Progesterone for the Treatment of COVID-19 in Hospitalized Men

Sara Ghandehari

Status and phase: Completed; Phase 1

Conditions: Sars-CoV2; COVID-19

Treatments: Drug: Progesterone 100 MG

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04365127

STUDY00000611

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Progesterone plus SOC

Experimental group

Description:

Progesterone 100 mg will be administered subcutaneously twice daily for 5 days in addition to institutional standard of care

Treatment:

Drug: Progesterone 100 MG

SOC only

No Intervention group

Description:

Subjects will receive institutional standard of care only