Protect: Study With Hydroxychloroquine for Prevention and Early Phase Treatment of Coronavirus Disease (COVID-19)

• Status: Active, not recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

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 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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Collaborator: University of Bologna
• Treatments: Hydroxychloroquine

Criteria

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.

Exclusion Criteria:

1. Reported anamnesis for:

1. Intolerance or previous toxicity for hydroxychloroquine/chloroquine

2. Bradycardia or reduction rhythm of heart with arrythmias

3. Ischemic heart disease

4. Retinopathy

5. Congestive heart failure under/with use of diuretics

6. Favism or glucose-6-phosphate dehydrogenase (G6PD) deficiency

7. Diabetes type 1

8. Major comorbidities like advanced chronic kidney disease or dialysis therapy, known history of ventricular arrhythmias, any oncologic/hematologic malignancy.

9. 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. Subject with a positive test for SARS-CoV-2 (for Group 1)

6. Pregnant or lactating

7. Current use of medications with known significant drug-drug interactions: digoxin, hypoglycemic agents, anticonvulsant, Cyclosporine, Phenylbutazone, drugs that inhibit CYP2D6

8. Known prolonged QT syndrome or current use of drugs with known QT prolongation

9. Participation in another clinical trial with any investigational agents within 30 days prior to study screening.