Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-26 @ 10:09 PM
Study NCT ID:
NCT05135650
Status:
TERMINATED
Last Update Posted:
2025-02-13
First Post:
2021-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetics of Sotrovimab as Pre-exposure Prophylaxis for COVID-19 in Hematopoietic Stem Cell Transplant Recipients, COVIDMAB Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711967', 'term': 'sotrovimab'}, {'id': 'D013048', 'term': 'Specimen Handling'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'awaghmar@fredhutch.org', 'phone': '206-667-7329', 'title': 'Dr. Alpana Waghmare (Study Principal Investigator)', 'organization': 'Fred Hutch/University of Washington Cancer Consortium'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "Limitations due to small sample size: Relatively low precision in estimating covariate effects. Models/data presented focus on GI GVHD as cause of diarrhea; subgroup analysis couldn't be performed to examine whether different pretransplant preparative regimens were associated with increased mAb elimination. Did not perform covariate analysis on varying types of allogeneic HCT.\n\nStudy halted prematurely due to emergence of variants with reduced in vitro neutralization to sotrovimab."}}, 'adverseEventsModule': {'timeFrame': '10 months', 'eventGroups': [{'id': 'EG000', 'title': 'Sotrovimab', 'description': 'Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample, and nasal swab collections throughout course of trial.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 3, 'seriousNumAtRisk': 20, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Hypertension stage 2', 'notes': 'Occurred following infusion or day after infusion. Unknown if related to investigation product.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tingling', 'notes': 'Tingling of arms and chest during product infusion. Paused infusion and improved without additional intervention. Unknown if related to product infusion.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death', 'notes': 'Gastrointestinal hemorrhage is cause of death. Determined to not be related to investigation product.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Half-life of Sotrovimab (VIR-7831) Post-transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab', 'description': 'Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample, and nasal swab collections throughout course of trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.14', 'spread': '18.59', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 weeks', 'description': '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.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Neutralizing Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab', 'description': 'Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample, and nasal swab collections throughout course of trial.'}], 'timeFrame': 'Up to 24 weeks', '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. Data analysis was not performed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Neutralization assays were not performed, thus no data was collected.'}, {'type': 'SECONDARY', 'title': 'Half-life of VIR-7831 in Matched vs Mismatched Donors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab', 'description': 'Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample, and nasal swab collections throughout course of trial.'}], 'timeFrame': 'Up to 24 weeks', 'description': '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.', 'reportingStatus': 'POSTED', 'populationDescription': 'There was only 1 participant in the mismatched group, therefore, sample size was too small to calculate and compare mean or median half-lives between groups. Thus, half-life data was not collected on these groups.'}, {'type': 'SECONDARY', 'title': 'Half-life of VIR-7831 in Autologous vs Allogeneic HCT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab', 'description': 'Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample, and nasal swab collections throughout course of trial.'}], 'classes': [{'title': 'Half-life in autologous participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63.9', 'groupId': 'OG000', 'lowerLimit': '51.5', 'upperLimit': '75.0'}]}]}, {'title': 'Half-life in allogeneic participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49.4', 'groupId': 'OG000', 'lowerLimit': '19.5', 'upperLimit': '69.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 24 weeks', 'description': '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.', 'unitOfMeasure': 'Days', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Two different groups were analyzed based on transplant type. The number of participants in each subgroup will add up to the total number of participants analyzed.'}, {'type': 'SECONDARY', 'title': 'VIR-7831 Exposure in Patients With Diarrhea vs no Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab', 'description': 'Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample, and nasal swab collections throughout course of trial.'}], 'classes': [{'title': 'Allogeneic HCT with diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2027.48', 'spread': '348.84', 'groupId': 'OG000'}]}]}, {'title': 'Allogeneic HCT without diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3613.94', 'spread': '392.81', 'groupId': 'OG000'}]}]}, {'title': 'Autologous HCT without diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4146.8', 'spread': '397.57', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 weeks', 'description': '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.', 'unitOfMeasure': '(AUC) micrograms x day/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Three different groups were analyzed based on transplant type and presence of diarrhea. The number of patients in each subgroup will add up to the total number of patients analyzed.'}, {'type': 'SECONDARY', 'title': 'VIR-7831 Exposure in Patients With and Without Graft Versus Host Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab', 'description': 'Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample, and nasal swab collections throughout course of trial.'