Oestrogen Treatment for COVID-19 Symptoms
- Registration Number
- NCT04853069
- Lead Sponsor
- Hamad Medical Corporation
- Brief Summary
The aim of this trial is to determine whether oestrogen treatment mitigates disease progression and severity in confirmed COVID19.
- Detailed Description
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
.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2000
- 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)
Women:
- 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
Men:
• 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oestrogen Therapy Transdermal estradiol gel Patients will receive standard care + transdermal 17ß-estradiol gel (3 mg) for ten days.
- Primary Outcome Measures
Name Time Method Evidence of disease progression in hospitalised patients (moderate and severe cases) 28 days Proportion requiring mechanical ventilation or dying within 28 days
Evidence of disease progression for mild cases 28 days Proportion hospitalised within 28 days
- Secondary Outcome Measures
Name Time Method Ventilation 28 days Proportion requiring mechanical ventilation within 28 days
Hospital mortality 28 days Rate of mortality
Need for renal replacement therapy 28 days Proportion requiring renal replacement therapy
Duration of hospital admission 28 days Length of stay at hospital
Admission to ICU/ HDU facility 28 days Length of stay at ICU/HDU facility
Time to being fit for hospital discharge 28 days Time of discharge
Trial Locations
- Locations (1)
Hamad Medical Corporation
🇶🇦Doha, Qatar