Status:
TERMINATED
Estradiol and Progesterone in Hospitalized COVID-19 Patients
Lead Sponsor:
Tulane University
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 o...
Detailed Description
Severe Acute Respiratory Syndrome Associated Corona Virus (SARS-CoV-2), causing COVID-19, has killed over 2.8 million people globally, including 550,000 in the US as of March 2021. Although, the vacci...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04865029
Start Date
July 22 2021
End Date
January 25 2022
Last Update
June 27 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tulane University Medical Center
New Orleans, Louisiana, United States, 70112