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 trial about?
A plain-language summary of the goals, design and what participants do
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.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
18 criteria
- 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 trial?
6 criteria
- 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.
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