Progesterone for the Treatment of COVID-19 in Hospitalized Men

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-27

Study Completion Date

2020-08-20

Brief Summary

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

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Detailed Description

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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.

Conditions

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COVID-19 Sars-CoV2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Progesterone plus SOC

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

Group Type EXPERIMENTAL

Progesterone 100 MG

Intervention Type DRUG

Subcutaneous administration twice daily

SOC only

Subjects will receive institutional standard of care only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Progesterone 100 MG

Subcutaneous administration twice daily

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No