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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Lzeki Uswnchtqmkag Mboezrs Crbbmdx (lvluk	Leiden	The Netherlands
Apvbjriyg Udt	Amsterdam	The Netherlands
Uourspipwdnb Mfnfees Cyajkqw Gcpsbyznk	Groningen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	14.12.2021

Trial locations

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.

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.

Trial ID:

2024-515263-60-00

Protocol code:

NL78705.018.21

NCT ID:

NCT05195060

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?