Prevention of COVID19 Infection by the Administration of Hydroxychloroquine to Institutionalized Older People and Nursing Home Staff. Controlled Clinical Trial, Randomized Triple Blind by Clusters (PREVICHARM Study)
试验速览
- 阶段
- 2 期
- 入组人数
- 1,930
- 主要终点
- SARS-CoV-2 infection in nursing home staff who provide direct care at 28 days
研究概览
简要总结
Professionals and residents of nursing homes are one of the most vulnerable groups in this public health crisis of COVID-19, since they have the highest rate of positives for COVID-19, despite the restriction measures carried out, such as prohibition of family visits to these centers, the infection occurs by cross transmission with the care staff of the centers, or with other residents.
At the moment, there are no clinical trials to test the hypothesis that hydroxychloroquine is effective in coronavirus treatment. Although what has been observed is a better prognosis in infected patients, since this drug inhibits the replication of the virus and its expansion to other tissues.
This study is a clinical trial to test the effectiveness of hydroxychloroquine as a preventive drug for SARS-CoV-2 infection. This drug will be applied to 1050 people residing in nursing home care and 880 professionals who work in close contact with these people and who have not yet contracted the infection.
This project will be carried out in the territories of Madrid, Navarra, Aragon and Andalusia (Spain).
Hydroxychloroquine is a widely known drug that is used in two scenarios, against autoimmune diseases, such as lupus or rheumatoid arthritis, and as an antimalarial drug.
It is also intended to demonstrate that the presumed reduction in viral load that would be obtained with hydroxychloroquine prophylaxis, would have no effect in development of immunity against the virus. This fact can create a new paradigm for the de-escalation of the confinement to which the population has been subjected to stop the virus spread, allowing the development of general immunity in controlled populations until reaching total immunity.
In addition to testing the effect of this drug, a non-pharmacological intervention based on a safety record will be tested in the management of infection on nursing home, to assess its effectiveness in detecting risk areas or bad practices carried out in this vulnerable environment.
The study is led by researchers of the Institute of Biomedicine of Malaga (Spain), and has obtained a financing of 1,024,199 euros from Carlos III Health Institute (Spain).
The period of execution of the clinical trial is one year, and with this intervention, the intention is to reduce cross-infection in residents by a minimum threshold of 15%, as well as to decrease infection in the professionals.
详细描述
The objective of this study is to evaluate the effectiveness of hydroxychloroquine chemoprophylaxis in healthcare personnel and residents:
- the incidence of secondary cases of SARS-CoV-2 infection in residents
- the incidence of SARS-CoV-2 infection in the staff. To assess the effect of measures to promote infection control. Design: Controlled, randomized, triple-blind cluster multicentre trial. Subjects: Institutionalized older people and nursing homes staff in four Autonomous Communities.
Sample: 880 professionals, 1050 residents in 84 residences. They will be given 800mg of hydorxychloroquine the first day and 400mg in the subsequent four days. Nasopharyngeal exudate will be taken for baseline RT-PCR, and at six and 14 days after the adminsitration of hydroxychloroquine.
Mortality, compliance, safety, symptoms, and hospital admission will be evaluated secondarily.
The highest risk group for SARS-CoV-2 infection is that of people over 60 years of age, with cardiovascular disease, diabetes, COPD and immunosuppression, reaching up to 32% of those infected. But, in addition, the impact is especially insidious among institutionalized older people. The Spanish MInistry of Health has developed some regulations with measures to curb the impact in this context. WHO places institutionalized people as a very vulnerable group due to their permanent close contact with other people in the residence, the abundance of group activities, the presence of people with cognitive impairment and the need for help for their activities of daily living, which involves close physical contact with healthcare personnel. Even the interventions for preventing and controlling the infection could seriously affect the mental health and well-being of this vulnerable people, even if they do not contract the infection. In the province of Malaga (Spain), a checklist has been developed consisting of 13 items related to knowledge and compliance with the rules of prevention, self-protection, isolation and circuits, carried out by case management nurses. This instrument contains many of the WHO recommendations and may be an element that could make a difference in this context.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The HCQ and the placebo will be manufactured by Laboratorios Rubio, blinded in similar containers for HCQ and placebo and will be stored in the pharmacy of the participating reference hospitals and will be distributed to the participating residences by the research technicians hired for the project.
