Covid19 Clinical Trial
Official title:
Acute Estradiol and Progesterone Therapy in Hospitalized Adults to Reduce Coronavirus Disease (COVID-19) Severity: A Randomized Control Trial
Verified date | June 2023 |
Source | Tulane University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 10 |
Est. completion date | January 25, 2022 |
Est. primary completion date | January 25, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Tulane University Medical Center | New Orleans | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Tulane University |
United States,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | The proportion will be calculated based on WHO ordinal scale for clinical improvement. The scale is from 0 to 8, with a higher score indicating worse clinical status. Uninfected: No clinical or virological evidence of infection 0 Ambulatory: No limitation of activities 1 Limitation of activities 2 Hospitalized Mild Disease Hospitalized, no oxygen therapy 3 Oxygen by mask or nasal prongs 4 Hospitalized Severe Disease Non-invasive ventilation or high flow oxygen 5 Intubation and mechanical ventilation 6 Ventilation + additional organ support - 7 pressors, Renal Replacement Therapy (RRT), Extracorporeal Membrane Oxygenation (ECMO) Dead Death 8 |
At discharge, measured up to Day 21 | |
Secondary | Length of Hospital Stay | The investigators will review patients' medical records on day 14 and day 28. Then, the investigators will call patients on day 60. This will be done to determine the efficiency of treatment on length of hospital stay. | Baseline to day 60 | |
Secondary | Readmission | The investigators will review patients' medical records on day 14 and day 28. Then, the investigators will call patients on day 60. This will be done to determine the readmission rates. | Baseline to day 60 | |
Secondary | Number of Patients Requiring Invasive Mechanical Ventilation | The investigators will review patients' medical records on day 14 and day 28. Then, the investigators will call patients on day 60. This will be done to determine the number of patients requiring invasive mechanical ventilation | Baseline to day 60 | |
Secondary | Number of Days Death Occurred After Admission | The investigators will review patients' medical records on day 14 and day 28 and calculate number of deaths that occurred after admission. Then, the investigators will call patients on day 60. This will be done to determine the number of days death occurred after admission. | Baseline to day 60 | |
Secondary | Number of Participants With Each Cause of Death | The investigators will review patients' medical records on day 14 and day 28 and determine the cause of death. Then, the investigators will call patients on day 60. This will be done to determine the cause of death. | Baseline to day 60 | |
Secondary | Grade 3 Adverse Events Occurrence | Subjects will be followed daily for 7 days after initiation of treatment for adverse events. The investigators will review patients' medical records on day 14 and day 28. Then, the investigators will call patients on day 60. This will be done to determine the frequency and severity of adverse events in treatment arm vs. control arm. | Baseline to day 60 | |
Secondary | Serious Adverse Events Occurrence | Subjects will be followed daily for 7 days after initiation of treatment for serious adverse events. The investigators will review patients' medical records on day 14 and day 28. Then, the investigators will call patients on day 60. This will be done to determine the frequency of serious adverse events in treatment arm vs. control arm. | Baseline to day 60 |
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