The Impact of Oestrogen Administration on Covid-19 Disease
试验速览
- 阶段
- 2 期
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Evidence of disease progression in hospitalised patients (moderate and severe cases)
研究概览
简要总结
The aim of this trial is to determine whether oestrogen treatment mitigates disease progression and severity in confirmed COVID19.
详细描述
It is known that (i) women are relatively protected from the impacts of other respiratory viruses, and that oestrogen may partly mediate this effect (ii) Oestrogen protects rodents from SARS-CoV-1 related mortality (iii) Women are relatively protected from developing or dying from severe COVID-19 and (iv) Postmenopausal women taking oestrogen replacement appear less likely to suffer Covid19-related critical illness. These effects may be mediated through oestrogen-related immunomodulation. In addition, however, 17β estradiol reduces expression of ACE2 (the receptor protein through which SARS-CoV-2 gains cellular entry) in tissues such as the kidney. As such, supplemental oestrogen may represent an effective therapy for Covid19.
We will randomise adult men and postmenopausal women with confirmed Covid19 disease to receive 10 days of transdermal oestrogen (3mg/day). The primary endpoint will be evidence of disease progression, indicated by hospitalisation (mild cases) or need for mechanical ventilation or death within 28 days of randomisation for those hospiatlsied. Secondary outcomes will include hospital mortality, duration of hospital admission, admission to ICU/ HDU facility, ICU/ HDU length of stay, need for renal replacement therapy, receipt and duration of invasive mechanical ventilation, cause-specific mortality and time to being fit for hospital discharge
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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
- None
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
- •Acute Covid-19 disease (PCR-confirmed or clinically diagnosed with high certainty)
- •Adult males > 18 years of age OR
- •Post-menopausal women (spontaneous amenorrhoea for >12 months in the absence of any other cause)
排除标准
- •taking oestrogen supplements or oestrogen receptor antagonists
- •with abnormal genital bleeding
- •with a history of breast cancer
- •with a history of endometrial or ovarian cancer
- •with untreated endometrial hyperplasia
- •taking hormone therapies (e.g. for prostate cancer)
- •Any subject:
- •failure to obtain consent
- •taking lamotrigine
- •with a thromboembolic disorder (e.g. Protein C or Protein S deficiency, antithrombin III deficiency)
- •with pre-existing liver or renal disease
- •with known allergy to exogenous oestrogens
- •with a history of porphyria
- •with a history of thromboembolic event including deep vein thrombosis, thromboembolic stroke or pulmonary emboli
- •taking part in another interventional clinical trial
研究组 & 干预措施
Oestrogen Therapy
Patients will receive standard care + transdermal 17ß-estradiol gel (3 mg) for ten days.
干预措施: Transdermal estradiol gel (Drug)
结局指标
主要结局
Evidence of disease progression in hospitalised patients (moderate and severe cases)
时间窗: 28 days
Proportion requiring mechanical ventilation or dying within 28 days
Evidence of disease progression for mild cases
时间窗: 28 days
Proportion hospitalised within 28 days
次要结局
- Ventilation(28 days)
- Hospital mortality(28 days)
- Need for renal replacement therapy(28 days)
- Duration of hospital admission(28 days)
- Admission to ICU/ HDU facility(28 days)
- Time to being fit for hospital discharge(28 days)