Clinical Characterisation Protocol for COVID-19 in People Living With HIV
试验速览
- 阶段
- 不适用
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Describe the course of COVID-19 disease in patients infected with HIV,
研究概览
简要总结
There is very little data so far to determine whether people living with HIV (PLWHIV) are at greater risk of COVID-19 acquisition or severe disease. HIV infection is associated with deficiencies in both humoral and cell-mediated immunity that could potentially alter the course and severity of common infections. The investigators will study the correlation between clinical and immunovirological data. The singularity of this work is to have an in-depth immunovirological approach linked to the clinical characteristics in COVID-19 HIV co-infected patients. COVIDHIV is the only study to date to offer this combined approach in PLWHIV.
This protocol is a historical and prospective cohort study of PLWHIV presenting COVID-19 The primary objectives are to describe the course of COVID-19 disease in patients infected with HIV
详细描述
Infectious diseases are a major cause of death worldwide. Recently a new coronavirus named SARS-CoV-2 has been identified as responsible of an initial epidemic respiratory disease, named COVID-19, in China since the 31 December 20191. COVID-19 has developed into a pandemic, with small chains of transmission in many countries and large chains resulting in extensive spread in a some countries, such as Italy, Iran, South Korea, and Japan 2 . Most countries are likely to have spread of COVID-19, at least in the early stages, before any mitigation measures have an impact and the COVID -19 epidemic is gradually taking hold in France 3.
There is very little data so far to determine whether people living with HIV (PLWHIV) are at greater risk of COVID-19 acquisition or severe disease. HIV infection is associated with deficiencies in both humoral and cell-mediated immunity that could potentially alter the course and severity of common infections. Although use of cART partially restores immune system, HIV-infected persons may remain at increased risk for morbidity associated with viral illnesses, especially if the ability to generate antigen-specific responses remains impaired 5. Additional factors, such as the high prevalence of smoking and chronic lung diseases among such patients, may further predispose HIV-infected patients to respiratory tract infections. Finally, they could be considered more vulnerable to SARS-CoV-2 infection because their immune systems are already under strain and cannot avoid the possibility of atypical presentations in these patients. Thus, we would like to implement a research as soon as possible concerning PLWHIV in order to adapt the care of these patients as fast as possible.
The investigator will study the correlation between clinical and immunovirological data. The singularity of this work is to have an in-depth immunovirological approach linked to the clinical characteristics in COVID-19 HIV co-infected patients. COVIDHIV is the only study to date to offer this combined approach in PLWHIV.
This protocol is a historical and prospective cohort study of PLWHIV presenting COVID-19
The primary objectives are to describe the course of COVID-19 disease in patients infected with HIV-1, and more specifically to:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for the 250 patients with COVID19
- •Patient living with HIV (PLWHIV)
- •Patient with confirmed infection with SARS-CoV-2 since 1st January 2020 with and without criteria of hospitalisation.
- •Inclusion criteria for the 20 patients without COVID19 (who will only realize the qualitative interview)
- •Patient living with HIV (PLWHIV)
- •Patient who did not have COVID-19
排除标准
- •Exclusion criteria for the 250 patients with COVID19
- •Confirmed diagnosis of another pathogen than SARS-CoV-2
- •Refusal by participant, or appropriate representative.
- •Being under guardianship or trusteeship mandate for future protection
- •Participate to another study without consent of the promoter
- •Patients less than 18 years old
- •No Beneficiary or entitled to a social security scheme or state medical aid.
- •Exclusion criteria for the 20 patients without COVID19 (who will only realize the qualitative interview)
- •Refusal by participant, or appropriate representative.
- •Being under guardianship or trusteeship mandate for future protection
- •Participate to another study without consent of the promoter
- •Patients less than 18 years old
- •No Beneficiary or entitled to a social security scheme or state medical aid.
结局指标
主要结局
Describe the course of COVID-19 disease in patients infected with HIV,
时间窗: 6 months
Biological sample collection
次要结局
未报告次要终点