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Estrogen Patch for COVID-19 Symptoms

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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

Tracking Information
First Submitted Date  ICMJE April 21, 2020
First Posted Date  ICMJE April 24, 2020
Last Update Posted Date April 24, 2020
Actual Study Start Date  ICMJE April 20, 2020
Estimated Primary Completion Date November 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Estrogen Patch for COVID-19 Symptoms
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID
Intervention  ICMJE Drug: Estradiol patch
Participant receives estradiol 100 micrograms/day for 7 days through a patch applied on the skin
Study Arms  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 22, 2020)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 15, 2020
Estimated Primary Completion Date November 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christina Preece 631-371-3309 PatchStudy@stonybrookmedicine.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04359329
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Sharon Nachman, Stony Brook University
Study Sponsor  ICMJE Sharon Nachman
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sharon Nachman, MD Stony Brook University Hospital
PRS Account Stony Brook University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP