Estrogen Patch for COVID-19 Symptoms

• Status: Recruiting
• Trial end date: 2020-11-15
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sharon Nachman
• Treatments: Estradiol

Criteria

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

1. fever of >100.5°F or 38°C

2. shortness of breath

3. cough

4. 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