The purpose of this study is to assess safety and efficacy of progesterone for treatment of COVID-19 in hospitalized men.
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 to progesterone (100 mg SQ twice daily) plus standard of care or standard of
care alone.
Drug: Progesterone 100 MG
Subcutaneous administration twice daily
Inclusion Criteria:
1. Laboratory-confirmed COVID-19 with in 72 hours prior to randomization
2. 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
3. Understands and agrees to comply with planned study procedures
4. Agrees to the collection of venous blood per protocol
5. Must agree to be placed on prophylactic dose of anticoagulation for prevention of deep
venous thrombosis (DVT) while hospitalized
Exclusion Criteria:
1. ALT or AST >5 times the upper limit of normal
2. History of blood clots
3. History of breast cancer
4. Allergy to progesterone or betacyclodextrin
5. Use of supplemental oxygen prior to hospital admission
6. Requiring higher than 50% supplemental oxygen by high flow nasal cannula or mechanical
ventilation
Cedars Sinai Medical Center
Los Angeles, California, United States
Sara Ghandehari, MD, Principal Investigator
Cedars-Sinai Medical Center