COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04865029

Franck Mauvais-Jarvias

Not reported

2021-04-29

Terminated

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: 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.

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.

2

Tulane University

18

100

United States

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

10

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

None

Phase 2

[{"arm_notes": "", "treatment_id": 1500, "treatment_name": "Estradiol+progesterone", "treatment_type": "Hormones", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]