Estrogen Patch for COVID-19 Symptoms

NCT04359329 | Terminated Phase 2 FDA Drug

• 1 other identifier: SBU-EstrogenPatch-COVID19
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Active

EXPERIMENTAL

Estradiol Patch

Drug: Estradiol patch

Control

NO INTERVENTION

No intervention

Interventions

Estradiol patch DRUG

Participant receives estradiol 100 micrograms/day for 7 days through a patch applied on the skin

Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sharon Nachman: lead

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Related Publications (1)

• 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.

  PMID: 33240091 DERIVED

MeSH Terms

Interventions

Ortho Evra

Study Officials

• Sharon Nachman, MD

  Stony Brook University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Pediatric Infectious Diseases

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 24, 2020
• Study Start: April 20, 2020
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2020
• Last Updated: November 26, 2021

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)