Estrogen Patch for COVID-19 Symptoms

• ClinicalTrials.gov Identifier: NCT04359329
• Recruitment Status: Recruiting
• First Posted: April 24, 2020
• Last Update Posted: April 24, 2020
• Sponsor: Sharon Nachman
• Information provided by (Responsible Party): Sharon Nachman, Stony Brook University

Tracking Information

• First Submitted Date: April 21, 2020
• First Posted Date: April 24, 2020
• Last Update Posted Date: April 24, 2020
• Actual Study Start Date: April 20, 2020
• Estimated Primary Completion Date: November 15, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 22, 2020)

• 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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Estrogen Patch for COVID-19 Symptoms
• Official Title: Phase II Clinical Trial of Estradiol to Reduce Severity of COVID19 Infection in COVID19+ and Presumptive COVID19+ Patients

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 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: COVID

Intervention

Drug: Estradiol patch

Participant receives estradiol 100 micrograms/day for 7 days through a patch applied on the skin

Study Arms

• Experimental: Active
  Estradiol Patch
  Intervention: Drug: Estradiol patch
• No Intervention: Control
  No intervention

• Publications *: Sultana J, Crisafulli S, Gabbay F, Lynn E, Shakir S, Trifirò 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. Review.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 22, 2020): 110
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 15, 2020
• Estimated Primary Completion Date: November 15, 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Christina Preece; 631-371-3309; PatchStudy@stonybrookmedicine.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04359329
• Other Study ID Numbers: SBU-EstrogenPatch-COVID19
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Sharon Nachman, Stony Brook University
• Study Sponsor: Sharon Nachman
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sharon Nachman, MD; Stony Brook University Hospital

• PRS Account: Stony Brook University
• Verification Date: April 2020