Healthcare personnel at risk of SARS-CoV-2 infection MedDRA version: 23.0 Level: LLT Classification code 10053983 Term: Corona virus infection System Organ Class: 100000004862 MedDRA version: 20.0 Level: LLT Classification code 10061986 Term: SARS System Organ Class: 100000004862
Conditions
Interventions
Product Name: IDROSSICLOROCHINA SOLFATO
Product Code: [IDROSSICLOROCHINA SOLFATO]
Pharmaceutical Form: Coated tablet
INN or Proposed INN: IDROSSICLOROCHINA SOLFATO
CAS Number: 118-42-3
Current Sponsor
Sponsors
OSPEDALE SAN RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent for participation to the study 2. Age between 18 and 70 years 3. RT-PCR negative for SARS-CoV-2 4. Antibody test for negative SARS-CoV-2 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 950 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Presence of co-morbidity or concomitant intake of drugs that can interfere with the risk of contracting the infection or influence its course: diabetes, heart failure, neoplastic pathologies, etc.) 2. Immunoactive treatments ongoing 3.State of pregnancy or breastfeeding 4. Contraindications to the use of hydroxychloroquine: History of hypersensitivity or allergy to hydroxychloroquine b.Deficit of glucose-6 phosphate dehydrogenase c.Porfiria d.Psoriasi e.Weight <40 kg f) Previously referred to as retinopathy or visual field disturbances or concomitant intake of drugs known to induce retinopathy (e.g. tamoxifen) g. Previous ventricular cardiac dysrhythmias or proarrhythmic conditions (e.g. bpm <50 / min) h. Concomitant use of digoxin or drugs known to prolong the QT interval (class IA and III antiarrhythmics, tricyclic antidepressants, antipsychotics, halofantrine), insulin or oral hypoglycaemic agents, phenylbutazone, cyclosporine, mefloquine or other antimalarial drugs, anti-septal drugs I. severe chronic renal failure (creatinine clearance <10 ml / min) 5. Hydroxychloroquine treatment at any dose, and for any duration and motivation in the last 6 months 6. Previous diagnosis of COVID-19 or previous symptoms suggestive of disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of the preventive treatment with hydroxychloroquine in reducing the risk of SARS-CoV-2 infection in healthcare workers at risk;Secondary Objective: •To evaluate the efficacy of the preventive treatment with hydroxychloroquine in reducing the severity of COVID-19 clinical manifestations •To evaluate the safety and tolerability of hydroxychloroquine as a prophylaxis treatment for SARS-CoV-2;Primary end point(s): •Proportion of hydroxychloroquine treated subjects treated with SARS-CoV-2 positive nasopharyngeal swab compared to controls;Timepoint(s) of evaluation of this end point: At days +14 and +28 from the start of the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of hydroxychloroquine treated subjects admitted to an intensive care unit for COVID-19, compared to controls; • Proportion of hydroxychloroquine treated subjects interstitial pneumonia typical of COVID-19, compared to controls; • Proportion of adverse and severe adverse events in hydroxychloroquine treated subjects compared to controls; • Proportion of hydroxychloroquine treated subjects with two or more typical COVID-19 clinical manifestations (dry cough, dyspnoea, fever, pharyngodynia, myalgias, dysgeusia or anosmia, conjunctivitis, nausea, vomiting or diarrhea), compared to controls; • Proportion of hydroxychloroquine treated subjects with SARS-CoV-2 specific antibodies, compared to controls; • Proportion of hydroxychloroquine treated subjects hospitalized for COVID-19, compared to controls;Timepoint(s) of evaluation of this end point: At day +14, +28 and +42 from the start of the treatment with hydroxychloroquine; At day +14, +28 and +42 from the start of the treatment with hydroxychloroquine; At day +14, +28 and +42 from the start of the treatment with hydroxychloroquine; At day +14, +28 and +42 from the start of the treatment with hydroxychloroquine; At day 28 + 14 from the start of treatment with hydroxychloroquine; At day +14, +28 and +42 from the start of the treatment with hydroxychloroquine | — |
Countries
Italy
Contacts
Public ContactIRCCS Ospedale San Raffaele
IRCCS Ospedale San Raffaele
Outcome results
None listed