Protect: Study With Hydroxychloroquine for Prevention and Early Phase Treatment of Coronavirus Disease (COVID-19) (PROTECT)
COVID19, Hydroxychloroquine, Prophylaxis
About this trial
This is an interventional treatment trial for COVID19 focused on measuring COVID19, Households, Hydroxychloroquine, prophylaxis, early phase treatment, prevention, asymptomatic, paucisymptomatic, home situation, SARS-CoV-2-exposed subjects
Eligibility Criteria
Inclusion Criteria:
- Male or Female, aged >= 18 years
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
- COVID-19 patients, asymptomatic or paucisymptomatic in home situation who are not in treatment with any anti COVID-19 medication (Group 2)
- Absence of any COVID-19 symptom in last week before randomization (fever >37.5°C, cough, dyspnea) (only for group 1 subjects)
- Paracetamol treatment is accepted only for group 2.
- 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.
Exclusion Criteria:
Reported anamnesis for:
- Intolerance or previous toxicity for hydroxychloroquine/chloroquine
- Bradycardia or reduction rhythm of heart with arrythmias
- Ischemic heart disease
- Retinopathy
- Congestive heart failure under/with use of diuretics
- Favism or glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Diabetes type 1
- Major comorbidities like advanced chronic kidney disease or dialysis therapy, known history of ventricular arrhythmias, any oncologic/hematologic malignancy.
- Severe neurological and mental illness
- Any other contraindication to take hydroxychloroquine
- Already taking chloroquine, hydroxychloroquine or analogous during the past 3 weeks
- Use of other antiviral agents in the last 3 weeks
- Subject with a positive test for SARS-CoV-2 (for Group 1)
- Pregnant or lactating
- Current use of medications with known significant drug-drug interactions: digoxin, hypoglycemic agents, anticonvulsant, Cyclosporine, Phenylbutazone, drugs that inhibit CYP2D6
- Known prolonged QT syndrome or current use of drugs with known QT prolongation
- Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
Sites / Locations
- Irst Irccs
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
No Intervention
Experimental
No Intervention
Group 1: Hydroxychloroquine
Group 1: Observation
Group 2: Hydroxycloroquine
Group 2: Observation
A loading dose Hydroxychloroquine 400 mg twice daily at day 1, followed by a weekly dose of Hydroxychloroquine 200 mg twice daily on days 8, 15 and 22, covering a total of 1 month of treatment.
observation only
A loading dose Hydroxychloroquine 400 mg twice daily at day 1 followed by 200 mg twice daily for a total of at least 5-7 days according to clinical evolution.
Observation only