Estrogen Patch for COVID-19 Symptoms
Primary Purpose
COVID
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Estradiol patch
Sponsored by
About this trial
This is an interventional treatment trial for COVID
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
- 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 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
Sites / Locations
- Stony Brook University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Active
Control
Arm Description
Estradiol Patch
No intervention
Outcomes
Primary Outcome Measures
Rate of Hospitalization
Admission to hospital due to COVID-19 symptoms
Rate of Transfer to Intensive Care Unit
Occurrence of admission to ICU due to COVID-19 symptoms
Rate of Intubation
Occurrence of intubation
Rate of Death
Occurrence of death from COVID-19
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04359329
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
Poor accrual
Study Start Date
April 20, 2020 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
July 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sharon Nachman
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
Estradiol Patch
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
Estradiol patch
Intervention Description
Participant receives estradiol 100 micrograms/day for 7 days through a patch applied on the skin
Primary Outcome Measure Information:
Title
Rate of Hospitalization
Description
Admission to hospital due to COVID-19 symptoms
Time Frame
30 days
Title
Rate of Transfer to Intensive Care Unit
Description
Occurrence of admission to ICU due to COVID-19 symptoms
Time Frame
30 days
Title
Rate of Intubation
Description
Occurrence of intubation
Time Frame
30 days
Title
Rate of Death
Description
Occurrence of death from COVID-19
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Nachman, MD
Organizational Affiliation
Stony Brook University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33240091
Citation
Sultana J, Crisafulli S, Gabbay F, Lynn E, Shakir S, Trifiro 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.
Results Reference
derived
Learn more about this trial
Estrogen Patch for COVID-19 Symptoms
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