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Trial record 1 of 4 for:    estrogen | Covid-19
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Estrogen Patch for COVID-19 Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04359329
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Sharon Nachman, Stony Brook University

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.


Condition or disease Intervention/treatment Phase
COVID Drug: Estradiol patch Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial of Estradiol to Reduce Severity of COVID19 Infection in COVID19+ and Presumptive COVID19+ Patients
Actual Study Start Date : April 20, 2020
Estimated Primary Completion Date : November 15, 2020
Estimated Study Completion Date : November 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active
Estradiol Patch
Drug: Estradiol patch
Participant receives estradiol 100 micrograms/day for 7 days through a patch applied on the skin

No Intervention: Control
No intervention



Primary Outcome Measures :
  1. Rate of Hospitalization [ Time Frame: 30 days ]
    Admission to hospital due to COVID-19 symptoms

  2. Rate of Transfer to Intensive Care Unit [ Time Frame: 30 days ]
    Occurrence of admission to ICU due to COVID-19 symptoms

  3. Rate of Intubation [ Time Frame: 30 days ]
    Occurrence of intubation

  4. Rate of Death [ Time Frame: 30 days ]
    Occurrence of death from COVID-19



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04359329


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

Locations
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United States, New York
Stony Brook University Hospital Recruiting
Stony Brook, New York, United States, 11794
Contact: Christina Preece, MD    631-371-3309    PatchStudy@stonybrookmedicine.edu   
Contact: Patricia Thompson         
Principal Investigator: Sharon Nachman, MD         
Sub-Investigator: Alison Stopeck, MD         
Sub-Investigator: Patricia Thompson, PhD         
Sub-Investigator: Antonio Gasparis, MD         
Sub-Investigator: Andrew Handel, MD         
Sub-Investigator: Jie Yang, PhD         
Sponsors and Collaborators
Sharon Nachman
Investigators
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Principal Investigator: Sharon Nachman, MD Stony Brook University Hospital
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Responsible Party: Sharon Nachman, Director of Pediatric Infectious Diseases, Stony Brook University
ClinicalTrials.gov Identifier: NCT04359329    
Other Study ID Numbers: SBU-EstrogenPatch-COVID19
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs