Status:
TERMINATED
Protect: Study With Hydroxychloroquine for Prevention and Early Phase Treatment of Coronavirus Disease (COVID-19)
Lead Sponsor:
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Collaborating Sponsors:
University of Bologna
Conditions:
COVID19
Hydroxychloroquine
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 s...
Detailed 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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT04363827
Start Date
May 14 2020
End Date
September 30 2021
Last Update
March 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Irst Irccs
Meldola, FC, Italy, 47014