}], 'classes': [{'title': 'Allogeneic HCT with lower GI GVHD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1846.97', 'spread': '315.84', 'groupId': 'OG000'}]}]}, {'title': 'Allogeneic HCT without lower GI GVHD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3613.94', 'spread': '392.81', 'groupId': 'OG000'}]}]}, {'title': 'Autologous HCT without lower GI GVHD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4146.8', 'spread': '397.57', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 weeks', 'description': 'Sotrovimab exposure to be measured as the area under curve (AUC) of sotrovimab concentration over time. Comparisons will be tested using a t-test.', 'unitOfMeasure': '(AUC) micrograms x day/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Three different groups were analyzed based on transplant type and presence of lower GI GVHD. The number of patients in each subgroup will add up to the total number of patients analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Breakthrough SARS-CoV-2 Acquisition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab', 'description': 'Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample, and nasal swab collections throughout course of trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 weeks', 'description': 'Will monitor for breakthrough SARS-CoV-2 infection by polymerase chain reaction of fluid collected by nasal swabs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Antibody Clearance Rate From Serum/Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab', 'description': 'Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample, and nasal swab collections throughout course of trial.'}], 'classes': [{'title': 'Elimination clearance in autologous HCT participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1074', 'spread': '0.0141', 'groupId': 'OG000'}]}]}, {'title': 'Elimination clearance in allogeneic HCT participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1462', 'spread': '0.0479', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 weeks', 'description': '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.', 'unitOfMeasure': 'L/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only those participants with data available at the specified time points were analyzed. Due to early termination, we did not analyze TASSO samples or nasal swabs, hence there is no TASSO or nasal swab data to report.\n\nTwo different groups were analyzed based on transplant type. The number of patients in each subgroup will add up to the total number of patients analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Presence of Anti-drug Antibodies From Serum/Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Venipuncture', 'description': 'Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample via venipuncture, and nasal swab collections throughout course of trial.'}, {'id': 'OG001', 'title': 'TASSO Device', 'description': 'Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample via self-collected TASSO device, and nasal swab collections throughout course of trial.'}], 'classes': [{'title': 'Baseline with positive test results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 with positive test results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 with positive test results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 4 and 24 weeks', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only blood collected by venipuncture was assessed. Blood was rarely collected using the TASSO device due to participants declining TASSO use, sotrovimab deauthorization, and early study termination. Limited blood collection with TASSO device, premature study closure, and lack of funds prevented planned laboratory assays on blood collected with the TASSO device. Thus, no laboratory data is available from TASSO-collected blood and no analysis was performed. Further data collection is not planned.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab', 'description': 'Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample, and nasal swab collections throughout course of trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 40 weeks', 'description': 'Will monitor safety with routine labs as part of standard post-transplant care.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sotrovimab', 'description': 'Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample, and nasal swab collections throughout course of trial.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Sotrovimab', 'description': 'Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample, and nasal swab collections throughout course of trial.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosis', 'classes': [{'categories': [{'title': 'Acute leukemia', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'T-LGL', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'MDS', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'MPN (CMML, MF)', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Lymphoma', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Multiple myeloma', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Conditioning regimen', 'classes': [{'categories': [{'title': 'Mel', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Flu/Mel', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Flu/Treo', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Flu/TBI', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Bu/Cy', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Flu/Mel/TBI', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Flu/Cy/TBI', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Bu/Cy/Thiotepa', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Bu/Cy/Thiotepa/Palifermin', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Flu/Cy/Thiotepa/TBI', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'CLAG-M/TBI', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Conditioning regimens are determined by clinical teams. Data is collected through chart review. Abbreviations: Bu, busulfan; CLAG-M, cladribine + cytarabine + granulocyte colony-stimulating factor + mitoxantrone; CMML, chronic myelomonocytic leukemia; Cy, cyclophosphamide; Flu, fludarabine; MDS, myelodysplastic syndrome; Mel, melphalan; MF, myelofibrosis; MPN, myeloproliferative neoplasm; TBI, total body irradiation; T-LGL, T-cell large granular lymphocytic leukemia; Treo, treosulfan.', 'unitOfMeasure': 'Participants'}, {'title': 'Type of transplant', 'classes': [{'categories': [{'title': 'Allogeneic matched unrelated', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Allogeneic