COVID-19Phase 2NCT04853069
Oestrogen Treatment for COVID-19 Symptoms
A Phase 2 study testing Transdermal estradiol gel in people with COVID-19, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
The aim of this trial is to determine whether oestrogen treatment mitigates disease progression and severity in confirmed COVID19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Transdermal estradiol gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteQatar
- Study dates
- 17 May 2021to 31 Mar 2022
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute Covid-19 disease (PCR-confirmed or clinically diagnosed with high certainty)
- Adult males > 18 years of age OR
- Post-menopausal women (spontaneous amenorrhoea for >12 months in the absence of any other cause)
Who cannot join
- Women:
- taking oestrogen supplements or oestrogen receptor antagonists
- with abnormal genital bleeding
- with a history of breast cancer
- with a history of endometrial or ovarian cancer
- with untreated endometrial hyperplasia
Show all 17Show fewer
- Men:
- taking hormone therapies (e.g. for prostate cancer)
- Any subject:
- failure to obtain consent
- taking lamotrigine
- with a thromboembolic disorder (e.g. Protein C or Protein S deficiency, antithrombin III deficiency)
- with pre-existing liver or renal disease
- with known allergy to exogenous oestrogens
- with a history of porphyria
- with a history of thromboembolic event including deep vein thrombosis, thromboembolic stroke or pulmonary emboli
- taking part in another interventional clinical trial
Trial locations and contacts
1 site in 1 country.
Qatar1 site
Hamad Medical Corporation
Doha, PO Box 3050
Adel Ganaw, MD
Michael P Frenneaux, MD
About this study
Official title: The Impact of Oestrogen Administration on Covid-19 Disease
The aim of this trial is to determine whether oestrogen treatment mitigates disease progression and severity in confirmed COVID19.
Read the detailed description
It is known that (i) women are relatively protected from the impacts of other respiratory viruses, and that oestrogen may partly mediate this effect (ii) Oestrogen protects rodents from SARS-CoV-1 related mortality (iii) Women are relatively protected from developing or dying from severe COVID-19 and (iv) Postmenopausal women taking oestrogen replacement appear less likely to suffer Covid19-related critical illness. These effects may be mediated through oestrogen-related immunomodulation. In addition, however, 17β estradiol reduces expression of ACE2 (the receptor protein through which SARS-CoV-2 gains cellular entry) in tissues such as the kidney. As such, supplemental oestrogen may represent an effective therapy for Covid19.
We will randomise adult men and postmenopausal women with confirmed Covid19 disease to receive 10 days of transdermal oestrogen (3mg/day). The primary endpoint will be evidence of disease progression, indicated by hospitalisation (mild cases) or need for mechanical ventilation or death within 28 days of randomisation for those hospiatlsied. Secondary outcomes will include hospital mortality, duration of hospital admission, admission to ICU/ HDU facility, ICU/ HDU length of stay, need for renal replacement therapy, receipt and duration of invasive mechanical ventilation, cause-specific mortality and time to being fit for hospital discharge
.
- Conditions
- COVID-19
- Being tested
- Transdermal estradiol gel
- Keywords
- COVID-19, Oestrogen
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal estradiol gelDrug
Also called oestrogel, estrogel
Patients will receive standard care +/- (randomsed 1:1) transdermal 17ß-estradiol gel (3 mg; applied to forearm, upper arm and shoulder) for ten days.
| Study group | Role | What they receive |
|---|---|---|
| Oestrogen Therapy | Active comparator | Patients will receive standard care + transdermal 17ß-estradiol gel (3 mg) for ten days. Receives: Drug: Transdermal estradiol gel |
| Control Group | No intervention | Patients will receive only standard care. |
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 hospitalised within 28 days
Measured: 28 days
Evidence of disease progression in hospitalised patients (moderate and severe cases)
Proportion requiring mechanical ventilation or dying within 28 days
Measured: 28 days
Secondary outcomes (6)
Hospital mortality
Rate of mortality
Measured: 28 days
Duration of hospital admission
Length of stay at hospital
Measured: 28 days
Admission to ICU/ HDU facility
Length of stay at ICU/HDU facility
Measured: 28 days
Need for renal replacement therapy
Proportion requiring renal replacement therapy
Measured: 28 days
Ventilation
Proportion requiring mechanical ventilation within 28 days
Measured: 28 days
Time to being fit for hospital discharge
Time of discharge
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start17 May 2021 (estimated)
- Primary completion28 Feb 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe 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
- Model description
- Open label, randomized controlled trial, with patients randomized 1:1 to usual care, or usual care + oestrogen therapy. Prior to enrolment, an online CRF will be completed which will confirm that the patient meets the inclusion and exclusion criteria. Randomisation will be undertaken by the statistician in Qatar. Separate randomisation codes will be allocated for patients in Qatar and those in India, and separate randomisation will be performed for males and females. Randomisation will be enclosed in sequentially numbered sealed envelopes (with separate envelopes for males and females). Patients will be allocated to either the treatment or control group.
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Laboratoires Besins International
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853069
- Sponsor's protocol ID
- MRC-05-099
- Status last verified
- Mar 2021
- First submitted
- 6 Apr 2021
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ganaw A, Griffiths K, Ehfeda M, Elmalik A, Varghese M, Al Maslamani M, Chandra P, Montgomery H, Madhani M. Transdermal 17beta-Estradiol for the Treatment of COVID-19: Protocol of an Early Terminated Phase 2 Randomized Controlled Trial. JMIR Res Protoc. 2026 Sep 11;15:e81541. doi: 10.2196/81541.
PubMed 42726800
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Oestrogen Administration on Covid-19 Disease
- ClinicalTrials.gov ID
- NCT04853069
- Acronym / sponsor ID
- MRC-05-099
- Conditions
- COVID-19
- Keywords
- COVID-19, Oestrogen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Laboratoires Besins International
- Study start
- 17 May 2021 (estimated)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 21 Apr 2021 (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 aim of this trial is to determine whether oestrogen treatment mitigates disease progression and severity in confirmed COVID19.
Detailed description
It is known that (i) women are relatively protected from the impacts of other respiratory viruses, and that oestrogen may partly mediate this effect (ii) Oestrogen protects rodents from SARS-CoV-1 related mortality (iii) Women are relatively protected from developing or dying from severe COVID-19 and (iv) Postmenopausal women taking oestrogen replacement appear less likely to suffer Covid19-related critical illness. These effects may be mediated through oestrogen-related immunomodulation. In addition, however, 17β estradiol reduces expression of ACE2 (the receptor protein through which SARS-CoV-2 gains cellular entry) in tissues such as the kidney. As such, supplemental oestrogen may represent an effective therapy for Covid19.
We will randomise adult men and postmenopausal women with confirmed Covid19 disease to receive 10 days of transdermal oestrogen (3mg/day). The primary endpoint will be evidence of disease progression, indicated by hospitalisation (mild cases) or need for mechanical ventilation or death within 28 days of randomisation for those hospiatlsied. Secondary outcomes will include hospital mortality, duration of hospital admission, admission to ICU/ HDU facility, ICU/ HDU length of stay, need for renal replacement therapy, receipt and duration of invasive mechanical ventilation, cause-specific mortality and time to being fit for hospital discharge
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, randomized controlled trial, with patients randomized 1:1 to usual care, or usual care + oestrogen therapy. Prior to enrolment, an online CRF will be completed which will confirm that the patient meets the inclusion and exclusion criteria. Randomisation will be undertaken by the statistician in Qatar. Separate randomisation codes will be allocated for patients in Qatar and those in India, and separate randomisation will be performed for males and females. Randomisation will be enclosed in sequentially numbered sealed envelopes (with separate envelopes for males and females). Patients will be allocated to either the treatment or control group.
| Arm | Type | Receives |
|---|---|---|
| Oestrogen Therapy | Active comparator | Drug: Transdermal estradiol gelPatients will receive standard care + transdermal 17ß-estradiol gel (3 mg) for ten days. |
| Control Group | No intervention | –Patients will receive only standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute Covid-19 disease (PCR-confirmed or clinically diagnosed with high certainty)
- Adult males > 18 years of age OR
- Post-menopausal women (spontaneous amenorrhoea for >12 months in the absence of any other cause)
Key exclusion criteria (17 listed)
- taking oestrogen supplements or oestrogen receptor antagonists
- with abnormal genital bleeding
- with a history of breast cancer
- with a history of endometrial or ovarian cancer
- with untreated endometrial hyperplasia
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 |
|---|---|---|
| Transdermal estradiol gelAlso: oestrogel, estrogelPatients will receive standard care +/- (randomsed 1:1) transdermal 17ß-estradiol gel (3 mg; applied to forearm, upper arm and shoulder) for ten days. | Drug | Oestrogen Therapy |
Primary outcome
Evidence of disease progression for mild cases
Time frame: 28 days
Proportion hospitalised within 28 days
Evidence of disease progression in hospitalised patients (moderate and severe cases)
Time frame: 28 days
Proportion requiring mechanical ventilation or dying within 28 days
6 secondary outcomes
Hospital mortality
Time frame: 28 days
Duration of hospital admission
Time frame: 28 days
Admission to ICU/ HDU facility
Time frame: 28 days
Need for renal replacement therapy
Time frame: 28 days
Ventilation
Time frame: 28 days
Time to being fit for hospital discharge
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Derived from this study: PubMed 42726800Ganaw A, Griffiths K, Ehfeda M, Elmalik A, Varghese M, Al Maslamani M, Chandra P, Montgomery H, Madhani M. Transdermal 17beta-Estradiol for the Treatment of COVID-19: Protocol of an Early Terminated Phase 2 Randomized Controlled Trial. JMIR Res Protoc. 2026 Sep 11;15:e81541. doi: 10.2196/81541.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
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 Transdermal estradiol gel in people with COVID-19, run by Hamad Medical Corporation at 1 site in Qatar.
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 17 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: status not confirmed, as of the sponsor's last update on 21 Apr 2021. 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 Qatar. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael P Frenneaux (0097455425733, MFrenneaux@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of disease progression for mild cases (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04853069, which also lists 1 linked publication.
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 21 Apr 2021.