Estrogen Patch for COVID-19 Symptoms

• ClinicalTrials.gov Identifier: NCT04359329
• Recruitment Status: Terminated
• First Posted: April 24, 2020
• Last Update Posted: November 26, 2021
• Sponsor: Sharon Nachman
• Information provided by (Responsible Party): Sharon Nachman, Stony Brook University

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.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2 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
• Actual Primary Completion Date: July 30, 2020
• Actual Study Completion Date: July 30, 2020

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, New York

Stony Brook University Hospital

Stony Brook, New York, United States, 11794

Sponsors and Collaborators

Sharon Nachman

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• Last Update Posted: November 26, 2021
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Estradiol; Estrogens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs