COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04456049

Ricardo Pereira Mestre

Not reported

2020-07-02

Terminated

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: - documented covid-19 infection (confirmed by nps positive pcr for sars-cov-2) with mild symptoms not requiring hospitalization - first nps ≤4 days (96 hours) since onset of symptoms - randomization ≤72 hours since first nps - adult males aged ≥ 50 years - indication for outpatient treatment but at high risk for complications, at least 1 risk factor (age ≥ 65 years, hypertension, diabetes, cardiovascular disease, active malignancy, copd) - who performance status 0-1 - adequate hematologic values: haemoglobin ≥ 100 g/l, neutrophils ≥ 1.0 x 10(9)/l, platelets ≥ 150 x 10(9)/l. - adequate hepatic function: alt and ast ≤ 2.5 x uln, bilirubin ≤ 1.5 x uln (exception if gilbert's syndrome ≤ 2.5 x uln) - adequate renal function: calculated creatinine clearance ≥ 50 ml/min according to the formula of cockcroft-gault - patient is able to swallow the trial drugs and to comply with trial requirements - patient agrees not to father a child during participation in the trial and for 3 months thereafter

- female sex - moderate to severe covid-19 symptoms requiring hospitalization - patients requiring inpatient treatment - concurrent antiviral drugs or ongoing interventional clinical trial or any off label drug for covid-19 - patients with ongoing prostate cancer treatment - clinically significant cardiovascular disease including: - myocardial infarction within 6 months prior to registration, - uncontrolled angina within 3 months prior to registration, - congestive heart failure nyha class iii or vi - qtc interval > 480 ms - history of clinically significant ventricular arrhythmias (e.g. ventricular tachycardia, ventricular fibrillation, torsades de pointes) - history of mobitz ii second or third degree heart block without a permanent pacemaker in place - uncontrolled hypertension as indicated by systolic blood pressure > 170 mmhg or diastolic blood pressure > 105 mmhg - deep venous thrombosis or pulmonary embolism within 6 months - history of cerebrovascular disease - severe concurrent disease, infection or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrolment. - known history of hiv, hepatitis b, hepatitis c - known history of seizures or any conditions that may predispose to seizure. history of loss of consciousness or ischemic cerebrovascular attack within 12 months prior to registration - concurrent anticoagulation with rivaroxaban or warfarin. concomitant and continuous use of systemic corticosteroids exceeding 10 mg/day of prednisone or a dose equivalent corticosteroid within 14 days before registration. - known hypersensitivity to enzalutamide or hypersensitivity to any of its components - any concomitant drugs contraindicated for use with enzalutamide according to the swissmedic approved product information - any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol and follow-up.

2

Ricardo Pereira Mestre

50

100

Switzerland

Mild disease at enrollment

1: Mild disease at enrollment

7

Efficacy of Enzalutamide by decreasing SARS-CoV-2 viral expression

None

Phase 2

[{"arm_notes": "", "treatment_id": 468, "treatment_name": "Enzalutamide", "treatment_type": "Hormones", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]