Estrogen Patch for COVID-19 Symptoms

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Clinical Trial of Estradiol to Reduce Severity of COVID19 Infection in COVID19+ and Presumptive COVID19+ Patients

Conditions
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COVID

Intervention / Treatment
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* Drug: Estradiol patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Estradiol Patch | Drug: Estradiol patch<br>* Participant receives estradiol 100 micrograms/day for 7 days through a patch applied on the skin<br>|
| No Intervention: Control<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Hospitalization | Admission to hospital due to COVID-19 symptoms | 30 days | 
| Rate of Transfer to Intensive Care Unit | Occurrence of admission to ICU due to COVID-19 symptoms | 30 days | 
| Rate of Intubation | Occurrence of intubation | 30 days | 
| Rate of Death | Occurrence of death from COVID-19 | 30 days |