Controlled and randomised trial to assess the safety and efficacy of hydroxychloroquine chemoprophylaxis in SARS CoV2 infection in hospital healthcare personnel (Sanitarios sin COVID-19).

Phase 1

• Conditions: SARS-CoV-2 infection (COVID-19); MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001704-42-ES
• Lead Sponsor: IDIVAL Instituto de Investigación Sanitaria Valdecilla

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-21
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

1) Healthcare professional aged between 18 and 65 (inclusive) at the time of the first selection visit.
2) Must provide a signed written informed consent and agree to adhere to the study protocol.
3) Active work in high exposure areas during the last two weeks and during the following weeks.
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 450
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Previous infection by SARS CoV2 (positive coronavirus PCR or positive IgG serology with negative SARS Cov2 PCR and absence of symptoms).
2) Current treatment with HCQ or chloroquine
3) Contraindication for taking HCQ (known epilepsy, porphyria, recent ischemic heart disease).
4) Previous or current treatment with tamoxifen or raloxifene.
5) Previous eye disease, especially maculopathy.
6) Known heart failure (Grade III-IV of the New York Heart Association classification) or prolonged QTc.
7) Any type of cancer (except basal cell) in the last 5 years.
6) Refusal to give informed consent.
8) Signs of any other untreated, unstable or clinically significant immunological, endocrine, hematological, gastrointestinal, neurological, neoplasic or psychiatric disease.
9) Positive antibodies to human immunodeficiency virus .
10) Significant kidney or liver disease.
11) Pregnancy or lactation
12) Hypersensitivity or allergy to HCQ, or any contraindication in Summary of Product Characteristics to HCQ intake.

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 prophylaxis with Hydroxychloroquine for 2 months versus placebo in the prevention and reduction of symptomatic and asymptomatic CoV-2 SARS infection in healthcare personnel.;Secondary Objective: 1) To evaluate the safety of HCQ during 2 months in the healthcare personnel.<br>2) To evaluate the number of working days lost as a result of symptomatic or asymptomatic infection by COVID19. <br>3) To analyse the percentage of severe respiratory illness due to COVID-19 in healthcare personnel. <br>4) To define the incidence, prevalence and severity of SARS CoV-2 infection in healthcare personnel in the hospital setting.;Primary end point(s): - Number of healthcare professionals with symptomatic or asymptomatic SARS-CoV2 infection.<br>- Severity of the infection.;Timepoint(s) of evaluation of this end point: 2 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Adverse effects of medication<br>- Number of working days lost to infection<br>- Incidence, prevalence and severity of SARS CoV-2 infection in healthcare professionals.;Timepoint(s) of evaluation of this end point: 2 months