Correlation Between Cycle Threshold (Ct) Values in RT-PCR - SARS-CoV-2, Health Status and Laboratory Biomarkers in the Population of Medellin- Colombia Evaluated in a Specialized Laboratory
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Clinical immune response among COVID-19 patients related to CT value of rRT-PCR SARS-Cov-2
研究概览
简要总结
This study will evaluate the correlation between the symptomaticity, Ct value, laboratory biomarkers associated to COVID-19 and the disease progression in hospitalized patients and outpatients with SARS-CoV2 infection diagnosed by RT-PCR assay for nasopharyngeal swab specimens in a specialized laboratory at Medellin,Colombia.
详细描述
After being informed about the study, all patients giving written informed consent will undergo a serial of test related to COVID-19. Rh and blood type will be obtained using the Colombian ID card or official document.
All symptomatic and asymptomatic COVID19-positive patients will be evaluated for a period of 4 weeks at three different times of the study. In a single time, the mitochondrial DNA will be measured, and the variability in the CT value, hemogram, cytokine levels, ratio of CD4 + / CD8 + lymphocytes, levels of dehydrogenase lactate, ferritin and D-dimer, antibodies IgG and IgM, will be measured on day 5, day 14 and day 28. In addition, spike S protein sequencing and growing the virus in cell culture that meet specific criteria will be performed. A physician will do clinical follow up through the period of the study for each patient.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People under 18 years old.
- •Covid-19 diagnosis in the last seven days.
- •Specimen analyzed at LIME laboratory
- •Description of symptoms related to COVID-19
排除标准
- •Immunocompromised patients
- •Immunosuppressive treatments, chemotherapy or antiretroviral therapy
- •Outpatient anticoagulation therapy
- •Prior immunization for any vaccine in the last 3 months
结局指标
主要结局
Clinical immune response among COVID-19 patients related to CT value of rRT-PCR SARS-Cov-2
时间窗: Through study completion, an average of 4 months
Calculated Ct value over 4 weeks, comparing the change in the immune status through the measurement of biomarkers
次要结局
- Identification of polymorphic variants or mutations in COVID-19 patients(Through study completion, an average of 4 months)
- Mitochondrial DNA haplogroup relation in people infected with SARS CoV2(Through study completion, an average of 4 months)
- Determine the duration of the positivity of the PCR test in asymptomatic and symptomatic patients through the follow-up(Through study completion, an average of 4 months)
- Evaluate differences in the titers of immunoglobulins M and G against anti-RBD domain of the protein S in SARS-CoV2(Through study completion, an average of 4 months)
- Capacity of isolating the virus in cell culture with Ct> 32 by PCR in COVID-19 patients(Through study completion, an average of 4 months)
研究者
Andres Felipe Zuluaga Salazar
Full profesor, senior researcher and head of the Department of Pharmacology and Toxicology in Antioquia University
Universidad de Antioquia