Short-term Effects of Transdermal Estradiol on Female COVID-19 Patients

COVID-19 Clinical Trial

Official title:

Short-term Effects of Transdermal Estradiol on Female COVID-19 Patients: A Randomized Placebo-Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05774405
• Other study ID #: 68871907-604.01.01-67414
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: March 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 9169
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Hormone Replacement Therapy

Intervention

Drug:
• Climara 0.1Mg/24Hr Transdermal System
Transdermal estradiol patch is used.

Other:
• Hydrogel patch
Adhesive Hydrogel patch

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul

Sponsors (4)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)	Karakoy Rotary Club, Rebul Pharmacy, Turkish Menopause and Osteoporosis Society

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of disease progression for mild cases	Proportion of patients who are hospitalised in 15 days	15 days
Primary	Evidence of disease progression for moderate and severe cases	Proportion of patients who required mechanical ventilation or died within 15 days	15 days
Primary	Kidney function tests	change of urea(mg/dL), creatinine(mg/dL) and uric acid (mg/dL) levels with estrogen and hydrogel patch application	15 days
Primary	Platelet	change of platelets in total blood count (*10^3/µL) with estrogen and hydrogel patch application	15 days
Primary	Markers of coagulation	change of fibrinogen (mg/dL) and D-dimer (mg/L) with estrogen and hydrogel patch application	15 days
Primary	Marker of inflammation	change of C-reactive protein (mg/L) levels within 15 days	15 days
Secondary	serum E2 levels	change of serum E2 levels with estrogen and hydrogel patch application	15 days
Secondary	rate of death	comparison of rate of death in each arm	15 days
Secondary	rate of complications	comparison of rate of complications in each arm	15 days