COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04801836

NEURALIS s.a.

Not reported

2021-03-17

Unknown

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: postmenopausal women who have not used hormone replacement therapy (including oral, transdermal, topical, or vaginal preparations) within 1 year prior to study start. menopause is defined as women who have at least 12 months of spontaneous amenorrhea without another medical cause. or men ≥18 years of age who are willing to use adequate contraception from screening until 4 weeks after the last dose of study treatment. patients with sars-cov-2 infection confirmed by a nationally accepted rt-pcr assay and moderate covid-19. patients with a strong clinical suspicion of moderate covid-19 and a positive point-of-care test for viral infection can also be entered while the result of a nationally accepted rt-pcr assay is awaited; if the rt-pcr assay result is negative, the treatment must be stopped and the patient must be discontinued from the study. to meet the definition of moderate covid-19, it is sufficient for a patient to have been hospitalized due to covid-19 illness. hospitalized. clinical frailty score ≤5. the clinical frailty scale is a nine-point global frailty scale (ranging from 1: "very fit" to 9: "terminally ill") based on clinical evaluation in the domains of mobility, energy, physical activity, and function. people scoring at 5: "mildly frail" often have more evident slowing and need help in high order instrumental activities of daily living (iadls) (finances, transportation, heavy housework, medications). typically, mild frailty progressively impairs shopping and walking outside alone, meal preparation and housework. who ordinal scale for clinical improvement score of 4 or 5. able to provide informed consent. able to comply with the study procedures as defined in this protocol.

males currently receiving estrogen-based hormonal therapy. current participation in another interventional clinical trial. ventilated and/or in icu. any unexplained abnormal bleeding including, but not limited to, vaginal bleeding. diagnosed protein c, protein s or antithrombin iii deficiency or any other known inherited or acquired thrombophilic abnormalities (e.g. hyperhomocysteinemia, anti-phospholipid antibodies). renal impairment (glomerular filtration rate [gfr] <30 ml/min/1.73 m²). presence or history of severe liver disease or liver cancer (non-malignant or malignant). presence or history (including suspected diagnosis) of breast cancer. presence or history (including suspected diagnosis) of estrogen-sensitive tumors (e.g. endometrial cancer). patients with endometrial hyperplasia. patients with severe hypoxemia at risk of endotracheal intubation. immunocompromised patients history of stroke, acute coronary syndromes, or angina pectoris. presence or history of arterial or venous thrombosis/thrombembolia (including deep vein thrombosis and pulmonary emboli). patients with any condition, including findings in the patients' medical history or in the screening study assessments that in the opinion of the investigator, constitute a risk or a contraindication for the participation of the patient into the study or that could interfere with the study objectives, conduct or evaluation, including patients with suspected genital cancer or suspected breast cancer and patients with increased risk of development of venous thrombosis/thromboembolia for reasons other than covid-19 disease. use of zanamivir or oseltamivir within 1 week prior to randomization. patients who have received prior investigational or off-label agents for covid-19. (note: use of antivirals and corticosteroids is allowed if part of standard of care). using methyldopa or clonidine containing antihypertensive medication. hypersensitivity to the active substance of the study drug or any other components of the study drug.

2

NEURALIS s.a.

18

100

Belgium;Hungary;Poland;Russia

Moderate disease at enrollment

3: Moderate disease at enrollment

162

Percentage of participants who have recovered at Day 28

None

Phase 2

[{"arm_notes": "", "treatment_id": 481, "treatment_name": "Estetrol", "treatment_type": "Hormones", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]