Estradiol and Progesterone in Hospitalized COVID-19 Patients
Condition: Covid19
MeSH terms: COVID-19
Intervention: Placebo injection and placebo pill; Estradiol Cypionate 5 mg/ml; Progesterone 200 mg Oral Capsule
Intervention description: Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines; Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission.; Standard of Care along with Progesterone 200mg by mouth daily for 5 days starting at admission.
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate; Progesterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blinded clinical trial
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Estradiol; Progesterone; Covid19; Estrogen; Hormones; Progestogens; Depo-Estradiol; Prometrium; Micronized Progesterone

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.
    

Eligibility 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.