Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
2 participants
INTERVENTIONAL
2020-04-20
2020-07-30
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Active
Estradiol Patch
Estradiol patch
Participant receives estradiol 100 micrograms/day for 7 days through a patch applied on the skin
Control
No intervention
No interventions assigned to this group
Interventions
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Estradiol patch
Participant receives estradiol 100 micrograms/day for 7 days through a patch applied on the skin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Sharon Nachman
OTHER
Responsible Party
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Sharon Nachman
Director of Pediatric Infectious Diseases
Principal Investigators
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Sharon Nachman, MD
Role: PRINCIPAL_INVESTIGATOR
Stony Brook University Hospital
Locations
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Stony Brook University Hospital
Stony Brook, New York, United States
Countries
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References
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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.
Other Identifiers
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SBU-EstrogenPatch-COVID19
Identifier Type: -
Identifier Source: org_study_id