Not recruiting

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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of COVID-19, which is caused by the SARS-CoV-2 virus. The study involves the use of several treatments, including Ronapreve, Evusheld, Xevudy, and Paxlovid. Ronapreve contains the active substance casirivimab, Evusheld contains cilgavimab, Xevudy contains sotrovimab, and Paxlovid contains nirmatrelvir. These treatments are designed to help the body fight the virus by using special proteins called monoclonal antibodies or antiviral agents.

The purpose of this study is to understand how these treatments affect the virus in the body, including how the virus changes and how the body responds to the treatment. The study will also look at how these treatments can prevent COVID-19. Participants will receive one of the treatments or a placebo, and their health will be monitored to see how the virus behaves during and after treatment. This includes checking for any changes in the virus, such as mutations, and observing the body's immune response.

The study will create a biobank, which is a collection of biological samples, to help answer future questions about the use of these treatments compared to new COVID-19 treatments that are being developed. The study will take place over a period of time, and participants will be closely monitored to gather important information about the effectiveness and safety of these treatments.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participation is confirmed for individuals aged 18 years or older who are receiving treatment with neutralizing antibodies or other antiviral medications for SARS-CoV-2 infection or as a preventive measure.
Step 2
Initial treatment phase
The initial treatment involves the administration of medications designed to combat the SARS-CoV-2 virus. These include Ronapreve (casirivimab and cilgavimab) and EVUSHELD (sotrovimab), both given as a solution for injection or infusion through a vein.
Additionally, Xevudy is provided as a concentrate for infusion, also administered intravenously.
Step 3
Oral medication phase
During this phase, Paxlovid (nirmatrelvir) is taken orally in the form of film-coated tablets. The dosage and frequency are determined by the healthcare provider based on individual needs.
Step 4
Monitoring and follow-up
Throughout the study, regular monitoring of viral load and immune response is conducted to assess the effectiveness of the treatment. This includes observing any changes in the virus, such as mutations or resistance.
The study aims to understand how the body responds to the treatment over time, including any changes in antibody levels and inflammation.
Step 5
Biobank contribution
Participants contribute to a biobank, which is a collection of biological samples used for future research. This helps in understanding the current use of treatments and comparing them with new therapies under development.
Step 6
Completion of the study
The study is expected to conclude by September 2025. Participants will be informed about the outcomes and any relevant findings related to the treatment of SARS-CoV-2.

Who can join the trial?

4 criteria

All patients must be treated with **neutralizing SARS-CoV-2 antibodies** and other **antivirals**. These are medicines used to fight the virus or prevent it as part of standard care.
Patients must be **18 years old or older**.
Both **men and women** can participate.
Participants should not be from a **vulnerable population**. This means people who might need special protection or care are not included.

Who cannot join the trial?

3 criteria

Individuals who are not infected with SARS-CoV-2, which is the virus that causes COVID-19.
Children under the age of 4 years.
Individuals who are part of a vulnerable population, meaning they may have special needs or circumstances that require extra protection.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Leids Universitair Medisch Centrum (LUMC)
Responsive
Leiden, The Netherlands
Stichting Radboud University Medical Center
Verified
Nijmegen, The Netherlands

Trial locations

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Investigated drugs

Neutralizing Monoclonal Antibodies
are a type of medication designed to help the immune system fight off the SARS-CoV-2 virus, which causes COVID-19. These antibodies are made in a lab and work by attaching to the virus, preventing it from entering and infecting healthy cells. They are used both to treat people who are already infected and to prevent infection in those who have been exposed to the virus.
Other Antiviral Agents
are medications that help reduce the ability of the SARS-CoV-2 virus to multiply and spread in the body. These agents can help lessen the severity of the illness and shorten the duration of symptoms. They are used to treat people who have COVID-19 and can also be used to prevent infection in people who have been exposed to the virus.

What is already known about the treatment

Neutralizing Monoclonal Antibodies – These are administered intravenously and are currently being studied for their effectiveness against SARS-CoV-2 infection. They are in clinical trials to evaluate their role in reducing viral load and preventing infection. The main therapeutic indication is the treatment and prevention of COVID-19. At the molecular level, they work by binding to the virus's spike protein, preventing it from entering human cells. They are classified as antiviral agents.

Investigated diseases

COVID-19 – COVID-19 is an infectious disease caused by the SARS-CoV-2 virus. It primarily spreads through respiratory droplets when an infected person coughs, sneezes, or talks. The disease can range from mild symptoms like fever, cough, and fatigue to severe respiratory issues requiring hospitalization. Some individuals may experience loss of taste or smell, muscle aches, and sore throat. The progression of the disease varies, with some recovering quickly while others may develop complications. Long-term effects, known as "long COVID," can occur in some individuals, leading to prolonged symptoms.