COVID-19, Hormone Replacement Therapy
Conditions
Keywords
Covid-19, hormone replacement therapy
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.
Interventions
DRUGClimara 0.1Mg/24Hr Transdermal System
Transdermal estradiol patch is used.
OTHERHydrogel patch
Adhesive Hydrogel patch
Sponsors
Turkish Menopause and Osteoporosis Society
Karakoy Rotary Club
Rebul Pharmacy
Istanbul University - Cerrahpasa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Negative RT-PCR test * Female patients at reproductive stage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Marker of inflammation | 15 days | change of C-reactive protein (mg/L) levels within 15 days |
| 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 |
| Platelet | 15 days | change of platelets in total blood count (\*10\^3/μL) with estrogen and hydrogel patch application |
| 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 mild cases | 15 days | Proportion of patients who are hospitalised in 15 days |
| Evidence of disease progression for moderate and severe cases | 15 days | Proportion of patients who required mechanical ventilation or died within 15 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| serum E2 levels | 15 days | change of serum E2 levels with estrogen and hydrogel patch application |
| rate of complications | 15 days | comparison of rate of complications in each arm |
| rate of death | 15 days | comparison of rate of death in each arm |
Countries
Turkey (Türkiye)
Outcome results
None listed