COVID-19, Sars-CoV2
Conditions
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.
Interventions
DRUGProgesterone 100 MG
Subcutaneous administration twice daily
Sponsors
IBSA Institut Biochimique SA
Sara Ghandehari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed