Status:
COMPLETED
Progesterone for the Treatment of COVID-19 in Hospitalized Men
Lead Sponsor:
Sara Ghandehari
Collaborating Sponsors:
IBSA Institut Biochimique SA
Conditions:
COVID-19
Sars-CoV2
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess safety and efficacy of progesterone for treatment of COVID-19 in hospitalized men.
Detailed Description
Hospitalized men with COVID-19 who meet the eligibility criteria will be informed about study and the potential risks. All the patients giving written informed consent will be randomized in 1:1 ratio ...
Eligibility Criteria
Inclusion
- Laboratory-confirmed COVID-19 with in 72 hours prior to randomization
- Respiratory symptoms or abnormal lung exam or abnormal chest imaging AND oxygen saturation ≤94% on room air, or requiring supplemental oxygen less than 50% high flow
- Understands and agrees to comply with planned study procedures
- Agrees to the collection of venous blood per protocol
- Must agree to be placed on prophylactic dose of anticoagulation for prevention of deep venous thrombosis (DVT) while hospitalized
Exclusion
- ALT or AST \>5 times the upper limit of normal
- History of blood clots
- History of breast cancer
- Allergy to progesterone or betacyclodextrin
- Use of supplemental oxygen prior to hospital admission
- Requiring higher than 50% supplemental oxygen by high flow nasal cannula or mechanical ventilation
Key Trial Info
Start Date :
April 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04365127
Start Date
April 27 2020
End Date
August 20 2020
Last Update
January 27 2021
Active Locations (1)
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1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90035