Estradiol and Progesterone in Hospitalized COVID-19 Patients

NCT04865029 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 2020-939
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Estradiol; Progesterone; Covid19; Estrogen; Hormones; Progestogens; Depo-Estradiol; Prometrium; Micronized Progesterone

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Scores 1 or 2 on the 9-point World Health Organization (WHO) Ordinal Scale at Discharge, Measured up to Day 21

  The proportion will be calculated based on WHO ordinal scale for clinical improvement. The scale is from 0 to 8, with a higher score indicating worse clinical status. * Uninfected: No clinical or virological evidence of infection 0 * Ambulatory: No limitation of activities 1 Limitation of activities 2 * Hospitalized Mild Disease Hospitalized, no oxygen therapy 3 Oxygen by mask or nasal prongs 4 * Hospitalized Severe Disease Non-invasive ventilation or high flow oxygen 5 Intubation and mechanical ventilation 6 Ventilation + additional organ support - 7 pressors, Renal Replacement Therapy (RRT), Extracorporeal Membrane Oxygenation (ECMO) * Dead Death 8

  At discharge, measured up to Day 21

Secondary Outcomes (7)

• Length of Hospital Stay

  Baseline to day 60

• Readmission

  Baseline to day 60

• Number of Patients Requiring Invasive Mechanical Ventilation

  Baseline to day 60

• Number of Days Death Occurred After Admission

  Baseline to day 60

• Number of Participants With Each Cause of Death

  Baseline to day 60

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission and Progesterone 200mg by mouth daily for 5 days starting at admission.

Drug: Estradiol Cypionate 5 mg/ml; Drug: Progesterone 200 mg Oral Capsule

Control Arm

OTHER

Standard of Care along with placebo injection and placebo pill Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines

Other: Placebo injection and placebo pill

Interventions

Placebo injection and placebo pill OTHER

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

Control Arm

Estradiol Cypionate 5 mg/ml DRUG

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

Treatment Arm

Progesterone 200 mg Oral Capsule DRUG

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

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalization at Tulane Medical Center in the Department of General Internal Medicine and Geriatrics with COVID-19 (WHO Ordinal scale score 3-5) and confirmed by SARS-CoV-2 Polymerase Chain Reaction (PCR).
• Respiratory symptoms (fever, shortness of breath or cough) or abnormal lung exam or chest imaging characteristic of mild to severe COVID-19 pneumonia.
• Patient and/or legally authorized representative (LAR) agrees to comply with study procedures and the collection of blood samples per protocol.
• Patient and/or LAR agrees to be placed on prophylactic dose of anticoagulation for prevention of deep venous thrombosis (DVT) (if necessary).
• Patient or legally authorized representative has signed informed consent.
• Women of childbearing age with a negative pregnancy test on admission.

You may not qualify if:

• Patient under 18 years of age.
• Critical COVID-19 (respiratory failure requiring intubation and mechanical ventilation, shock, multi-organ failure).
• Pregnant women confirmed by pregnancy test.
• Women who are within six weeks of postpartum.
• Patient is not hospitalized at Tulane Medical Center with confirmed COVID-19.
• Patient included in another COVID-19 trial (excluding hydroxychloroquine and dexamethasone).
• Women already treated by estrogen and or progestogen therapy two weeks prior to admission.
• Men already treated by testosterone therapy prior to admission.
• History of breast or endometrial cancer.
• Abnormal genital bleeding.
• Active or recent (e.g., within the past year) stroke or myocardial infarction.
• History of blood clots including deep vein thrombosis related to clotting disease, or pulmonary emboli (prior to hospitalization).
• History of liver dysfunction or disease.
• Patients with end-stage renal disease
• Patients taking inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, and ritonavir.

Sponsors & Collaborators

• Tulane University: lead

Study Sites (1)

Tulane University Medical Center

New Orleans, Louisiana, 70112, United States

Location

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MeSH Terms

Conditions

COVID-19

Interventions

estradiol 17 beta-cypionate; Progesterone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Franck Mauvais-Jarvis
• Organization: Tulane University

fmauvais@tulane.edu

504-259-1139

Study Officials

• Franck Mauvais-Jarvias, MD, PhD

  Tulane University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded clinical trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, placebo-controlled

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 29, 2021
• Study Start: July 22, 2021
• Primary Completion: January 25, 2022
• Study Completion: January 25, 2022
• Last Updated: June 27, 2023
• Results First Posted: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)