Progesterone for the Treatment of COVID-19 in Hospitalized Men

• Status: Completed
• Trial end date: 2020-08-20
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to assess safety and efficacy of progesterone for treatment of COVID-19 in hospitalized men.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sara Ghandehari
• Collaborator: IBSA Institut Biochimique SA
• Treatments: Progesterone

Criteria

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