Prevention of COVID19 Infection in Nursing Homes by Chemoprophylaxis With Hydroxychloroquine (PREVICHARM)

Summary

Professionals and residents of nursing homes are one of the most vulnerable groups in this public health crisis of COVID-19, since they have the highest rate of positives for COVID-19, despite the restriction measures carried out, such as prohibition of family visits to these centers, the infection occurs by cross transmission with the care staff of the centers, or with other residents.

At the moment, there are no clinical trials to test the hypothesis that hydroxychloroquine is effective in coronavirus treatment. Although what has been observed is a better prognosis in infected patients, since this drug inhibits the replication of the virus and its expansion to other tissues.

This study is a clinical trial to test the effectiveness of hydroxychloroquine as a preventive drug for SARS-CoV-2 infection. This drug will be applied to 1050 people residing in nursing home care and 880 professionals who work in close contact with these people and who have not yet contracted the infection.

This project will be carried out in the territories of Madrid, Navarra, Aragon and Andalusia (Spain).

Hydroxychloroquine is a widely known drug that is used in two scenarios, against autoimmune diseases, such as lupus or rheumatoid arthritis, and as an antimalarial drug.

It is also intended to demonstrate that the presumed reduction in viral load that would be obtained with hydroxychloroquine prophylaxis, would have no effect in development of immunity against the virus. This fact can create a new paradigm for the de-escalation of the confinement to which the population has been subjected to stop the virus spread, allowing the development of general immunity in controlled populations until reaching total immunity.

In addition to testing the effect of this drug, a non-pharmacological intervention based on a safety record will be tested in the management of infection on nursing home, to assess its effectiveness in detecting risk areas or bad practices carried out in this vulnerable environment.

The study is led by researchers of the Institute of Biomedicine of Malaga (Spain), and has obtained a financing of 1,024,199 euros from Carlos III Health Institute (Spain).

The period of execution of the clinical trial is one year, and with this intervention, the intention is to reduce cross-infection in residents by a minimum threshold of 15%, as well as to decrease infection in the professionals.

Conditions

• Sars-CoV2
• Coronavirus Infection
• Prevention & Control
• Nursing Home
• Hydroxychloroquine

Interventions

DRUG

Hydroxychloroquine Only Product in Oral Dose Form

The dose to be used as chemoprophylaxis will be 800mg of HCQ on the first day and 400mg for the following four days.

Sponsors & Collaborators

• Instituto de Investigacion Biomedica de Malaga

  collaborator OTHER

• Carlos III Health Institute

  collaborator OTHER_GOV

• University of Malaga

  lead OTHER

Principal Investigators

• José M Morales-Asencio, PhD · University of Malaga; Malaga, Spain.

• Ricardo Gómez-Huelgas, PhD · Hospital Regional de Malaga

• Juan C Morilla-Herrera, PhD · Distrito de Atención Primaria Málaga-Valle del Guadalhorce

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-09-30

Primary Completion

2020-12-15

Completion

2021-04-01