Progesterone for the Treatment of COVID-19 in Hospitalized Men
Purpose
The purpose of this study is to assess safety and efficacy of progesterone for treatment of COVID-19 in hospitalized men.
Conditions
- COVID-19
- Sars-CoV2
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Progesterone plus SOC |
Progesterone 100 mg will be administered subcutaneously twice daily for 5 days in addition to institutional standard of care |
|
|
No Intervention SOC only |
Subjects will receive institutional standard of care only |
|
Recruiting Locations
More Details
- NCT ID
- NCT04365127
- Status
- Completed
- Sponsor
- Sara Ghandehari
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 to progesterone (100 mg SQ twice daily) plus standard of care or standard of care alone.