COVID-19 InfectionPhase 1NCT05135650
Pharmacokinetics of Sotrovimab as Pre-exposure Prophylaxis for COVID-19 in Hematopoietic Stem Cell Transplant Recipients, COVIDMAB Study
A Phase 1 study testing Questionnaire Administration, Sotrovimab and Biospecimen Collection in people with COVID-19 Infection and Hematopoietic and Lymphoid Cell Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Infection, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Questionnaire Administration, Sotrovimab and Biospecimen Collection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2022to 10 Jan 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Pharmacokinetics of a SARS-CoV-2 Monoclonal Antibody in Hematopoietic Stem Cell Transplant Recipients (COVIDMAB)
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.
Read the 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.
- Being tested
- Questionnaire Administration, Sotrovimab, Biospecimen Collection
- Medical subject headings
- COVID-19, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire AdministrationOther
Ancillary studies
SotrovimabBiological
Also called Anti-SARS-CoV-2 Spike Protein Monoclonal Antibody VIR-7831, GSK 4182136, GSK-4182136, GSK4182136
Given IV
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood and nasal swab sample collection
| Study group | Role | What they receive |
|---|---|---|
| Prevention (Sotrovimab) | Experimental | 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. Receives: Other: Questionnaire Administration; Biological: Sotrovimab; Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 24 weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 4 and 24 weeks
Number of Participants With Adverse Events
Will monitor safety with routine labs as part of standard post-transplant care.
Measured: Up to 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start25 Jan 2022
- Primary completion18 Oct 2022
- Study completion10 Jan 2023
Why it stopped: Terminated due to FDA withdrawal of the emergency use authorization (EUA) for sotrovimab
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Marrow Donor Program, Vir Biotechnology, Inc.
- Responsible party
- Principal investigator, Alpana Waghmare, Fred Hutchinson Cancer Center
- Investigators
- Alpana Waghmare, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135650
- Sponsor's protocol ID
- RG1121602
- Other IDs
- NCI-2021-05949, 10691
- Status last verified
- Feb 2025
- First submitted
- 23 Nov 2021
- Last updated
- 13 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of a SARS-CoV-2 Monoclonal Antibody in Hematopoietic Stem Cell Transplant Recipients (COVIDMAB)
- ClinicalTrials.gov ID
- NCT05135650
- Acronym / sponsor ID
- RG1121602
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to FDA withdrawal of the emergency use authorization (EUA) for sotrovimab
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Marrow Donor Program, Vir Biotechnology, Inc.
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 18 Oct 2022 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 26 Nov 2021 (actual)
- Results
- Posted 13 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (Sotrovimab) | Experimental | Other: Questionnaire Administration, Biological: Sotrovimab, Procedure: Biospecimen CollectionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
- Previous anaphylaxis or severe hypersensitivity reaction, including angioedema, to a mAb
- Previous reaction to a mAb that required medical attention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire AdministrationAncillary studies | Other | Prevention (Sotrovimab) |
| SotrovimabAlso: Anti-SARS-CoV-2 Spike Protein Monoclonal Antibody VIR-7831, GSK 4182136, GSK-4182136, GSK4182136Given IV | Biological | Prevention (Sotrovimab) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood and nasal swab sample collection | Procedure or surgery | Prevention (Sotrovimab) |
Primary outcome
Half-life of Sotrovimab (VIR-7831) Post-transplant
Time frame: Up to 24 weeks
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.
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. Data analysis was not performed.
8 secondary outcomes
Half-life of VIR-7831 in Matched vs Mismatched Donors
Time frame: Up to 24 weeks
Half-life of VIR-7831 in Autologous vs Allogeneic HCT
Time frame: Up to 24 weeks
VIR-7831 Exposure in Patients With Diarrhea vs no Diarrhea
Time frame: Up to 24 weeks
VIR-7831 Exposure in Patients With and Without Graft Versus Host Disease
Time frame: Up to 24 weeks
Number of Participants With Breakthrough SARS-CoV-2 Acquisition
Time frame: Up to 24 weeks
Antibody Clearance Rate From Serum/Plasma
Time frame: Up to 24 weeks
Number of Participants With Presence of Anti-drug Antibodies From Serum/Plasma
Time frame: At 4 and 24 weeks
Number of Participants With Adverse Events
Time frame: Up to 40 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alpana Waghmare principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Questionnaire Administration, Sotrovimab and Biospecimen Collection in people with COVID-19 Infection and Hematopoietic and Lymphoid Cell Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Half-life of Sotrovimab (VIR-7831) Post-transplant (time frame: Up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.