Status:
TERMINATED
Estrogen Patch for COVID-19 Symptoms
Lead Sponsor:
Sharon Nachman
Conditions:
COVID
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 C...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2020
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04359329
Start Date
April 20 2020
End Date
July 30 2020
Last Update
November 26 2021
Active Locations (1)
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1
Stony Brook University Hospital
Stony Brook, New York, United States, 11794