Longitudinal Observation of Clinical and Immunological Profiles After SARS-Cov-2 Infection
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Analysis of demographic profile (Age) of recovered COVID-19 patients [at inclusion]
研究概览
简要总结
There are very few long-term studies that analyze the immune responses in patients recovered from COVID-19 caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
The main aim of this study is to analyze the clinical profile and immune responses of recovered COVID-19 patients in a representative cohort of people in the Umbria region of Italy. The participants had a history of testing positive for SARS-CoV-2 in March 2020 by Reverse Transcriptase- Quantitative Polymerase Chain Reaction (RT-qPCR). The participants were invited for voluntary participation in a seroprevalence study. This study analyzes longitudinally the presence of antibodies against SARS-CoV-2 by sequential serological tests at different time points using two FDA-approved Immunoassays. At the first serum sample collection, the participants were asked to provide information about their COVID-19 clinical history including clinical profile, co-morbidities, and treatment undertaken using a standardized questionnaire. Successive sequential serological assessments were conducted to understand the immune responses in these recovered patients.
Moreover, stage two of the study involves, analysis of antibody titers in recovered vaccinated individuals and their follow-up.
详细描述
Study design: A monocentric pilot longitudinal observational study
Study subjects: patients recovered from SARS-CoV-2 infection in March 2020 (detected by RT-PCR)
Study method: The study was conducted after written informed consent for voluntary participation. The antibody titers were longitudinally analyzed by sequential serological tests at different time points (TPs) using two FDA-approved Immunoassays. At the first serum sample collection, the participants were asked to provide information about their COVID-19 clinical history including clinical profile, co-morbidities, and the treatment undertaken using a standardized questionnaire.
From May 2020 to January 2021:
Anti-Nucleocapsid (NCP) antibodies were analyzed using FDA-approved CLIA immunoassay through sequential serum samples.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals who tested positive for SARS-CoV-2 in March
- •These patients will be divided into two groups and followed up over time. The first group will include patients who have recovered and have not received the vaccine. The second group will include patients who have recovered and have received the vaccine.
- •No acute respiratory infection or active SARS-CoV-2 infection.
- •Informed consent of the adult participant.
排除标准
- •Individuals <18 years or >80 years.
- •No informed consent by the adult participant.
- •Suspicion of acute COVID-19 infection
结局指标
主要结局
Analysis of demographic profile (Age) of recovered COVID-19 patients [at inclusion]
时间窗: At inclusion
Demographic profile included Age at presentation (in years)
Analysis of demographic profile (occupation) of recovered COVID-19 patients [at inclusion]
时间窗: At inclusion
Demographic profile included occupation at presentation (healthcare-worker/non-healthcare)
Analysis of associated co-morbidities in recovered COVID-19 patients [at inclusion]
时间窗: At inclusion
Participants completed a questionnaire with "Yes" or "no" for history of comorbidities namely: Asthma/seasonal allergies, Diabetes Mellitus, Hypertension, cardiovascular disease or any other co-morbidity (please specify).
Analysis of demographic profile (Gender) of recovered COVID-19 patients [at inclusion]
时间窗: At inclusion
Demographic profile included Sex (gender) at presentation (male/female/other)
Analysis of immunological profile recovered COVID-19 patients [at inclusion]
时间窗: At inclusion
The participants were questioned about their respective blood groups.
Seroprevalence of IgM and IgG against Nucleocapsid of SARS-CoV-2 (in AU/ml) [from T0 to T5]
时间窗: 8 months
From May 2020 to January 2021, anti-nucleocapsid (NCP) antibodies developed against SARS-CoV-2 were analysed using n-CoV IgM/IgG CLIA assay through sequential serological tests in n=30 patients. Time was treated as a factor and six time points were defined. The first blood sample was collected in May 2020 (2 months after infection) and was defined as T0. Consecutive samples were analysed at 3 months (T1), five months (T2) , seven months (T3) and eight months (T4) and ten months (T5) post infection in June, August, October, November of 2020 and January 2021 respectively.
Seroprevalence of IgM and IgG against spike-receptor binding domain of SARS-CoV-2 (in AU/ml) for vaccinated individuals
时间窗: through study completion, an average of 2 years
The vaccinated recovered individuals continued to report for follow-up for antibody analysis
Seroprevalence of IgM and IgG against spike-receptor binding domain of SARS-CoV-2 (in AU/ml) [from T6 to T8]
时间窗: through study completion, an average of 2 years
A more specific immunoassay (CLIA) against SARS-CoV-2 S-RBD was adopted for future assessments. From late February 2021, an additional n = 12 patients (8 female and 4 male), who met the eligibility criteria for participation, were enrolled in the study and added to the original cohort (n = 30). These patients (n=12), similar to the original cohort, had a history of testing positive for SARS-CoV-2 by RT-qPCR in March 2020, updating the sample size to n = 42. Since the legal provisions adopted by the Italian Ministry of Health advised mandatory vaccination for all Healthcare Workers, irrespective of previous disease status,n=10 patients (4 female, 6 male) were gradually vaccinated from mid-March 2021 and excluded from the original cohort, making the revised final sample size,n = 32.
Analysis of clinical profile of recovered COVID-19 patients [at inclusion]
时间窗: At inclusion
Clinical profile included clinical symptoms experienced at the time of presentation. The participant completed a questionnaire with "Yes" or "no" for each symptom. The symptoms were namely: Fever, Rhinorrhea, Dry cough, Sore throat, Shortness of breath, fatigue, Headche, Muscle ache, skin eruptions, diarrhoea, conjunctivitis, loss of smell, loss of taste, chest pain or any other symptom (please specify).
次要结局
- Co-relation of demographic profile with antibody titers against spike- RBD of SARS-CoV-2 with respect to disease severity [ Time Frame: at inclusion and within observational period ](4 months)
- Co-relation of demographic profile with antibody titers against NCP of SARS-CoV-2 with respect to disease severity [ Time Frame: at inclusion and within observational period ](8 months)
- Co-relation of symptoms and antibody titer levels against Nucleocapsid of SARS-CoV-2 with respect to disease severity [ Time Frame: at inclusion and within observational period ](at inclusion and within the observational period (8 months))
- Co-relation of co-morbidities and antibody titer levels with respect to disease severity [ at inclusion](at inclusion and within the observational period (through study completion, an average of 2 years))
- Co-relation of antibody titer levels and smell and taste dysfuntion with respect to disease severity [ at inclusion](at inclusion and within the observational period (through study completion, an average of 2 years))
- Co-relation of self reported symptoms and antibody titer levels against spike-RBD with respect to disease severity [ Time Frame: at inclusion and within observational period ](at inclusion and within the observational period (4 months))
研究者
Dr. Puya Dehgani Mobaraki
Principal Investigator
Association "Naso Sano" Onlus