PROTECT: A randomized study with Hydroxychloroquine versus observational support for prevention or early phase treatment of Coronavirus disease (COVID-19). - PROTECT

ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS0 个研究点目标入组 2,300 人开始时间: 2020年6月24日最近更新: 2022年3月14日

适应症

试验速览

暂无简介。

•1) Male or Female, aged >= 18 years
•2) SARS-CoV-2-exposed subjects, as household members and/or contacts of COVID-19 patients (GROUP 1). In this group are included Health care professionals in contact with COVID-19 patients. or
•3) COVID-19 patients, asymptomatic or paucisymptomatic in home situation who are not in treatment with any anti COVID-19 medication (GROUP 2)
•4) Absence of any COVID-19 symptom in last week before randomization (fever >37.5°C, cough, dyspnea) (only for GROUP 1 subjects)
•5) Paracetamol treatment is accepted only for GROUP 2.
•6) Participant is willing and able to give informed consent for participation in the study (either recorded during a telephonic interview or signed in person) and agrees with the study and its conduct.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1800
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 500

•1) Reported anamnesis for:
•a. Intolerance or previous toxicity for hydroxychloroquine/chloroquine
•b. Bradycardia or reduction rhythm of heart with arrythmias
•c. Ischemic heart disease
•d. Retinopathy
•e. Congestive heart failure under/with use of diuretics
•f. Favism or glucose-6-phosphate dehydrogenase (G6PD) deficiency
•g. Diabetes type 1
•h. Major comorbidities like advanced chronic kidney disease or dialysis therapy, known history of ventricular arrhythmias, any oncologic/hematologic malignancy.
•i. Severe neurological and mental illness
•2) Any other contraindication to take hydroxychloroquine
•3) Already taking chloroquine, hydroxychloroquine or analogous during the past 3 weeks
•4) Use of other antiviral agents in the last 3 weeks
•5) Known positiveness for HIV, active HCV, HBV infection
•6) Subject with a positive test for SARS-CoV-2 (for Group 1)
•7) Pregnant or lactating
•8) Current use of medications with known significant drug-drug interactions: digoxin, hypoglycemic agents, anticonvulsant, Cyclosporine, Phenylbutazone, drugs that inhibit CYP2D6
•9) Known prolonged QT syndrome or current use of drugs with known QT prolungation
•10) Participation in another clinical trial with any investigational agents within 30 days prior to study screening.

发起方

ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS