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
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|Condition or disease||Intervention/treatment||Phase|
|COVID-19 Infection Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm||Other: Questionnaire Administration Biological: Sotrovimab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
- Half-life of VIR-7831 in autologous vs allogeneic HCT [ Time Frame: Up to 24 weeks ]Comparisons will be tested using a t-test.
- 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.
- 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.
- 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.
- 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.
- 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
- Incidence of adverse events [ Time Frame: Up to 40 weeks ]Will monitor safety with routine labs as part of standard post-transplant care.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
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
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Alpana Waghmare||Fred Hutch/University of Washington Cancer Consortium|
|Responsible Party:||Fred Hutchinson Cancer Center|
|Other Study ID Numbers:||
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|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases
Antineoplastic Agents, Immunological
Physiological Effects of Drugs