2024-514071-17-00
尚未招募
4 期
Temporal kinetics of antibody and cellular response markers and relative impact of revaccination in patients recovered from COVID-19 after treatment with monoclonal antibodies
National Institute For Infectious Diseases Lazzaro Spallanzani1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年7月31日最近更新:
概览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- National Institute For Infectious Diseases Lazzaro Spallanzani
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Evaluation of the effectiveness of revaccination at 4 versus 12 months on the temporal kinetics of humoral and cellular response markers.
概览
简要总结
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
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
Evaluation of the effectiveness of revaccination at 4 versus 12 months on the temporal kinetics of humoral and cellular response markers.
Evaluation of the effectiveness of revaccination at 4 versus 12 months on the temporal kinetics of humoral and cellular response markers.
次要结局
- 1) Evaluate the anti-N IgG antibody titer at 0, 1, 4, 6, 9, 12 months after the MAbs infusion 2) Evaluate the anti-S IgG antibody titer at 0, 1, 4, 6, 9, 12 months after the MAbs infusion 3) Evaluate the titer of neutralizing antibodies at 0, 1, 4, 6, 9, 12 months after the MAbs infusion 4) Evaluate cellular immunity to S and N with IGRA test at 0, 4, 12 months after MAbs infusion
研究者
Valentina Mazzotta
Scientific
National Institute For Infectious Diseases Lazzaro Spallanzani
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
Temporal kinetics of antibody and cellular response markers and relative impact ofrevaccination in patients recovered from COVID-19 after treatment with monoclonalantibodiesCovid-19 infectionMedDRA version: 20.0Level: HLGTClassification code: 10047438Term: Viral infectious disorders Class: 10021881Therapeutic area: Diseases [C] - Virus Diseases [C02]CTIS2024-514071-17-00ational Institute For Infectious Diseases Lazzaro Spallanzani83
招募中
不适用
Analysis of time-dependent changes in immune cell distribution and expression of immunological cytokines in patients with different stages of peripheral arterial disease (PAD)I70.2Atherosclerosis of arteries of extremitiesDRKS00032916niversitätsklinikum Augsburg100
已完成
不适用
Assessment of time course of changes in antibody titers after vaccination with a Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Salk vaccine): DTap-wIPV to consider necessity of booster vaccinations.Healthy childrenJPRN-UMIN000016570The Japanese Society for Vaccinology50
已完成
不适用
Kinetics of immune responses and characteristics of antigen-specific B cells after Bordetella pertussis vaccinatioPertussisWhooping cough10004018NL-OMON52999eids Universitair Medisch Centrum20
尚未招募
不适用
Immunomonitoring in neuroblastoma patientseuroblastoom, immuuntherapie, farmacokinetiek van dinutuximabNeuroblastoma, immunotherapy, pharmacokinetics of dinutuximabNL-OMON24604Prinses Máxima Centrum60