A record of doses delivered and monitoring of doses consumed will be carried out. The containers must be wrapped in a disposable protective cover, which can be removed before entering the residences, in order to minimize the accidental transmission of the virus through this route.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Institutionalized people in nurswing homes since the beginning of the COVID19 epidemic who do not have the infection present at the time of entering into the study.
- •Healthcare professionals who provide direct care (nursing assistants and registered nurses) to institutionalized older people in nursing homes with confirmed cases of COVID19 during the past 8 days.
- •Subjects that give their consent to participate in the study or that it be obtained from their representative / legal guardian.
排除标准
- •Staff members who do not provide direct care to residents.
- •Residents with active SARS-CoV-2 infection present, or with symptoms compatible with COVID19 confirmed by PCR test.
- •Staff members with present or past SARS-CoV-2 infection, or with PCR-confirmed symptoms consistent with COVID
- •History of QT interval prolongation or arrhythmias of any etiology.
- •Presence of retinopathy of any etiology, changes in acuity or visual field.
- •Severe hearing loss (requires the use of hearing aids).
- •Structural heart disease.
- •History of non-structural heart failure, ischemic heart disease, SCASEST, or SCACEST
- •Chronic liver disease.
- •Alcoholism.
- •Epilepsy.
- •For the participating professionals, pregnancy or suspected pregnancy (if they are planning pregnancy, or in fertilizer treatment, they must abandon the study).
- •Subjects with known HDQ hypersensitivity.
- •Subjects diagnosed with G6PDH deficiency.
- •Taking other medicines that prolong QT: domperidone, ondansetron, cilostazol, antiarrhythmics (procainamide, amiodarone, flecainide, sotalol), macrolides (azithromycin, clarithromycin, erythromycin), quinolones (ciprofloxacin,), moxofloxacin,) neuroleptics (haloperidol, chlorpromazine, pimozide), antidepressants (citalopram, escitalopram), sulpiride, anticholinesterase drugs (donepezil)
- •Denial to participate in the study
研究组 & 干预措施
Intervention
The dose to be used as chemoprophylaxis will be 800mg of Hydroxychloroquine (HCQ) on the first day and 400mg during the subsequent four days. Participating subjects will be followed up at 6, 14 and 28 days.
干预措施: Hydroxychloroquine Only Product in Oral Dose Form (Drug)
结局指标
主要结局
SARS-CoV-2 infection in nursing home staff who provide direct care at 28 days
时间窗: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine
Dichotomous categorical variable
Number of secondary cases of SARS-CoV2 infection among residents at 28 days
时间窗: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine
Discrete quantitative variable. Residents with active viral load (diagnosed by polymerase chain reaction test) will be considered infected.
SARS-CoV-2 infection in nursing home staff who provide direct care at 14 days
时间窗: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine
Dichotomous categorical variable
Number of secondary cases of SARS-CoV2 infection among residents at six days
时间窗: This outcome will be evaluated at six days from the administration of chemoprophylaxis with hydroxychloroquine
Discrete quantitative variable. Residents with active viral load (diagnosed by polymerase chain reaction test) will be considered infected.
Number of secondary cases of SARS-CoV2 infection among residents at 14 days
时间窗: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine
Discrete quantitative variable. Residents with active viral load (diagnosed by polymerase chain reaction test) will be considered infected.
SARS-CoV-2 infection in nursing home staff who provide direct care at six days
时间窗: This outcome will be evaluated at six days from the administration of chemoprophylaxis with hydroxychloroquine
Dichotomous categorical variable
次要结局
- Mortality(This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine)
- Hospitalization(This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine)
- Symptoms of SARS-CoV-2 infection at six days(This outcome will be evaluated at 6 days from the administration of chemoprophylaxis with hydroxychloroquine)
- Compliance with treatment(It will be evaluated during the five days that the chemoprophylaxis with hydorxychloroquine is administered)
- Symptoms of SARS-CoV-2 infection at 14 days(This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine)
- Symptoms of SARS-CoV-2 infection at 28 days(This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine)
- Adverse events at 14 days(This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine)
- Adverse events at six days(This outcome will be evaluated at six days from the administration of chemoprophylaxis with hydroxychloroquine)
- Adverse events at 28 days(This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine)
研究者
JOSE MIGUEL MORALES ASENCIO
Professor of Research Methods and Evidence Based Health Care at University of Málaga (Spain)
University of Malaga