PROTECT: studio randomizzato con idrossiclorochina vs osservazione per la prevenzione e il trattamento precoce della malattia da coronavirus (COVID-19)

Phase 1

• Conditions: Group 1: SARS-CoV-2-exposed subjects, as household members/contacts of COVID-19 patientsGroup 2: Patients with COVID-19 asymptomatic or paucisymptomatic in home situation; MedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001501-24-IT
• Lead Sponsor: ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-24
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2300

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified