Efficacy of Chloroquine Phosphate Prophylactic Use in First-line Health Personnel Exposed to COVID-19 Patients
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Negative Polymerase Chain Reaction assay at day 0
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy and security of chloroquine phosphate prophylactic use for reducing the risk of infection by severe acute respiratory syndrome coronavirus-2 in Health Care Workers exposed to COVID-19 patients.
详细描述
Health Care Workers as first line of hospital care, are at high risk of infection by severe acute respiratory syndrome coronavirus-2 due for the exposure to COVID-19 patients. The pharmacological treatment with chloroquine phosphate has emerged as one of the main therapeutic approaches for COVID-19 patients. However, some studies have described and hypothesized that the use of prophylactic chloroquine phosphate could provide some protection against COVID-19 infection reducing the chances of contagion in Health Care personnel during the development of the pandemic. A controlled clinical trial will be conducted in a tertiary hospital in Mexico City, Mexico. Participants will be divide in two groups; 1) intervention: who will receive chloroquine phosphate (300 mg/day during the first 30 days and 150mg/day during the last 30 days) and 2) control, both with a follow up for 60 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The Outcome Assessor will be an external member of the Internal Medicine Service, which will be blinded to the intervention.
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Health Care Workers as first line of hospital care exposed to COVID-19 patients.
- •Initial polymerase chain reaction assay negative test for severe acute respiratory syndrome coronavirus-2 infection.
- •Both sexes
- •Agree to participate in the study after signing an informed consent letter.
排除标准
- •Health Care Workers as first line of hospital care exposed to COVID-19 patients with history of heart disease, arrhythmias or QT segment prolongation.
- •Health Care Workers as first line of hospital care exposed to COVID-19 patients with liver or kidney disease of any etiology.
- •Health Care Workers as first line of hospital care exposed to COVID-19 patients with retinopathy of any etiology.
- •Health Care Workers as first line of hospital care exposed to COVID-19 patients with allergy to chloroquine.
- •Health Care Workers as first line of hospital care exposed to COVID-19 patients with a history or diagnosis of psoriasis.
- •Health Care Workers as first line of hospital care exposed to COVID-19 patients with important primary clinical alterations: renal (creatinine> 3), liver (Alanine Aminotransferase and Aspartate Aminotransferase x 3), endocrine, neurological.
研究组 & 干预措施
Chloroquine phosphate prophylactic group
Drug: Chloroquine phosphate
Dosage form, frequency and duration: 300 mg per day during initial 30 days and 150 mg per day during the next 30 days.
干预措施: Chloroquine phosphate (Drug)
结局指标
主要结局
Negative Polymerase Chain Reaction assay at day 0
时间窗: Day 0
Prior to the participation of each health worker, a pharyngeal exudate sample will be taken with a swab. RNA will be obtained by applying severe acute respiratory syndrome coronavirus-2 real time polymerase chain reaction kit, using specific oligonucleotides in polymerase chain reaction.
Polymerase Chain Reaction assay at day 60
时间窗: Day 60
A pharyngeal exudate sample will be taken with a swab. RNA will be obtained by applying severe acute respiratory syndrome coronavirus-2 real time polymerase chain reaction kit, using specific oligonucleotides in polymerase chain reaction.
次要结局
- Clinical improvement related to COVID-19(From 30-day to 60-day follow-up)
- Heart rhythm negative adverse event related to the Chloroquine Phosphate Prophylactic Use(Baseline (day 0) and 30-day follow up)
- Heart rhythm negative adverse event related to the Chloroquine Phosphate Prophylactic(From 30-day to 60-day follow-up)
- COVID-19 symptomatic onset rate(From baseline (day 0) to 60-day follow up)
研究者
Sandra Muñoz López
Internal Medicine Service Member, MD, MSc
CMN "20 de Noviembre"