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Sotrovimab

Clinical trials investigating Sotrovimab are studying how it is used in people with SARS-CoV-2 infection and COVID-19. These trials focus on outcomes such as viral load, immune response, and possible virus changes during treatment. The target groups include patients treated after infection and people being followed after recovery.

Table of contents

Trial overview

These clinical trials are studying Sotrovimab as part of research on COVID-19 and SARS-CoV-2 infection.[1][2] The available trial data show two Phase 3 interventional studies that focus on virus control, immune response, and follow-up after treatment with monoclonal antibodies.[1][2]

TURN-COVID Biobank study

The first study is the TURN-COVID Biobank, a Dutch cohort study for the evaluation of neutralizing monoclonal antibodies and other antiviral agents against SARS-CoV-2.[1] It is listed as a Phase 3 interventional study with 400 participants and the status Completed.[1]

This study includes people with SARS-CoV-2 infection and examines several treatment options used in the study setting, including Xevudy, which is the product name listed for Sotrovimab in the trial data.[1] Other listed treatments in the same study are Ronapreve, EVUSHELD, and Paxlovid.[1]

The main goals are to study how the viral load changes during and after treatment, whether infection occurs when these treatments are used to prevent disease, and whether viral variants, spike mutations, or immune escape appear during treatment.[1] The study also measures viral antibody and inflammatory response changes over time and aims to create a biobank for future research.[1]

Immune response and revaccination study

The second study is titled Temporal kinetics of antibody and cellular response markers and relative impact of revaccination in patients recovered from COVID-19 after treatment with monoclonal antibodies.[2] It is an authorised Phase 3 interventional study with 150 participants.[2]

This study includes people who recovered from COVID-19 after receiving monoclonal antibodies and looks at the effect of different vaccination histories at the time of infection.[2] The intervention list includes Comirnaty, Spikevax, EVUSHELD, Xevudy, and Nuvaxovid.[2]

The main endpoint is the effect of revaccination at 4 versus 12 months on the timing of humoral and cellular response markers.[2] In simple terms, the study is checking how antibody-based and cell-based immune responses change over time and whether the timing of revaccination matters.[2]

Outcomes and endpoints

The first trial measures SARS-CoV-2 viral load kinetics, infection occurrence when used as prophylaxis, viral variant changes, spike mutations, immune escape, and immune and inflammatory response kinetics.[1] It also has a biobank goal, which means it collects and stores samples for future questions about current and future COVID-19 treatments.[1]

The second trial measures the effectiveness of revaccination timing on the temporal kinetics of humoral and cellular response markers.[2] This means the researchers are tracking how the immune response changes across time after vaccination and after earlier monoclonal antibody treatment.[2]

Who is being studied

The target population in these trials includes people with SARS-CoV-2 infection or COVID-19 infection, as well as people who recovered after receiving monoclonal antibodies.[1][2] Some participants are studied based on their vaccination status at the time of infection or during follow-up.[2]

  • People with active infection: These participants help researchers see how the treatment affects virus levels and immune responses during illness.[1]
  • People recovered after treatment: These participants help researchers understand longer-term immune markers after monoclonal antibody treatment.[2]
  • People with different vaccination timing: These participants help researchers compare revaccination at 4 months and 12 months.[2]

Study design and phase

Both studies are interventional, which means researchers are actively giving treatments or vaccines and then measuring the results.[1][2] Both are also Phase 3 studies, which usually means they are testing the treatment in larger groups and looking closely at real patient outcomes.[1][2]

The trial data do not provide detailed participant rules such as age limits or exclusion criteria, so the most reliable description is that the studies focus on patients with SARS-CoV-2 infection, COVID-19 infection, or recovery after monoclonal antibody treatment.[1][2]

Trial ID Phase Condition studied Status Enrollment
NCT05195060 Phase 3 SARS-CoV-2 infection Completed 400
2024-514071-17-00 Phase 3 Covid-19 infection Authorised 150

FAQ

  • What are the clinical trials with Sotrovimab studying? The trials are looking at viral load changes, immune response over time, and whether virus variants or spike mutations appear during treatment. One study also examines how revaccination affects immune markers after monoclonal antibody treatment.
  • Who can take part in these trials? The studies include people with SARS-CoV-2 infection or COVID-19 infection, including patients who received monoclonal antibodies and later recovered. Some participants are also being followed based on their vaccination status.
  • What phase are the Sotrovimab trials? The trials listed are Phase 3 studies. Phase 3 means the treatment is being studied in larger groups to better understand its effects in real patient settings.
  • What conditions are being studied? The main conditions are SARS-CoV-2 infection and COVID-19 infection. The studies also look at recovery after infection and the effects of revaccination in people who previously received monoclonal antibodies.
  • What outcomes are measured in these trials? The trials measure viral load kinetics, which means how the amount of virus changes over time, and humoral and cellular immune responses, which are antibody and cell-based immune markers. They also look at infection occurrence, viral variants, and immune escape.

Ongoing Clinical Trials on Sotrovimab

  • Study on Immune Response in COVID-19 Recovered Patients Treated with Monoclonal Antibodies: Effects of Revaccination with Elasomeran, Tozinameran, and Cilgavimab

    Not yet recruiting

    1 1 1 1
    Investigated drugs:
    Italy

  • Study on the Use of Casirivimab, Cilgavimab, Sotrovimab, and Nirmatrelvir for Patients with COVID-19 Infection

    Not recruiting

    1 1 1 1
    Investigated drugs:
    The Netherlands

Glossary

  • SARS-CoV-2: The virus that causes COVID-19.
  • COVID-19: The illness caused by SARS-CoV-2 infection.
  • Phase 3: A later stage of clinical research in larger groups of people, used to study how well a treatment works and to collect more safety and effectiveness data.
  • Interventional study: A study where participants receive a treatment, vaccine, or other planned action so researchers can measure its effects.
  • Viral load: The amount of virus in a person’s body or sample. Researchers track how this changes over time.
  • Kinetics: How something changes over time, such as virus levels or immune markers.
  • Humoral response: The part of the immune response that uses antibodies in the blood.
  • Cellular response: The part of the immune response that involves immune cells working against infection.
  • Biobank: A stored collection of biological samples and related information that can be used for future research.
  • Immune escape: When a virus changes in a way that helps it avoid the immune response.

References