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Temporal kinetics of antibody and cellular response markers and relative impact of revaccination in patients recovered from COVID-19 after treatment with monoclonal antibodies
EU CTIS ID: 2024-514071-17-00
What this study is testing
Evaluate the extent and persistence over time of the humoral and cellular immune response in subjects who received MAbs after SARS-CoV-2 infection and had a different vaccination status at the time of infection and evaluate the impact of different revaccination times on the humoral and cellular response
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The subjects eligible for inclusion in the study are patients diagnosed with COVID-19 who meet the access criteria established by the Ministry / AIFA / Regions Program, with the following access criteria [10] (In case of changes, the criteria inclusion will be modified accordingly): a. 18 year old patients and older with laboratory confirmed SARS-CoV-2 infection and mild or moderate COVID-19 disease onset within 7 days of evaluation who are at high risk for severe COVID-19 infection. Possible risk factors include the following: • body mass index (BMI) =30, or> 95th percentile for age and gender • chronic renal failure • uncontrolled diabetes mellitus (HbA1c> 9.0% 75 mmol / mol) or with chronic complications • primary or secondary immunodeficiency • age> 65 years • cardio-cerebrovascular disease • chronic obstructive pulmonary disease and / or other chronic respiratory disease • chronic liver disease • hemoglobinopathies • neurodevelopmental pathologies and neurodegenerative pathologies. b. Treatment is possible beyond 7 days from onset only in subjects with immunodeficiency who have: negative SARS-COV-2 serology and prolonged positivity to molecular swab
You likely can't join if
- - Patients under 18 year old - Inability to sign informed consent - hospitalized for COVID-19 - Have any concomitant serious systemic disease, condition or disorder which, in the opinion of the investigator, should preclude participation in this study - known allergy or hypersensitivity to the components of the study drug - Unmanageable drug interactions to treatment drugs (Annex 4).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.