Estrogen Patch for COVID-19 Symptoms

Phase II Clinical Trial of Estradiol to Reduce Severity of COVID19 Infection in COVID19+ and Presumptive COVID19+ Patients

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.

Study Overview

• Status: Terminated
• Conditions: COVID
• Intervention / Treatment: Drug: Estradiol patch

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: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; No intervention
EXPERIMENTAL: Active; Estradiol Patch	Drug: Estradiol patch; Participant receives estradiol 100 micrograms/day for 7 days through a patch applied on the skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Hospitalization	Admission to hospital due to COVID-19 symptoms	30 days
Rate of Transfer to Intensive Care Unit	Occurrence of admission to ICU due to COVID-19 symptoms	30 days
Rate of Intubation	Occurrence of intubation	30 days
Rate of Death	Occurrence of death from COVID-19	30 days

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 20, 2020
• Primary Completion (ACTUAL): July 30, 2020
• Study Completion (ACTUAL): July 30, 2020

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: April 22, 2020
• First Posted (ACTUAL): April 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 26, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Estradiol
• Other Study ID Numbers: SBU-EstrogenPatch-COVID19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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