Short-term Effects of Transdermal Estradiol on Female COVID-19 Patients
- Conditions
- Hormone Replacement TherapyCOVID-19
- Interventions
- Other: Hydrogel patch
- Registration Number
- NCT05774405
- Lead Sponsor
- Istanbul University - Cerrahpasa (IUC)
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 9169
- 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
- Negative RT-PCR test
- Female patients at reproductive stage
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Climara 0.1Mg/24Hr Transdermal System 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. Placebo Hydrogel patch 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.
- Primary Outcome Measures
Name Time Method Evidence of disease progression for mild cases 15 days Proportion of patients who are hospitalised in 15 days
Markers of coagulation 15 days change of fibrinogen (mg/dL) and D-dimer (mg/L) with estrogen and hydrogel patch application
Evidence of disease progression for moderate and severe cases 15 days Proportion of patients who required mechanical ventilation or died within 15 days
Platelet 15 days change of platelets in total blood count (\*10\^3/μL) with estrogen and hydrogel patch application
Kidney function tests 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 15 days change of C-reactive protein (mg/L) levels within 15 days
- Secondary Outcome Measures
Name Time Method serum E2 levels 15 days change of serum E2 levels with estrogen and hydrogel patch application
rate of death 15 days comparison of rate of death in each arm
rate of complications 15 days comparison of rate of complications in each arm
Trial Locations
- Locations (1)
Istanbul University-Cerrahpasa
🇹🇷Istanbul, Turkey