A Phase 1 interventional study of Questionnaire Administration and Sotrovimab in COVID-19 Infection, Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, sponsored by Fred Hutchinson Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by Fred Hutchinson Cancer Center · Phase 1, Interventional, and Prevention
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 20 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pregnant or breastfeeding (this population is generally not cleared for transplant)
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.
Other: Questionnaire Administration · Biological: Sotrovimab · Procedure: Biospecimen Collection
Ancillary studies
Given IV
Also known as: 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
Undergo blood and nasal swab sample collection
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Half-life of Sotrovimab (VIR-7831) Post-transplant
Will use descriptive statistics of model estimation from population pharmacokinetic model. 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
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. Data analysis was not performed.
Time frame: Up to 24 weeks
Half-life of VIR-7831 in Matched vs Mismatched Donors
Comparisons will be tested using a t-test. 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
Half-life of VIR-7831 in Autologous vs Allogeneic HCT
Comparisons will be tested using a t-test. 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
VIR-7831 Exposure in Patients With Diarrhea vs no Diarrhea
Sotrovimab exposure to be measured as the area under curve (AUC) of sotrovimab concentration over time in model simulation. Comparisons will be tested using a t-test.
Time frame: Up to 24 weeks
VIR-7831 Exposure in Patients With and Without Graft Versus Host Disease
Sotrovimab exposure to be measured as the area under curve (AUC) of sotrovimab concentration over time. Comparisons will be tested using a t-test.
Time frame: Up to 24 weeks
Number of Participants With Breakthrough SARS-CoV-2 Acquisition
Will monitor for breakthrough SARS-CoV-2 infection by polymerase chain reaction of fluid collected by nasal swabs.
Time frame: Up to 24 weeks
Antibody Clearance Rate 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. To do this, will compare rate of antibody clearance on average in study population pharmacokinetic model.
Time frame: Up to 24 weeks
Number of Participants With Presence of Anti-drug Antibodies From Serum/Plasma
Will monitor for presence of anti-drug antibodies from serum/plasma collected by venipuncture versus self-collected using a TASSO device. Samples were considered either positive or negative for presence of anti-drug antibodies.
Time frame: At 4 and 24 weeks
Number of Participants With Adverse Events
Will monitor safety with routine labs as part of standard post-transplant care.
Time frame: Up to 40 weeks
| Milestone | Sotrovimab |
|---|---|
| Started | 20 |
| Completed | 17 |
| Not completed | 3 |
Will use descriptive statistics of model estimation from population pharmacokinetic model. Levels of VIR-7831 can be measured using an idiotypic antibody assay that is not affected by COVID-19 infection or vaccination.
| Days | Sotrovimab |
|---|---|
| Half-life of Sotrovimab (VIR-7831) Post-transplant | 51.14 ± 18.59 |
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. Data analysis was not performed.
No measurements were reported for this outcome.
Comparisons will be tested using a t-test. Levels of VIR-7831 can be measured using an idiotypic antibody assay that is not affected by COVID-19 infection or vaccination.
No measurements were reported for this outcome.
Comparisons will be tested using a t-test. Levels of VIR-7831 can be measured using an idiotypic antibody assay that is not affected by COVID-19 infection or vaccination.
| Days | Sotrovimab |
|---|---|
| Half-life in autologous participants | 63.9 (51.5 to 75.0) |
| Half-life in allogeneic participants | 49.4 (19.5 to 69.7) |
Sotrovimab exposure to be measured as the area under curve (AUC) of sotrovimab concentration over time in model simulation. Comparisons will be tested using a t-test.
| (AUC) micrograms x day/mL | Sotrovimab |
|---|---|
| Allogeneic HCT with diarrhea | 2027.48 ± 348.84 |
| Allogeneic HCT without diarrhea | 3613.94 ± 392.81 |
| Autologous HCT without diarrhea | 4146.8 ± 397.57 |
Sotrovimab exposure to be measured as the area under curve (AUC) of sotrovimab concentration over time. Comparisons will be tested using a t-test.
| (AUC) micrograms x day/mL | Sotrovimab |
|---|---|
| Allogeneic HCT with lower GI GVHD | 1846.97 ± 315.84 |
| Allogeneic HCT without lower GI GVHD | 3613.94 ± 392.81 |
| Autologous HCT without lower GI GVHD | 4146.8 ± 397.57 |
Will monitor for breakthrough SARS-CoV-2 infection by polymerase chain reaction of fluid collected by nasal swabs.
| Participants | Sotrovimab |
|---|---|
| Number of Participants With Breakthrough SARS-CoV-2 Acquisition | 3 |
Will compare antibody levels from serum/plasma collected by venipuncture versus self-collected using a TASSO device and fluid from nasal swabs. To do this, will compare rate of antibody clearance on average in study population pharmacokinetic model.
| L/day | Sotrovimab |
|---|---|
| Elimination clearance in autologous HCT participants | 0.1074 ± 0.0141 |
| Elimination clearance in allogeneic HCT participants | 0.1462 ± 0.0479 |
Will monitor for presence of anti-drug antibodies from serum/plasma collected by venipuncture versus self-collected using a TASSO device. Samples were considered either positive or negative for presence of anti-drug antibodies.
| Participants | Venipuncture | TASSO Device |
|---|---|---|
| Baseline with positive test results | 0 | — |
| Week 4 with positive test results | 0 | — |
| Week 24 with positive test results | 0 | — |
Will monitor safety with routine labs as part of standard post-transplant care.
| Participants | Sotrovimab |
|---|---|
| Number of Participants With Adverse Events | 4 |
Collected over 10 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sotrovimab | 1/20 (5%) | 1/20 (5%) | 3/20 (15%) |
| Event | Sotrovimab |
|---|---|
| DeathGastrointestinal disorders | 1/20 |
| Event | Sotrovimab |
|---|---|
| Hypertension stage 2Cardiac disorders | 2/20 |
| TinglingInjury, poisoning and procedural complications | 1/20 |
| Age, Categorical(Participants) | Sotrovimab |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 10 |
| Sex: Female, Male(Participants) | Sotrovimab |
|---|---|
| Female | 6 |
| Male | 14 |
| Race (NIH/OMB)(Participants) | Sotrovimab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 0 |
| White | 18 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Diagnosis(Participants) | Sotrovimab |
|---|---|
| Acute leukemia | 5 |
| T-LGL | 1 |
| MDS | 5 |
| MPN (CMML, MF) | 3 |
| Lymphoma | 3 |
| Multiple myeloma | 3 |
| Conditioning regimen(Participants) | Sotrovimab |
|---|---|
| Mel | 3 |
| Flu/Mel | 2 |
| Flu/Treo | 1 |
| Flu/TBI | 3 |
| Bu/Cy | 1 |
| Flu/Mel/TBI | 5 |
| Flu/Cy/TBI | 1 |
| Bu/Cy/Thiotepa | 1 |
| Bu/Cy/Thiotepa/Palifermin | 1 |
| Flu/Cy/Thiotepa/TBI | 1 |
| CLAG-M/TBI | 1 |
| Type of transplant(Participants) | Sotrovimab |
|---|---|
| Allogeneic matched unrelated | 8 |
| Allogeneic matched related | 4 |
| Allogeneic mismatched unrelated | 1 |
| Allogeneic cord blood | 2 |
| Autologous | 5 |
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Plan to share: No
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Fred Hutchinson Cancer Center