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

Primary Purpose

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

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Questionnaire Administration

Sotrovimab

Biospecimen Collection

About this trial

This is an interventional prevention trial for COVID-19 Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 in morphologic remission from their underlying disease prior to transplant (measurable residual disease permitted)
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, 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
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

Sites / Locations

Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prevention (Sotrovimab)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Half-life of VIR-7831 in matched versus mis-matched donors

Comparisons will be tested using a t-test.

Half-life of VIR-7831 in autologous vs allogeneic HCT

Comparisons will be tested using a t-test.

Half-life of VIR-7831 in patients with diarrhea vs no diarrhea

Comparisons will be tested using a t-test.

Half-life of VIR-7831 in patients with and without graft versus host disease

Comparisons will be tested using a t-test.

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.

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.

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

Incidence of adverse events

Will monitor safety with routine labs as part of standard post-transplant care.

Full Information

NCT ID

NCT05135650

First Posted

November 23, 2021

Last Updated

June 8, 2023

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Marrow Donor Program, Vir Biotechnology, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05135650

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Terminated

Why Stopped

Terminated due to FDA withdrawal of the emergency use authorization (EUA) for sotrovimab

Study Start Date

January 25, 2022 (Actual)

Primary Completion Date

October 18, 2022 (Actual)

Study Completion Date

January 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Marrow Donor Program, Vir Biotechnology, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prevention (Sotrovimab)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Ancillary studies

Intervention Type

Biological

Intervention Name(s)

Sotrovimab

Other Intervention Name(s)

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

Intervention Description

Given IV

Intervention Type

Procedure

Intervention Name(s)

Biospecimen Collection

Other Intervention Name(s)

Biological Sample Collection, Biospecimen Collected, Specimen Collection

Intervention Description

Undergo blood and nasal swab sample collection

Primary Outcome Measure Information:

Title

Half-life of sotrovimab (VIR-7831) post-transplant

Description

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.

Time Frame

Up to 24 weeks

Title

Neutralizing antibody titers

Description

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.

Time Frame

Up to 24 weeks

Secondary Outcome Measure Information:

Title

Half-life of VIR-7831 in matched versus mis-matched donors

Description

Comparisons will be tested using a t-test.

Time Frame

Up to 24 weeks

Title

Half-life of VIR-7831 in autologous vs allogeneic HCT

Description

Comparisons will be tested using a t-test.

Time Frame

Up to 24 weeks

Title

Half-life of VIR-7831 in patients with diarrhea vs no diarrhea

Description

Comparisons will be tested using a t-test.

Time Frame

Up to 24 weeks

Title

Half-life of VIR-7831 in patients with and without graft versus host disease

Description

Comparisons will be tested using a t-test.

Time Frame

Up to 24 weeks

Title

Frequency of breakthrough SARS-CoV-2 acquisition

Description

Will monitor for breakthrough SARS-CoV-2 infection by polymerase chain reaction of fluid collected by nasal swabs.

Time Frame

Up to 24 weeks

Title

Antibody levels from serum/plasma

Description

Will compare antibody levels from serum/plasma collected by venipuncture versus self-collected using a TASSO device and fluid from nasal swabs.

Time Frame

At 12, 16, 20 and 24 weeks

Title

Anti-drug antibody levels from serum/plasma

Description

Will monitor for anti-drug antibody levels from serum/plasma collected by venipuncture versus self-collected using a TASSO device

Time Frame

At 12, 16, 20 and 24 weeks (and week 40 if positive at week 24)

Title

Incidence of adverse events

Description

Will monitor safety with routine labs as part of standard post-transplant care.

Time Frame

Up to 40 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alpana Waghmare

Organizational Affiliation

Fred Hutch/University of Washington Cancer Consortium

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fred Hutch/University of Washington Cancer Consortium

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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