Estradiol and Progesterone in Hospitalized COVID-19 Patients

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tulane University
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Polyestradiol phosphate; Progesterone

Criteria

Inclusion Criteria:

1. 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).

2. Respiratory symptoms (fever, shortness of breath or cough) or abnormal lung exam or chest imaging characteristic of mild to severe COVID-19 pneumonia.

3. Patient and/or legally authorized representative (LAR) agrees to comply with study procedures and the collection of blood samples per protocol.

4. Patient and/or LAR agrees to be placed on prophylactic dose of anticoagulation for prevention of deep venous thrombosis (DVT) (if necessary).

5. Patient or legally authorized representative has signed informed consent.

6. Women of childbearing age with a negative pregnancy test on admission.

Exclusion Criteria:

1. Patient under 18 years of age.

2. Critical COVID-19 (respiratory failure requiring intubation and mechanical ventilation, shock, multi-organ failure).

3. Pregnant women confirmed by pregnancy test.

4. Women who are within six weeks of postpartum.

5. Patient is not hospitalized at Tulane Medical Center with confirmed COVID-19.

6. Patient included in another COVID-19 trial (excluding hydroxychloroquine and dexamethasone).

7. Women already treated by estrogen and or progestogen therapy two weeks prior to admission.

8. Men already treated by testosterone therapy prior to admission.

9. History of breast or endometrial cancer.

10. Abnormal genital bleeding.

11. Active or recent (e.g., within the past year) stroke or myocardial infarction.

12. History of blood clots including deep vein thrombosis related to clotting disease, or pulmonary emboli (prior to hospitalization).

13. History of liver dysfunction or disease.

14. Patients with end-stage renal disease

15. Patients taking inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, and ritonavir.

16. Patients taking St. John's Wort preparations (Hypericum perforatum), phenobarbital, carbamazepine, and rifampin.

17. Patients within 6 weeks of major orthopedic surgery.