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SARS CoV 2 InfectionPhase 2NCT05210101

A Safety and Tolerability Study of Sotrovimab (VIR-7831) Prophylaxis Against COVID-19 in Immunocompromised Individuals

A Phase 2 study testing Sotrovimab in people with SARS CoV 2 Infection, run by Sophia Koo, M.D. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label study examining the safety and tolerability of sotrovimab, administered in two sequential doses as prophylaxis in immunocompromised patients with impaired humoral immunity against SARS-CoV-2. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
SARS CoV 2 Infection
What is being tested?
Sotrovimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
3 sitesUnited States
Study dates
7 Feb 2022to 28 Feb 2023
Phase
Phase 2
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

  • Participant must be 18 years of age or older at the time of consent and weigh at least 40 kg. Children will be excluded from this study because dosing and adverse event data are limited for the use of sotrovimab in participants <18 years of age.
  • Participant must have one of the following immunocompromising conditions that increases their likelihood of having an impaired humoral immune response to SARS-CoV-2, while also increasing their risk of being infected with SARS-CoV-2 and risk of progression to severe COVID-19:
  • Exposure to an anti-CD20 monoclonal antibody (e.g. all formulations of rituximab, obinutuzumab, ofatumumab, ocrelizumab, ibritumomab, tositumomab) for a hematologic malignancy or an autoimmune/inflammatory disease in the 12-month period prior to consent.
  • Allogeneic hematopoietic cell transplant ≥ 3 months and ≤ 1 year prior to consent; or allogeneic hematopoietic cell transplant >1 year prior to consent plus active graft-versus host disease on systemic immunosuppressive therapy.
  • Chimeric antigen receptor (CAR)-T cell therapy ≥ 4 weeks and ≤ 2 years prior to consent.
  • Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), multiple myeloma, or Waldenström macroglobulinemia.
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  • Solid organ transplant recipient receiving immunosuppressive therapy.
  • Congenital immunodeficiency syndrome (e.g. Wiskott-Aldrich syndrome, DiGeorge syndrome, common variable immunodeficiency).
  • Patients with hematologic malignancy or autoimmune/inflammatory disease exposed to immunosuppressive medications specifically associated with a blunted humoral immune response to SARS-CoV-2 vaccination (e.g. mycophenolate mofetil, azathioprine, methotrexate, Bruton tyrosine kinase inhibitors, ruxolitinib, venetoclax, or corticosteroids (prednisone >20mg or equivalent daily for at least 14 days) in the 3-month period prior to consent.
  • Female participants must be:
  • Postmenopausal for at least 1 year;
  • Post-hysterectomy and/or post-bilateral oophorectomy;
  • Of childbearing potential, with a negative urine or serum human chorionic gonadotropin pregnancy test prior to each sotrovimab dose, and agree to use a highly effective method of birth control throughout the study period.
  • Participants must have a negative or low-positive (<50 U/mL) SARS-CoV-2 spike antibody assay result within 28 days of consent.

Who cannot join

  • Participants with an active SARS-CoV-2 infection, with a positive SARS-CoV-2 RT-PCR or antigen test result within 21 days prior to consent.
  • Participants with symptoms suggestive of SARS-CoV-2 infection.
  • Close contact (less than 6 feet away for a cumulative total of ≥ 15 minutes over a 24-hour period) with an individual with COVID-19 in the 14 days prior to consent.
  • Individuals who are pregnant or breastfeeding.
  • Participants who are receiving any other investigational agents.
  • Participants who, in the judgment of the investigator, are likely to have a life expectancy of less than one year.
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  • Known hypersensitivity to any constituent present in sotrovimab or any other anti-SARSCoV-2 monoclonal antibody product.
  • Active enrollment on another interventional research study of any agent for the treatment or prophylaxis of SARS-CoV-2 infection.
  • Exposure to any other anti-SARS-CoV-2 monoclonal antibody product for the treatment of COVID-19 in the prior 6 months.
  • Exposure to any other anti-SARS-CoV-2 monoclonal antibody product for prophylaxis against COVID-19 infection in the prior 12 months.
  • Receipt of a SARS-CoV-2 vaccine dose within the prior 28 days.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: A Safety and Tolerability Study of Sotrovimab (VIR-7831) Prophylaxis Against COVID-19 Infection in Immunocompromised Individuals With Impaired SARS-CoV-2 Humoral Immunity

