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

Sponsor

Istanbul University - Cerrahpasa (IUC) (Other)

Overall Status

Completed

CT.gov ID

NCT05774405

Collaborator

Turkish Menopause and Osteoporosis Society (Other), Karakoy Rotary Club (Other), Rebul Pharmacy (Other)

9,169

Enrollment

Location

Arms

Actual Duration (Months)

706.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Hormone Replacement Therapy	Drug: Climara 0.1Mg/24Hr Transdermal System Other: Hydrogel patch	Phase 2

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.

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

9169 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2020

Actual Primary Completion Date :

Jul 31, 2021

Actual Study Completion Date :

Jul 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental 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.	Drug: Climara 0.1Mg/24Hr Transdermal System Transdermal estradiol patch is used.
Placebo Comparator: Placebo 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.	Other: Hydrogel patch Adhesive Hydrogel patch

Arm

Intervention/Treatment

Experimental: Experimental

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.

Drug: Climara 0.1Mg/24Hr Transdermal System

Transdermal estradiol patch is used.

Placebo Comparator: Placebo

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.

Other: Hydrogel patch

Adhesive Hydrogel patch

Outcome Measures

Primary Outcome Measures

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
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
Marker of inflammation [15 days]
change of C-reactive protein (mg/L) levels within 15 days

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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