Observational Trial Evaluating the Serologic Status of Household Contacts of Patients Diagnosed With COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Identify antibodies
研究概览
简要总结
SARS-CoV-2 has now crossed the 1 million number of cases and tens of thousands of deaths. It´s R0 has been calculated between 2 and 5.7 solely based on clinical symptoms but it is estimated to likely be higher. Serologic evidence of infection has not been analyzed.
详细描述
Transverse, observational and descriptive study involving household contacts of documented patients with COVID-19 infection: contacts will be invited to participate and a blood sample will be drowned: IgM and IgG qualitative and quantitative measurements will be performed. Demographic data regarding age, comorbidities, calculated time spent before and after the patients diagnosis, isolation practices etc.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Persons over 1 years of age.
- •.Meet COVID-19 confirmed case intradomestic contact definition:
- •Living in the same home as the patient with SARS-CoV-2 PCR test detected (nasopharyngeal and/or oropharyngeal swab) performed in the Acute Respiratory Infection Diagnostic Unit.
- •Living in the same home as the patient with a PCR test for SARS-CoV-2 Indeterminate (nasopharyngeal and/or oropharyngeal swab) performed in the Acute Respiratory Infection Diagnostic Unit and that the initial patient has positive IgM/IgG serology for SARS-CoV-
- •.Informed Consent.
排除标准
- •.Have fever, cough, pharyngeal pain or clinically have symptoms compatible with COVID-19 at the time of recruitment.
- •.Autoimmune disease, cancer, neutropenia.
- •.Under 1 years of age.
- •.Patients who, in the investigator's opinion, should be excluded from the research protocol.
结局指标
主要结局
Identify antibodies
时间窗: 1 day
Identify the presence of IgM and IgG antibodies from intradomestic contacts of patients with Polymerase Chain Reaction for detected SARS-CoV-2 .
次要结局
- IgM determination(1 day)
- Determine antibody sensitivity(1 day)
- IgG determination(1 day)
研究者
Dr. Adrian Camacho-Ortiz
Head of the Infectious Disease Department
Hospital Universitario Dr. Jose E. Gonzalez