This is an open-label study examining the safety and tolerability of sotrovimab, administered in two sequential doses as prophylaxis in immunocompromised patients with impaired humoral immunity against SARS-CoV-2.

Read the detailed description

This open-label study evaluated the safety and tolerability of sotrovimab, administered in two sequential doses, as COVID-19 prophylaxis in immunocompromised patients with impaired humoral immunity against SARS-CoV-2. 93 patients were enrolled in this study, 10 patients in an initial lead-in PK cohort initially planned to determine the optimal dosing interval between the first and second dose of sotrovimab and assess the safety and tolerability of the drug (prior to the spread of the BA.2 variant, which made it necessary to administer the repeat sotrovimab dose earlier than originally anticipated, using theoretical modeling and logistical considerations), 50 patients (including the 10 patients in the lead-in PK cohort) in a safety and tolerability lead-in cohort to examine rates of infusion-related reactions (IRR) with a 30-minute sotrovimab IV infusion, and the remainder in an expansion cohort for further assessment of the safety and tolerability of sotrovimab in this patient population, with the sotrovimab infusion duration determined by the rate of IRRs in the 50-patient safety and tolerability lead-in cohort. The first treatment consisted of sotrovimab 500mg as an intravenous (IV) infusion over 30 minutes, followed by a one-hour monitoring period. The second treatment, administered in a time when BA.2 became the dominant SARS-CoV-2 variant, consisted of sotrovimab 2000mg as an intravenous (IV) infusion over 60 minutes, followed by a two-hour monitoring period in the first 10 patients administered this dose, who comprised a second lead-in safety cohort for this 2000mg dose, and a one-hour monitoring period in all patients subsequently receiving their second sotrovimab dose, maintaining this one-hour monitoring period as long as there were no grade >2 infusion-related reactions or other SAEs potentially related to the sotrovimab dose in this 2000mg dose lead-in safety cohort.

Being tested
Sotrovimab
Keywords
Prophylaxis, Immunocompromised host, Transplant, Monoclonal antibodies
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SotrovimabDrug

    Also called VIR-7831

    Two intravenous (IV) doses of sotrovimab were administered over the study period, the first 500mg, and the second 2000mg, in light of the reduced antiviral neutralization of sotrovimab against the BA.2 subvariant.

Study groups in NCT05210101
Study groupRoleWhat they receive
SotrovimabOtherTwo intravenous (IV) doses of sotrovimab were be administered in total - the first on Treatment Day 1 (500mg) and the second on Treatment Day 2, approximately 8-14 weeks after the first dose, at a higher 2000mg dose, in light of the reduced antiviral susceptibility of the BA.2 subvariant to sotrovimab, with the dosing interval determined by theoretical modeling of the duration of efficacy of sotrovimab as antiviral prophylaxis based on the rising prevalence of the Omicron BA.2 subvariant.
Receives: Drug: Sotrovimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Patients With Treatment-emergent Adverse Events, Serious Adverse Events, and Adverse Events of Specific Interest

    Proportion of patients with treatment-emergent adverse events, serious adverse events, and adverse events of specific interest (including infusion-related and hypersensitivity reactions, anti-drug antibody (ADA) levels, and antibody-dependent enhancement

    Measured: 36 weeks after the second dose of sotrovimab

  2. Half-life of Sotrovimab in Immunocompromised Patients With Impaired Humoral Immunity Against SARS-CoV-2.

    Evaluation of half-life of sotrovimab in immunocompromised patients with impaired humoral immunity against SARS-CoV-2.

