Prevention of COVID19 Infection in Nursing Homes by Chemoprophylaxis With Hydroxychloroquine (PREVICHARM)
Status:
Not yet recruiting
Trial end date:
2021-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
University of Malaga
Collaborators:
Carlos III Health Institute Instituto de Investigacion Biomedica de Malaga