Progesterone for the Treatment of COVID-19 in Hospitalized Men

Phase 1

Completed

• Conditions: COVID-19; Sars-CoV2
• Interventions: Drug: Progesterone 100 MG

• Registration Number: NCT04365127
• Lead Sponsor: Sara Ghandehari

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.

Study Timeline

• Study First Submitted: 2020-04-24
• Study First Submitted QC: 2020-04-24
• Study Start: 2020-04-27
• Study First Posted: 2020-04-28
• Primary Completion: 2020-08-20
• Study Completion: 2020-08-20
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Progesterone plus SOC	Progesterone 100 MG	Progesterone 100 mg will be administered subcutaneously twice daily for 5 days in addition to institutional standard of care

Primary Outcome Measures

Name	Time	Method
Change in clinical status of subjects at Day 7 based on the following 7-point ordinal scale	7 days	Change in clinical status of subjects at Day 7 based on the following 7-point ordinal scale; 1. Death; 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, on high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen; 6. Not hospitalized, limitation on activities; 7. Not hospitalized, no limitations on activities

Secondary Outcome Measures

Name	Time	Method
Change in clinical status of subjects assessed daily while hospitalized and on Day 15	29 days	Change in clinical status of subjects daily while hospitalized and at Day 15 based on the following 7-point ordinal scale; 1. Death; 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, on high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen; 6. Not hospitalized, limitation on activities; 7. Not hospitalized, no limitations on activities
Duration of supplemental oxygen, mechanical ventilation (if applicable), and hospitalization	15 days	The length of time that the subjects require supplemental oxygen.; The length of time that the subjects require mechanical ventilation (if applicable).; The length of time that the subjects remain in the hospital.

Trial Locations

Locations (1)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States