    Measured: Within 1 hour of the first dose infusion of sotrovimab and on day 11, 29, and 59. Prior to the second dose, within 1 hour of the second dose infusion of sotrovimab, and 11, 29, 59, and 168 days after

Secondary outcomes (3)

  1. COVID-19-related Outcomes

    The proportion of study subjects who: (a) develop COVID-19 (of any severity), (b) severe COVID-19, (c) Emergency department (ED) visits, inpatient hospitalization, or ICU hospitalizations within 28 days of a new diagnosis of SARS-CoV-2, (d) need for new or increasing supplemental oxygen or mechanical ventilation within 28 days of a new diagnosis of SARS-CoV-2, and (e) death due to any cause during the study follow-up period.

    Measured: 36 weeks after the second dose of sotrovimab

  2. General Health Quality of Life Measurement

    Health-related quality of life was assessed using the 36-Item Short Form Survey (SF-36), specifically focusing on the General Health domain. Each question in this domain was scored as follows:

    For questions 33 and 35, responses were scaled: 1 = 0, 2 = 25, 3 = 50, 4 = 75, and 5 = 100.

    For questions 1, 34, and 36, responses were scaled: 1 = 100, 2 = 75, 3 = 50, 4 = 25, and 5 = 0.

    The scores for these five questions were summed to create a composite General Health score, with possible total scores ranging from 0 (indicating the best perceived general health) to 500 (indicating the worst perceived general health). Lower scores indicate better perceived general health.

    We calculated the mean General Health score at two time points: treatment day 1 and treatment day 2. The reported results reflect the difference between these mean scores, with negative differences indicating improvement and positive differences indicating a decline in p

    Measured: At treatment day 1, at treatment day 2

  3. In Patients Who Develop COVID-19, the Greatest Extent of COVID-19 Symptoms, as Assessed Using the 8-point National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS)

    National Institute of Allergy and Infectious Disease Ordinal Scale (NIAD-OS) was assessed at the end of hospitalization or 14 days after the diagnosis of COVID-19. The worst reported scale value was used in the analysis to adequately represent the greatest extent of their COVID-19 infection.

    NIAID-OS Scale Value Description

    1. Not hospitalized, no limitations on activities
    2. Not hospitalized, limitation on activities or/or requiring home oxygen
    3. Hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care
    4. Hospitalized, not requiring supplemental oxygen
    5. Hospitalized, requiring supplemental oxygen
    6. Hospitalized, on non-invasive ventilation or high flow oxygen devices
    7. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
    8. Death

    Measured: from covid day 1 to end of hospitalization or covid day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2022
  2. Study start7 Feb 2022
  3. Primary completion28 Feb 2023
  4. Study completion28 Feb 2023

Resources

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 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05210101
Sponsor's protocol ID
21-755
Status last verified
Aug 2024
First submitted
25 Jan 2022
Last updated
15 Aug 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gonzalez-Bocco IH, Beluch K, Cho A, Lahoud C, Reyes FA, Moshovitis DG, Unger-Mochrie GM, Wang W, Hammond SP, Manne-Goehler J, Koo S. Safety and tolerability study of sotrovimab (VIR-7831) prophylaxis against COVID-19 infection in immunocompromised individuals with impaired SARS-CoV-2 humoral immunity. Pilot Feasibility Stud. 2023 Jun 16;9(1):100. doi: 10.1186/s40814-023-01325-y.

    PubMed 37328890

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sotrovimab in people with SARS CoV 2 Infection, run by Sophia Koo, M.D. at 3 sites 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 14 inclusion and 11 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: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 15 Aug 2024). 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?

Proportion of Patients With Treatment-emergent Adverse Events, Serious Adverse Events, and Adverse Events of Specific Interest (time frame: 36 weeks after the second dose of sotrovimab). 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?

On the ClinicalTrials.gov record for NCT05210101, which also lists 1 linked publication.

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 15 Aug 2024.

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