matched related', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Allogeneic mismatched unrelated', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Allogeneic cord blood', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Autologous', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-17', 'size': 694672, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-24T17:08', 'hasProtocol': True}, {'date': '2022-02-24', 'size': 1818862, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-06-08T14:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'Terminated due to FDA withdrawal of the emergency use authorization (EUA) for sotrovimab', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2021-11-23', 'resultsFirstSubmitDate': '2024-06-28', 'studyFirstSubmitQcDate': '2021-11-23', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-11', 'studyFirstPostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Half-life of Sotrovimab (VIR-7831) Post-transplant', 'timeFrame': 'Up to 24 weeks', 'description': '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.'}, {'measure': 'Neutralizing Antibody Titers', 'timeFrame': 'Up to 24 weeks', '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. Data analysis was not performed.'}], 'secondaryOutcomes': [{'measure': 'Half-life of VIR-7831 in Matched vs Mismatched Donors', 'timeFrame': 'Up to 24 weeks', 'description': '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.'}, {'measure': 'Half-life of VIR-7831 in Autologous vs Allogeneic HCT', 'timeFrame': 'Up to 24 weeks', 'description': '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.'}, {'measure': 'VIR-7831 Exposure in Patients With Diarrhea vs no Diarrhea', 'timeFrame': 'Up to 24 weeks', 'description': '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.'}, {'measure': 'VIR-7831 Exposure in Patients With and Without Graft Versus Host Disease', 'timeFrame': 'Up to 24 weeks', 'description': 'Sotrovimab exposure to be measured as the area under curve (AUC) of sotrovimab concentration over time. Comparisons will be tested using a t-test.'}, {'measure': 'Number of Participants With Breakthrough SARS-CoV-2 Acquisition', 'timeFrame': 'Up to 24 weeks', 'description': 'Will monitor for breakthrough SARS-CoV-2 infection by polymerase chain reaction of fluid collected by nasal swabs.'}, {'measure': 'Antibody Clearance Rate From Serum/Plasma', 'timeFrame': 'Up to 24 weeks', 'description': '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.'}, {'measure': 'Number of Participants With Presence of Anti-drug Antibodies From Serum/Plasma', 'timeFrame': 'At 4 and 24 weeks', 'description': '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.'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'Up to 40 weeks', 'description': 'Will monitor safety with routine labs as part of standard post-transplant care.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19 Infection', 'Hematopoietic and Lymphoid Cell Neoplasm', 'Malignant Solid Neoplasm']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'OUTLINE:\n\nPatients 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.\n\nAfter completion of study treatment, patients are followed up for 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients (or legally authorized representative if applicable) must be capable of understanding and providing a written informed consent\n* Patients must be at least 18 years of age, of any gender, race, or ethnicity\n* Patients must be undergoing HCT (any donor or stem cell source including autologous or cord blood)\n* History of prior transplants are permitted\n* 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\n* History of SARS-CoV-2 infection or vaccination of the donor are permitted.\n* Post-enrollment vaccination is anticipated and permitted\n* Administration of intravenous immunoglobulin therapy (IVIG) before or during the study is permitted\n\nExclusion Criteria:\n\n* Signs or symptoms of uncontrolled, active infection\n* Positive PCR result for SARS-CoV-2 within four weeks of scheduled conditioning\n* Pregnant or breastfeeding (this population is generally not cleared for transplant)\n\n * 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\n* Previous anaphylaxis or severe hypersensitivity reaction, including angioedema, to a mAb\n* Previous reaction to a mAb that required medical attention\n* Participants of other clinical studies that preclude the use of other investigational compounds\n* 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'}, 'identificationModule': {'nctId': 'NCT05135650', 'briefTitle': 'Pharmacokinetics of Sotrovimab as Pre-exposure Prophylaxis for COVID-19 in Hematopoietic Stem Cell Transplant Recipients, COVIDMAB Study', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'Pharmacokinetics of a SARS-CoV-2 Monoclonal Antibody in Hematopoietic Stem Cell Transplant Recipients (COVIDMAB)', 'orgStudyIdInfo': {'id': 'RG1121602'}, 'secondaryIdInfos': [{'id': 'NCI-2021-05949', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '10691', 'type': 'OTHER', 'domain': 'Fred Hutch/University of Washington Cancer Consortium'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prevention (Sotrovimab)', '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.', 'interventionNames': ['Other: Questionnaire Administration', 'Biological: Sotrovimab', 'Procedure: Biospecimen Collection']}], 'interventions': [{'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Prevention (Sotrovimab)']}, {'name': 'Sotrovimab', 'type': 'BIOLOGICAL', 'otherNames': ['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'], 'description': 'Given IV', 'armGroupLabels': ['Prevention (Sotrovimab)']}, {'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection'], 'description': 'Undergo blood and nasal swab sample collection', 'armGroupLabels': ['Prevention (Sotrovimab)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutch/University of Washington Cancer Consortium', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Alpana Waghmare', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutch/University of Washington Cancer Consortium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Marrow Donor Program', 'class': 'OTHER'}, {'name': 'Vir Biotechnology, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Alpana Waghmare', 'investigatorAffiliation': 'Fred Hutchinson Cancer Center'}}}}