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

NCT05210101 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 21-755
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

SARS CoV 2 Infection

Keywords

Prophylaxis; Immunocompromised host; Transplant; Monoclonal antibodies

Outcome Measures

Primary Outcomes (2)

• 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

  36 weeks after the second dose of sotrovimab

• 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.

  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)

• COVID-19-related Outcomes

  36 weeks after the second dose of sotrovimab

• General Health Quality of Life Measurement

  At treatment day 1, at treatment day 2

• 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)

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

Other Outcomes (3)

• Number of Participants With New Cellular or Antibody-mediated Rejection Events

  36 weeks after the second dose of sotrovimab

• New-onset or Worsening Graft-versus-host Disease in Hematopoietic Cell Transplant Recipients

  36 weeks after the second dose of sotrovimab

• New-onset Allograft or Stem Cell Failure Requiring Retransplantation in HCT Recipients

  36 weeks after the second dose of sotrovimab

Study Arms (1)

Sotrovimab

OTHER

Two 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.

Drug: Sotrovimab

Interventions

Sotrovimab DRUG

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.

Also known as: VIR-7831

Sotrovimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sophia Koo, M.D.: lead
• Massachusetts General Hospital: collaborator
• Dana-Farber Cancer Institute: collaborator
• GlaxoSmithKline: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• 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.

  PMID: 37328890 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

sotrovimab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Sophia Koo, MD
• Organization: Brigham and Women's Hospital

skoo@bwh.harvard.edu

6175258418

Study Officials

• Sophia Koo, MD

  Dana-Farber/Brigham and Women's Cancer Center

  PRINCIPAL INVESTIGATOR

• Jennifer Manne-Goehler, MD, ScD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Sarah P Hammond, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: January 27, 2022
• Study Start: February 7, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: August 15, 2024
• Results First Posted: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)