Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sara Ghandehari
With
IBSA Institut Biochimique SA
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.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Progesterone for the Treatment of COVID-19 in Hospitalized Men