Estradiol and Progesterone in Hospitalized COVID-19 Patients

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Covid19

In brief

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.

Key facts

Study ID

NCT04865029

Run by

Tulane University

People needed

10

Starts

2021-07-22

Expected to finish

2022-01-25

Last updated by the study team

2023-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Patients taking St. John's Wort preparations (Hypericum perforatum), phenobarbital, carbamazepine, and rifampin.
• Patients within 6 weeks of major orthopedic surgery.

Where it is running

• Tulane University Medical Center — New Orleans, Louisiana, United States

Full record on ClinicalTrials.gov

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