Clinical trial NCT05135650: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: COVID-19 Infection
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Marrow Donor Program
name: Vir Biotechnology, Inc.
First posted: 2021-11-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Half-life of Sotrovimab (VIR-7831) Post-transplant
timeFrame: Up to 24 weeks
measure: Neutralizing Antibody Titers
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Half-life of VIR-7831 in Matched vs Mismatched Donors
timeFrame: Up to 24 weeks
measure: Half-life of VIR-7831 in Autologous vs Allogeneic HCT
timeFrame: Up to 24 weeks
measure: VIR-7831 Exposure in Patients With Diarrhea vs no Diarrhea
timeFrame: Up to 24 weeks
measure: VIR-7831 Exposure in Patients With and Without Graft Versus Host Disease
timeFrame: Up to 24 weeks
measure: Number of Participants With Breakthrough SARS-CoV-2 Acquisition
timeFrame: Up to 24 weeks
measure: Antibody Clearance Rate From Serum/Plasma
timeFrame: Up to 24 weeks
measure: Number of Participants With Presence of Anti-drug Antibodies From Serum/Plasma
timeFrame: At 4 and 24 weeks
measure: Number of Participants With Adverse Events
timeFrame: Up to 40 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Alpana Waghmare
role: PRINCIPAL_INVESTIGATOR
References: