Clinical trial · Interventional
Pharmacokinetics of Sotrovimab as Pre-exposure Prophylaxis for COVID-19 in Hematopoietic Stem Cell Transplant Recipients, COVIDMAB Study
Pharmacokinetics of a SARS-CoV-2 Monoclonal Antibody in Hematopoietic Stem Cell Transplant Recipients (COVIDMAB)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated due to FDA withdrawal of the emergency use authorization (EUA) for sotrovimab
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| COVID-19 Infection | — | UNRESOLVED | — |
| Hematopoietic and Lymphoid Cell Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Sotrovimab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- 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
Primary outcomes (2)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available