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
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|
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 (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Drug: Estradiol patch
Participant receives estradiol 100 micrograms/day for 7 days through a patch applied on the skin
No Intervention: Control
- 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
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
|Contact: Christina Preece||631-371-3309||PatchStudy@stonybrookmedicine.edu|
|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|
|Principal Investigator:||Sharon Nachman, MD||Stony Brook University Hospital|