Official Title
A Single Center, Randomized, Controlled Trial of the Safety and Efficacy of Progesterone for the Treatment of COVID-19 in Hospitalized Men
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 to progesterone (100 mg SQ twice daily) plus standard of care or standard of
care alone.

Completed
COVID-19
SARS-COV2

Drug: Progesterone 100 MG

Subcutaneous administration twice daily

Eligibility 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

Eligibility Gender
Male
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Cedars Sinai Medical Center
Los Angeles, California, United States

Sara Ghandehari, MD, Principal Investigator
Cedars-Sinai Medical Center

IBSA Institut Biochimique SA
NCT Number
MeSH Terms
COVID-19
Progesterone