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

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ClinicalTrials.gov Identifier: NCT05135650
Recruitment Status : Suspended (Enrollment temporarily on hold for amendment submission)
First Posted : November 26, 2021
Last Update Posted : January 26, 2023
Sponsor:
Collaborators:
National Marrow Donor Program
Vir Biotechnology, Inc.
Information provided by (Responsible Party):
Fred Hutchinson Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Infection Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Other: Questionnaire Administration Biological: Sotrovimab Phase 1

Detailed Description:

OUTLINE:

Patients receive sotrovimab intravenously (IV) over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning.

After completion of study treatment, patients are followed up for 24 weeks.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pharmacokinetics of a SARS-CoV-2 Monoclonal Antibody in Hematopoietic Stem Cell Transplant Recipients (COVIDMAB)
Actual Study Start Date : January 25, 2022
Estimated Primary Completion Date : January 15, 2024
Estimated Study Completion Date : January 15, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Sotrovimab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Prevention (Sotrovimab)
Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Half-life of sotrovimab (VIR-7831) post-transplant [ Time Frame: Up to 24 weeks ]
    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.

  2. Neutralizing antibody titers [ Time Frame: Up to 24 weeks ]
    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 :
  1. Half-life of VIR-7831 in matched versus mis-matched donors [ Time Frame: Up to 24 weeks ]
    Comparisons will be tested using a t-test.

  2. Half-life of VIR-7831 in autologous vs allogeneic HCT [ Time Frame: Up to 24 weeks ]
    Comparisons will be tested using a t-test.

  3. Half-life of VIR-7831 in patients with diarrhea vs no diarrhea [ Time Frame: Up to 24 weeks ]
    Comparisons will be tested using a t-test.

  4. Half-life of VIR-7831 in patients with and without graft versus host disease [ Time Frame: Up to 24 weeks ]
    Comparisons will be tested using a t-test.

  5. Frequency of breakthrough SARS-CoV-2 acquisition [ Time Frame: Up to 24 weeks ]
    Will monitor for breakthrough SARS-CoV-2 infection by polymerase chain reaction of fluid collected by nasal swabs.

  6. Antibody levels from serum/plasma [ Time Frame: At 12, 16, 20 and 24 weeks ]
    Will compare antibody levels from serum/plasma collected by venipuncture versus self-collected using a TASSO device and fluid from nasal swabs.

  7. Anti-drug antibody levels from serum/plasma [ Time Frame: At 12, 16, 20 and 24 weeks (and week 40 if positive at week 24) ]
    Will monitor for anti-drug antibody levels from serum/plasma collected by venipuncture versus self-collected using a TASSO device

  8. Incidence of adverse events [ Time Frame: Up to 40 weeks ]
    Will monitor safety with routine labs as part of standard post-transplant care.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05135650


Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Center
National Marrow Donor Program
Vir Biotechnology, Inc.
Investigators
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Principal Investigator: Alpana Waghmare Fred Hutch/University of Washington Cancer Consortium
More Information
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Responsible Party: Fred Hutchinson Cancer Center
ClinicalTrials.gov Identifier: NCT05135650    
Other Study ID Numbers: RG1121602
NCI-2021-05949 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
10691 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Posted: November 26, 2021    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Neoplasms
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents, Immunological
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents