COVIDPhase 2NCT04359329
Estrogen Patch for COVID-19 Symptoms
A Phase 2 study testing Estradiol patch in people with COVID, run by Sharon Nachman at 1 site in United States.
Trial summary
The purpose of this study is to find out if estrogen, a female sex hormone, given as a patch placed on skin of COVID19 positive or presumptive positive patients for 7 days can reduce the severity of COVID19 symptoms compared to regular care. This study has two study groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID
- What is being tested?
- Estradiol patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2020to 30 Jul 2020
- 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
- Male ≥ 18 years of age or female ≥ 55 years of age
- Documentation of COVID19 positivity or the presence of one or more of the following new onset (<7 days) clinical features defining presumptive COVID19
- fever of >100.5°F or 38°C
- shortness of breath
- cough
- radiologic evidence of pneumonia
- Able to provide informed consent
- Able to be contacted by telephone for follow-up
Who cannot join
- Currently receiving estrogen based hormonal therapy
- Abnormal genital bleeding
- Protein C or Protein S deficiency
- Pre-existing liver impairment (e.g. Hepatitis C, cirrhosis)
- History of anaphylactic reaction or angioedema with Climara
- Receiving lamotrigine therapy
Show all 13Show fewer
- Subjects with known past diagnosis of estrogen receptor positive breast cancer or endometrial cancer
- Subjects with severe hypoxia at risk for acute intubation in ED
- History of stroke
- Any history of thromboembolic event including deep vein thrombosis or pulmonary emboli
- Current use of St. John's Wort
- Males on testosterone
- History of myocardial infarction, cardiac stents, or active angina
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook University Hospital
Stony Brook, New York, 11794
About this study
Official title: Phase II Clinical Trial of Estradiol to Reduce Severity of COVID19 Infection in COVID19+ and Presumptive COVID19+ Patients
The purpose of this study is to find out if estrogen, a female sex hormone, given as a patch placed on skin of COVID19 positive or presumptive positive patients for 7 days can reduce the severity of COVID19 symptoms compared to regular care.
This study has two study groups. One group will receive the study drug, a single-use Climara 25cm2 estrogen patch. The other group will receive standard of care.
Participants will be asked questions about their symptoms for up 6 times in up to 45 days.
Read the detailed description
As the COVID19 pandemic has spread, it has been observed that adult men of all ages and older women are at higher risk of developing serious complications from infection with the virus. Animal model studies of SARS suggest that the age and sex difference in COVID19 symptom severity may be due to protective and acute actions of the female sex hormone estrogen. Animal and human studies support immune modulating effects of estrogen that are acute acting in viral infections and wound repair processes that may reduce the damaging effects of the virus on the lung and symptom severity.
Our hypothesis is that a short 7 day course of estradiol delivered in a transdermal patch applied to the upper buttock in COVID19+ or presumptive positive patients will be safe and will reduce symptom severity in adult men and older women when given prior to intubation. COVID19+ and presumptive positive patients not requiring intubation will be enrolled to the study and randomized to receive an estrogen patch or standard of care. Patients will be followed up at day 1, 7, 14 and 28 for clinical symptoms and disease outcomes.
- Conditions
- COVID
- Being tested
- Estradiol patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol patchDrug
Participant receives estradiol 100 micrograms/day for 7 days through a patch applied on the skin
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Estradiol Patch Receives: Drug: Estradiol patch |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Hospitalization
Admission to hospital due to COVID-19 symptoms
Measured: 30 days
Rate of Transfer to Intensive Care Unit
Occurrence of admission to ICU due to COVID-19 symptoms
Measured: 30 days
Rate of Intubation
Occurrence of intubation
Measured: 30 days
Rate of Death
Occurrence of death from COVID-19
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start20 Apr 2020
- Primary completion30 Jul 2020
- Study completion30 Jul 2020
Why it stopped: Poor accrual
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 COVIDStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharon Nachman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sharon Nachman, Stony Brook University
- Investigators
- Sharon Nachman, MD, Principal investigator, Stony Brook University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359329
- Sponsor's protocol ID
- SBU-EstrogenPatch-COVID19
- Status last verified
- Apr 2020
- First submitted
- 21 Apr 2020
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sultana J, Crisafulli S, Gabbay F, Lynn E, Shakir S, Trifiro G. Challenges for Drug Repurposing in the COVID-19 Pandemic Era. Front Pharmacol. 2020 Nov 6;11:588654. doi: 10.3389/fphar.2020.588654. eCollection 2020.
PubMed 33240091
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial of Estradiol to Reduce Severity of COVID19 Infection in COVID19+ and Presumptive COVID19+ Patients
- ClinicalTrials.gov ID
- NCT04359329
- Acronym / sponsor ID
- SBU-EstrogenPatch-COVID19
- Conditions
- COVID
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Sharon NachmanUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 24 Apr 2020 (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 purpose of this study is to find out if estrogen, a female sex hormone, given as a patch placed on skin of COVID19 positive or presumptive positive patients for 7 days can reduce the severity of COVID19 symptoms compared to regular care.
This study has two study groups. One group will receive the study drug, a single-use Climara 25cm2 estrogen patch. The other group will receive standard of care.
Participants will be asked questions about their symptoms for up 6 times in up to 45 days.
Detailed description
As the COVID19 pandemic has spread, it has been observed that adult men of all ages and older women are at higher risk of developing serious complications from infection with the virus. Animal model studies of SARS suggest that the age and sex difference in COVID19 symptom severity may be due to protective and acute actions of the female sex hormone estrogen. Animal and human studies support immune modulating effects of estrogen that are acute acting in viral infections and wound repair processes that may reduce the damaging effects of the virus on the lung and symptom severity.
Our hypothesis is that a short 7 day course of estradiol delivered in a transdermal patch applied to the upper buttock in COVID19+ or presumptive positive patients will be safe and will reduce symptom severity in adult men and older women when given prior to intubation. COVID19+ and presumptive positive patients not requiring intubation will be enrolled to the study and randomized to receive an estrogen patch or standard of care. Patients will be followed up at day 1, 7, 14 and 28 for clinical symptoms and disease outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: Estradiol patchEstradiol Patch |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male ≥ 18 years of age or female ≥ 55 years of age
- Documentation of COVID19 positivity or the presence of one or more of the following new onset (<7 days) clinical features defining presumptive COVID19
- Able to provide informed consent
- Able to be contacted by telephone for follow-up
Key exclusion criteria (13 listed)
- Currently receiving estrogen based hormonal therapy
- Abnormal genital bleeding
- Protein C or Protein S deficiency
- Pre-existing liver impairment (e.g. Hepatitis C, cirrhosis)
- History of anaphylactic reaction or angioedema with Climara
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 |
|---|---|---|
| Estradiol patchParticipant receives estradiol 100 micrograms/day for 7 days through a patch applied on the skin | Drug | Active |
Primary outcome
Rate of Hospitalization
Time frame: 30 days
Admission to hospital due to COVID-19 symptoms
Rate of Transfer to Intensive Care Unit
Time frame: 30 days
Occurrence of admission to ICU due to COVID-19 symptoms
Rate of Intubation
Time frame: 30 days
Occurrence of intubation
Rate of Death
Time frame: 30 days
Occurrence of death from COVID-19
Results and safety
The study was stopped early (reason given: Poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
- Derived from this study: PubMed 33240091Sultana J, Crisafulli S, Gabbay F, Lynn E, Shakir S, Trifiro G. Challenges for Drug Repurposing in the COVID-19 Pandemic Era. Front Pharmacol. 2020 Nov 6;11:588654. doi: 10.3389/fphar.2020.588654. eCollection 2020.
- 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.
Sharon Nachman, MD principal investigator
Stony Brook University Hospital
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 Estradiol patch in people with COVID, run by Sharon Nachman at 1 site in United States.
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 8 inclusion and 13 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: stopped early, as of the sponsor's last update on 26 Nov 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 United States. 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?
The study was stopped early (reason given: Poor accrual). Results are not available in the source record.
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?
Rate of Hospitalization (time frame: 30 days). The study lists 4 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 NCT04359329, 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 26 Nov 2021.