Clinical trial

Acute Estradiol and Progesterone Therapy in Hospitalized Adults to Reduce Coronavirus Disease (COVID-19) Severity: A Randomized Control Trial

Name

2020-939

Description

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.

Trial arms

Trial start

2021-07-22

Estimated PCD

2022-01-25

Trial end

2022-01-25

Status

Terminated

Phase

Early phase I

Treatment

Placebo injection and placebo pill

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

Arms:

Control Arm

Estradiol Cypionate 5 mg/ml

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

Arms:

Treatment Arm

Progesterone 200 mg Oral Capsule

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

Arms:

Treatment Arm

Size

Primary endpoint

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

At discharge, measured up to Day 21

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, placebo-controlled', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Double-blinded clinical trial', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 10, 'type': 'ACTUAL'}}

Updated at

2023-06-27

1 organization

2 products

1 indication

Organization

Product

Indication

Product