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

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What is this study about?

This clinical trial is focused on studying the immune response in patients who have recovered from COVID-19 after receiving treatment with monoclonal antibodies. The study involves several treatments, including Spikevax (also known as mRNA-1273), Nuvaxovid (NVX-CoV2373), EVUSHELD, and Xevudy (Sotrovimab). These treatments are designed to help the body fight the virus by using different methods, such as mRNA technology or recombinant proteins. The purpose of the study is to evaluate how the immune system responds over time and how revaccination affects this response.

Participants in the study will have their immune responses monitored at various intervals after receiving monoclonal antibodies. This includes measuring the levels of antibodies and other markers of immune response at different times, such as 0, 1, 4, 6, 9, and 12 months after treatment. The study will also look at the effects of revaccination at different times, specifically at 4 months versus 12 months, to see how it impacts the immune response. The goal is to understand the best timing for revaccination to maintain a strong immune defense against COVID-19.

The study will provide valuable insights into how the immune system reacts to different treatments and vaccination schedules in people who have recovered from COVID-19. This information could help guide future vaccination strategies and improve protection against the virus. Participants will receive either the treatments mentioned or a placebo, and their immune responses will be carefully monitored throughout the study period.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a laboratory-confirmed SARS-CoV-2 infection and evaluating the severity of COVID-19 symptoms.

Eligibility criteria include being 12 years or older, having mild or moderate COVID-19, and being at high risk for severe infection due to factors like high body mass index, chronic diseases, or age over 65.

2 monoclonal antibody treatment

Eligible participants receive monoclonal antibodies (MAbs) treatment. This involves the administration of specific antibodies designed to help the immune system fight the virus.

The treatment is administered intravenously, which means it is given directly into a vein.

3 revaccination

Participants are scheduled for revaccination at different intervals to assess the impact on immune response. The revaccination occurs either 4 months or 12 months after the initial MAbs treatment.

The vaccines used include Spikevax, Nuvaxovid, EVUSHELD, Xevudy, and Comirnaty, administered intramuscularly, which means injected into a muscle.

4 follow-up assessments

Regular follow-up assessments are conducted to evaluate the immune response over time. These assessments occur at 0, 1, 4, 6, 9, and 12 months after the MAbs infusion.

The assessments include measuring antibody levels and cellular immunity using specific tests to understand how the body responds to the virus and the vaccines.

5 study completion

The study is expected to conclude by September 2024. At this point, all data collected will be analyzed to understand the effectiveness of the treatments and revaccination schedules.

Who Can Join the Study?

  • Patients must be diagnosed with COVID-19.
  • Patients must be 12 years old or older.
  • Patients must have a laboratory-confirmed SARS-CoV-2 infection.
  • Patients must have mild or moderate COVID-19 symptoms that started within 7 days of evaluation.
  • Patients must be at high risk for severe COVID-19 infection. High-risk factors include:
    • Body mass index (BMI) of 30 or higher, or above the 95th percentile for age and gender.
    • Chronic renal failure, which means long-term kidney problems.
    • Uncontrolled diabetes mellitus, with a blood sugar level (HbA1c) higher than 9.0%.
    • Primary or secondary immunodeficiency, meaning a weakened immune system.
    • Age over 65 years.
    • Cardio-cerebrovascular disease, which includes heart and blood vessel problems.
    • Chronic obstructive pulmonary disease (COPD) or other long-term lung diseases.
    • Chronic liver disease, meaning long-term liver problems.
    • Hemoglobinopathies, which are blood disorders affecting hemoglobin.
    • Neurodevelopmental and neurodegenerative pathologies, which are brain and nerve disorders.
  • Treatment is possible beyond 7 days from symptom onset only for patients with immunodeficiency who have:
    • Negative SARS-CoV-2 serology, meaning no antibodies detected in the blood.
    • Prolonged positivity to a molecular swab, meaning the virus is still detected in tests.

Who Cannot Join the Study?

  • Individuals who have not had a Covid-19 infection cannot participate. This means if you have never been infected with the virus that causes Covid-19, you are not eligible.
  • Participants who have not received monoclonal antibodies (MAbs) after a Covid-19 infection are excluded. Monoclonal antibodies are special proteins made in a lab that can help your body fight the virus.
  • People who are not within the specified age ranges are excluded. The study is only for certain age groups, so if you are too young or too old, you cannot join.
  • Individuals who are not part of the specified clinical trial groups are excluded. This means the study is looking for people with specific characteristics or conditions.
  • Participants who are not willing to follow the study’s revaccination schedule are excluded. This means if you do not agree to get vaccinated again at certain times, you cannot participate.
  • People who are not part of the vulnerable population are excluded. Vulnerable populations may include groups like pregnant women, children, or the elderly, depending on the study’s focus.

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 Status
National Institute For Infectious Diseases Lazzaro Spallanzani Rome Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not yet recruiting
13.09.2022

Trial locations

Investigated drugs:

Monoclonal Antibodies (MAbs) are used in this trial to treat patients who have recovered from COVID-19. These are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses. In this study, they are used to help understand how the immune system responds over time after treatment and how it might affect future vaccinations.

COVID-19 Infection – COVID-19 is a respiratory illness 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 distress requiring hospitalization. Some individuals may experience loss of taste or smell, muscle aches, and gastrointestinal symptoms. The progression of the disease varies, with some recovering quickly while others may develop complications such as pneumonia. Long-term effects, known as “long COVID,” can persist even after the acute phase of the illness has resolved.

Trial ID:
2024-514071-17-00
Protocol code:
Renoir
Trial Phase:
Therapeutic confirmatory (Phase III)

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