Progesterone for the Treatment of COVID-19 in Hospitalized Men

Completed · Phase 1

Conditions studied: COVID-19, Sars-CoV2

In brief

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

Key facts

Study ID

NCT04365127

Run by

Sara Ghandehari

People needed

40

Starts

2020-04-27

Expected to finish

2020-08-20

Last updated by the study team

2021-01-27

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Laboratory-confirmed COVID-19 with in 72 hours prior to randomization
• 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
• Understands and agrees to comply with planned study procedures
• Agrees to the collection of venous blood per protocol
• Must agree to be placed on prophylactic dose of anticoagulation for prevention of deep venous thrombosis (DVT) while hospitalized

You may not qualify if…

• ALT or AST >5 times the upper limit of normal
• History of blood clots
• History of breast cancer
• Allergy to progesterone or betacyclodextrin
• Use of supplemental oxygen prior to hospital admission
• Requiring higher than 50% supplemental oxygen by high flow nasal cannula or mechanical ventilation

Where it is running

• Cedars Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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