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

Primary Purpose

COVID-19, Hormone Replacement Therapy

Status
Completed
Phase
Phase 2
Locations
Turkey
Study Type
Interventional
Intervention
Climara 0.1Mg/24Hr Transdermal System
Hydrogel patch
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Covid-19, hormone replacement therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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 Exclusion Criteria: Negative RT-PCR test Female patients at reproductive stage

Sites / Locations

  • Istanbul University-Cerrahpasa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Evidence of disease progression for mild cases
Proportion of patients who are hospitalised in 15 days
Evidence of disease progression for moderate and severe cases
Proportion of patients who required mechanical ventilation or died within 15 days
Kidney function tests
change of urea(mg/dL), creatinine(mg/dL) and uric acid (mg/dL) levels with estrogen and hydrogel patch application
Platelet
change of platelets in total blood count (*10^3/μL) with estrogen and hydrogel patch application
Markers of coagulation
change of fibrinogen (mg/dL) and D-dimer (mg/L) with estrogen and hydrogel patch application
Marker of inflammation
change of C-reactive protein (mg/L) levels within 15 days

Secondary Outcome Measures

serum E2 levels
change of serum E2 levels with estrogen and hydrogel patch application
rate of death
comparison of rate of death in each arm
rate of complications
comparison of rate of complications in each arm

Full Information

First Posted
March 15, 2023
Last Updated
March 23, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Turkish Menopause and Osteoporosis Society, Karakoy Rotary Club, Rebul Pharmacy
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1. Study Identification

Unique Protocol Identification Number
NCT05774405
Brief Title
Short-term Effects of Transdermal Estradiol on Female COVID-19 Patients
Official Title
Short-term Effects of Transdermal Estradiol on Female COVID-19 Patients: A Randomized Placebo-Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Turkish Menopause and Osteoporosis Society, Karakoy Rotary Club, Rebul Pharmacy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Hormone Replacement Therapy
Keywords
Covid-19, hormone replacement therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
9169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Climara 0.1Mg/24Hr Transdermal System
Intervention Description
Transdermal estradiol patch is used.
Intervention Type
Other
Intervention Name(s)
Hydrogel patch
Intervention Description
Adhesive Hydrogel patch
Primary Outcome Measure Information:
Title
Evidence of disease progression for mild cases
Description
Proportion of patients who are hospitalised in 15 days
Time Frame
15 days
Title
Evidence of disease progression for moderate and severe cases
Description
Proportion of patients who required mechanical ventilation or died within 15 days
Time Frame
15 days
Title
Kidney function tests
Description
change of urea(mg/dL), creatinine(mg/dL) and uric acid (mg/dL) levels with estrogen and hydrogel patch application
Time Frame
15 days
Title
Platelet
Description
change of platelets in total blood count (*10^3/μL) with estrogen and hydrogel patch application
Time Frame
15 days
Title
Markers of coagulation
Description
change of fibrinogen (mg/dL) and D-dimer (mg/L) with estrogen and hydrogel patch application
Time Frame
15 days
Title
Marker of inflammation
Description
change of C-reactive protein (mg/L) levels within 15 days
Time Frame
15 days
Secondary Outcome Measure Information:
Title
serum E2 levels
Description
change of serum E2 levels with estrogen and hydrogel patch application
Time Frame
15 days
Title
rate of death
Description
comparison of rate of death in each arm
Time Frame
15 days
Title
rate of complications
Description
comparison of rate of complications in each arm
Time Frame
15 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cemal Tamer Erel, Prof
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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