-transplant care.	Up to 40 weeks