Randomized, Double-blind, Placebo-controlled Trial of TAF/FTC for Pre-exposure Prophylaxis of COVID-19 in Healthcare Workers (CoviPrep Study)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1,378
- 试验地点
- 1
- 主要终点
- COVID-19 incident cases
研究概览
简要总结
A randomized parallel double-blinded placebo-controlled clinical trial to evaluate the effect of Emtricitabine/Tenofovir alafenamide (FTC/TAF) compared with placebo on the risk of developing SARS-CoV-2 disease (COVID-19) in healthcare workers with high transmission risk in addition to currently recommended control measures.
详细描述
Randomized, double-blind, placebo-controlled clinical trial. Phase III clinical trial for a new indication
Rationale One of the most affected subgroups during the current pandemic is represented by healthcare workers. In Argentina between 14 and 17% of the total COVID-19 cases are represented by this subgroup. In this sense, it appears as an adequate strategy testing the efficacy of pharmacological PrEP approaches on top of the currently recommended control measures.
The use of placebo is warranted for two main reasons: all healthcare workers will be allowed and encouraged to comply with non-pharmacological infection control measures for the protection of viral transmission. On the other hand, the use of a blinded placebo is intended for avoiding relaxation of the non-pharmacological control measures.
Tenofovir has been identified by both docking and in vitro studies as an inhibitor of RdRp (RNA dependent RNA polymerase) of coronavirus.
FTC/TAF has the additional advantage that is already being used in a pre-exposure prophylaxis setting and its safety is widely known.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The treatment will be the same in both arms: 1 tablet per day will be administered for a total of 12 weeks. Placebo and the active principle will be indistinguishable.
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
- •Healthcare workers voluntarily deciding to participate in the study
- •Understanding the study purpose
- •Having between 18 and 70 years old
- •Having a high transmission risk for Covid-
- •Physicians, nurses, lab technicians, physical therapists, or cleaning personnel working at COVID-19 areas, hospital emergency areas, or Intensive care units from healthcare institutions with the direct assistance of patients with Covid-
- •Not having a prior diagnosis of SARS-CoV-2 infection (COVID-19)
- •Having a negative IgM/IgG antibodies test for SARS-CoV-2 (COVID-19) prior to study entry
- •Negative pregnancy test for childbearing age women within 7 days prior to study entry.
- •Childbearing age males and females should comply with the use of a proven contraceptive method (double barrier methods, oral contraceptives or contraceptive hormone implants) during the course of the study and at least one month after study completion.
排除标准
- •Having symptoms compatible with COVID-19
- •Diagnosed HIV infection
- •Current use of Pre-exposure prophylaxis for HIV
- •Diagnosed Hepatitis B infection.
- •Diagnosed renal insufficiency and or current hemodialysis need
- •Diagnosed osteoporosis under pharmacological treatment.
- •Weight < 40kg
- •Current immunosuppressive or serious hematological condition
- •Prior use of pre-exposure prophylaxis for SARS-CoV-2
- •Current pregnancy or pregnancy plan within the study course.
- •Current breastfeeding
- •Known hypersensitivity to any of the study medication components.
研究组 & 干预措施
FTC/TAF
Emtricitabine/Tenofovir alafenamide (FTC/TAF) in 200 mg/25 mg tablets. A dose of 1 tablet per day will be administered for a total of 12 weeks.
干预措施: Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet (Drug)
Placebo
Identical tablets to the active experimental tablets with the same characteristics and packaging. A dose of 1 tablet per day will be administered for a total of 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
COVID-19 incident cases
时间窗: During treatment (12 weeks)
SARS-CoV-2 disease (COVID-19) with or without symptoms at week 12 of treatment as defined by the presence of specific antibodies against the virus. Positive cases will be confirmed by PCR
次要结局
- Relation between treatments and symptoms duration(During treatment (12 weeks))
- Number of asymptomatic SARS-CoV-2 (Covid-19) infections confirmed by serology(During treatment (12 weeks))
- Severity of symptomatic COVID-19(During treatment (12 weeks))
- Respiratory symptom duration in days(During treatment (12 weeks))
- Time course of specific IgM/IgG seroconversion(During treatment (12 weeks))
研究者
Waldo Horacio Belloso
Principal Investigator
Hospital Italiano de Buenos Aires