Short-term Effects of Transdermal Estradiol on Female COVID-19 Patients: A Randomized Placebo-Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9,169
- 试验地点
- 1
- 主要终点
- Evidence of disease progression for mild cases
研究概览
简要总结
The goal of this randomized placebo-controlled study is to investigate the short-term effects of transdermal estrogen therapy on postmenopausal women with COVID-19 disease.
The main question[s] it aims to answer are:
- the clinical outcomes with adding estrogen treatment to conventional therapy of Covid-19 disease
- the biochemical outcomes with adding estrogen treatment to conventional therapy of Covid-19 disease
All participants received favipiravir for a week according to the national guidelines published by the Health Ministry of Turkish Republic at that time.
As an intervention, transdermal estradiol patch (7.8 mg patch/week) was applied for 14 days on the upper buttock of the patients in experimental arm. As a placebo, hydrogel patch (adhesive hydrogel patch/week) was applied to the female patients for 14 days.
Researchers compared experimental and control groups to see if the impact of adding estrogen on the clinical course of Covid-19 disease
详细描述
The risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, morbidity and mortality from Covid-19 disease were higher among men compared to women. This is caused by the differences in immunological response and viral pathogenesis between men and women. It is theoretically assumed that estrogen has a positive impact on female COVID-19 patients. In this randomized placebo-controlled study, we aimed to investigate the short-term effects of transdermal estrogen therapy on postmenopausal women with COVID-19 disease. Female patients diagnosed with Covid-19 disease were examined and only postmenopausal women were included into the study. The COVID-19 diagnosis was made with a positive reverse transcription-polymerase chain reaction (RT-PCR) test given with nasal and oral swabs. All participants received favipiravir for a week according to the national guidelines published by the Health Ministry of Turkish Republic at that time.
As an intervention, transdermal estradiol patch (7.8 mg patch/week) was applied for 14 days on the upper buttock of the patients in experimental arm. As a placebo, hydrogel patch (adhesive hydrogel patch/week) was applied to the female patients for 14 days.
Our primary outcome was to achieve better clinical and biochemical outcomes with adding estrogen treatment to conventional therapy of Covid-19 disease. The epidemiological and clinical data, the results of biochemical analysis, the information regarding the treatment and outcomes and serum estradiol levels were determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients diagnosed with Covid-19 disease
- •Postmenopausal women (who had 12 months of amenorrhea after their final menstrual period)
- •Positive reverse transcription-polymerase chain reaction (RT-PCR) test given with nasal and oral swabs
排除标准
- •Negative RT-PCR test
- •Female patients at reproductive stage
研究组 & 干预措施
Experimental
All patients were treated with favipiravir for a week. At the same time, the patients in this arm received Estradiol patch (Climara 7.8 mg patch/week, Bayer, Germany) for 14 days.
干预措施: Climara 0.1Mg/24Hr Transdermal System (Drug)
Placebo
All patients were treated with favipiravir for a week. At the same time, the patients in this arm received Hydrogel patch (Adhesive Hydrogel patch/week, Rebul Pharmacy, Turkey) for 14 days.
干预措施: Hydrogel patch (Other)
结局指标
主要结局
Evidence of disease progression for mild cases
时间窗: 15 days
Proportion of patients who are hospitalised in 15 days
Markers of coagulation
时间窗: 15 days
change of fibrinogen (mg/dL) and D-dimer (mg/L) with estrogen and hydrogel patch application
Platelet
时间窗: 15 days
change of platelets in total blood count (\*10\^3/μL) with estrogen and hydrogel patch application
Evidence of disease progression for moderate and severe cases
时间窗: 15 days
Proportion of patients who required mechanical ventilation or died within 15 days
Kidney function tests
时间窗: 15 days
change of urea(mg/dL), creatinine(mg/dL) and uric acid (mg/dL) levels with estrogen and hydrogel patch application
Marker of inflammation
时间窗: 15 days
change of C-reactive protein (mg/L) levels within 15 days
次要结局
- serum E2 levels(15 days)
- rate of death(15 days)
- rate of complications(15 days)
研究者
Cemal Tamer Erel
Clinical Professor
Istanbul University - Cerrahpasa (IUC)