COVID-19Phase 2NCT05774405
Short-term Effects of Transdermal Estradiol on Female COVID-19 Patients
A Phase 2 study testing Climara 0.1Mg/24Hr Transdermal System and Hydrogel patch in people with COVID-19 and Hormone Replacement Therapy, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- COVID-19, Hormone Replacement Therapy
- What is being tested?
- Climara 0.1Mg/24Hr Transdermal System and Hydrogel patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9,169 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2020to 31 Jul 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Negative RT-PCR test
- Female patients at reproductive stage
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, 34098
About this study
Official title: Short-term Effects of Transdermal Estradiol on Female COVID-19 Patients: A Randomized Placebo-Controlled Study
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:
Read more
- 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
Read the 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.
- Conditions
- COVID-19, Hormone Replacement Therapy
- Being tested
- Climara 0.1Mg/24Hr Transdermal System, Hydrogel patch
- Keywords
- Covid-19, hormone replacement therapy
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Climara 0.1Mg/24Hr Transdermal SystemDrug
Transdermal estradiol patch is used.
Hydrogel patchOther
Adhesive Hydrogel patch
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Climara 0.1Mg/24Hr Transdermal System |
| Placebo | Placebo comparator | 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. Receives: Other: Hydrogel patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of disease progression for mild cases
Proportion of patients who are hospitalised in 15 days
Measured: 15 days
Evidence of disease progression for moderate and severe cases
Proportion of patients who required mechanical ventilation or died within 15 days
Measured: 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
Measured: 15 days
Platelet
change of platelets in total blood count (*10^3/μL) with estrogen and hydrogel patch application
Measured: 15 days
Markers of coagulation
change of fibrinogen (mg/dL) and D-dimer (mg/L) with estrogen and hydrogel patch application
Measured: 15 days
Marker of inflammation
change of C-reactive protein (mg/L) levels within 15 days
Measured: 15 days
Secondary outcomes (3)
serum E2 levels
change of serum E2 levels with estrogen and hydrogel patch application
Measured: 15 days
rate of death
comparison of rate of death in each arm
Measured: 15 days
rate of complications
comparison of rate of complications in each arm
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start1 Jul 2020
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9,169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Turkish Menopause and Osteoporosis Society, Karakoy Rotary Club, Rebul Pharmacy
- Responsible party
- Principal investigator, Cemal Tamer Erel, Istanbul University - Cerrahpasa
- Investigators
- Cemal Tamer Erel, Prof, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774405
- Sponsor's protocol ID
- 68871907-604.01.01-67414
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of Transdermal Estradiol on Female COVID-19 Patients: A Randomized Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT05774405
- Acronym / sponsor ID
- 68871907-604.01.01-67414
- Conditions
- COVID-19, Hormone Replacement Therapy
- Keywords
- Covid-19, hormone replacement therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9,169 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Turkish Menopause and Osteoporosis Society, Karakoy Rotary Club, Rebul Pharmacy
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Climara 0.1Mg/24Hr Transdermal SystemAll 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 | Placebo comparator | Other: Hydrogel patchAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Negative RT-PCR test
- Female patients at reproductive stage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Climara 0.1Mg/24Hr Transdermal SystemTransdermal estradiol patch is used. | Drug | Experimental |
| Hydrogel patchAdhesive Hydrogel patch | Other | Placebo |
Primary outcome
Evidence of disease progression for mild cases
Time frame: 15 days
Proportion of patients who are hospitalised in 15 days
Evidence of disease progression for moderate and severe cases
Time frame: 15 days
Proportion of patients who required mechanical ventilation or died within 15 days
Kidney function tests
Time frame: 15 days
change of urea(mg/dL), creatinine(mg/dL) and uric acid (mg/dL) levels with estrogen and hydrogel patch application
Platelet
Time frame: 15 days
change of platelets in total blood count (*10^3/μL) with estrogen and hydrogel patch application
Markers of coagulation
Time frame: 15 days
change of fibrinogen (mg/dL) and D-dimer (mg/L) with estrogen and hydrogel patch application
Marker of inflammation
Time frame: 15 days
change of C-reactive protein (mg/L) levels within 15 days
3 secondary outcomes
serum E2 levels
Time frame: 15 days
rate of death
Time frame: 15 days
rate of complications
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cemal Tamer Erel, Prof principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Climara 0.1Mg/24Hr Transdermal System and Hydrogel patch in people with COVID-19 and Hormone Replacement Therapy, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of disease progression for mild cases (time frame: 15 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.