PRECOV: a randomized controlled clinical trial on the effects of hydroxychloroquine in the prevention of COVID-19 in healthcare workers at risk

Phase 1

• Conditions: Healthcare personnel at risk of SARS-CoV-2 infection; MedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862; MedDRA version: 20.0Level: LLTClassification code 10061986Term: SARSSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001987-28-IT
• Lead Sponsor: OSPEDALE SAN RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-24
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1000

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>•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