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This is a Italian, superiority, open label cluster-randomised, interventional clinical trial aimed at assessing whether the treatment with Hydroxychloroquine can reduce the percentage of symptomatic subjects compared to observation only in household members/contacts of COVID-19 patients (Group 1) and if the treatment with Hydroxychloroquine could be introduced in early phase COVID-19 population (Group 2).
The participants will be randomised to receive either:
Arm A) hydroxychloroquine vs Arm B) Observation (2:1 randomisation).
Full description
This is an open label, superiority, cluster-randomized Italian interventional clinical trial, evaluating the role of Hydroxychloroquine versus observation only in preventing infection to COVID-19 or treating early phase COVID-19 patients.
Each index case is randomised to either Arm A: Hydroxychloroquine or Arm B: observation in a 2:1 ratio on an open label basis. Participants in the same cluster receive the same intervention.
Study population is constituted by:
Group 1: Severe Acute Respiratory Syndrome (SARS) - Corona Virus (CoV)-2-exposed subjects , as household members/contacts of COVID-19 patients.
Group 2: Patients with COVID-19 asymptomatic or paucisymptomatic in home situation.
Enrollment
Sex
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Volunteers
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:
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.
Primary purpose
Allocation
Interventional model
Masking
2,300 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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