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Estradiol and Progesterone in Hospitalized COVID-19 Patients

NCT04865029 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-06-27

Study results available
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Summary

The purpose of this study is to determine to what extent a short systemic steroid therapy with estradiol and progesterone, administered early to hospitalized and confirmed COVID-19 positive patients of both sexes in addition to standard of care (SOC) can reduce the severity of symptoms and outcomes compared to SOC alone.

Conditions

  • Covid19

Interventions

OTHER

Placebo injection and placebo pill

Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines

DRUG

Estradiol Cypionate 5 mg/ml

Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission.

DRUG

Progesterone 200 mg Oral Capsule

Standard of Care along with Progesterone 200mg by mouth daily for 5 days starting at admission.

Sponsors & Collaborators

  • Tulane University

    lead OTHER

Principal Investigators

  • Franck Mauvais-Jarvias, MD, PhD · Tulane University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-22
Primary Completion
2022-01-25
Completion
2022-01-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04865029 on ClinicalTrials.gov