Chloroquine Phosphate Prophylactic Use in Health Personnel Exposed to COVID-19 Patients

CMN "20 de Noviembre"

Status and phase

Unknown

Phase 1

Conditions

COVID-19

Treatments

Drug: Chloroquine phosphate

Study type

Interventional

Funder types

Other

Identifiers

NCT04443270

Details and patient eligibility

About

The primary objective of this study is to evaluate the efficacy and security of chloroquine phosphate prophylactic use for reducing the risk of infection by severe acute respiratory syndrome coronavirus-2 in Health Care Workers exposed to COVID-19 patients.

Full description

Health Care Workers as first line of hospital care, are at high risk of infection by severe acute respiratory syndrome coronavirus-2 due for the exposure to COVID-19 patients. The pharmacological treatment with chloroquine phosphate has emerged as one of the main therapeutic approaches for COVID-19 patients. However, some studies have described and hypothesized that the use of prophylactic chloroquine phosphate could provide some protection against COVID-19 infection reducing the chances of contagion in Health Care personnel during the development of the pandemic. A controlled clinical trial will be conducted in a tertiary hospital in Mexico City, Mexico. Participants will be divide in two groups; 1) intervention: who will receive chloroquine phosphate (300 mg/day during the first 30 days and 150mg/day during the last 30 days) and 2) control, both with a follow up for 60 days.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 59 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Health Care Workers as first line of hospital care exposed to COVID-19 patients.
Initial polymerase chain reaction assay negative test for severe acute respiratory syndrome coronavirus-2 infection.
Both sexes
Agree to participate in the study after signing an informed consent letter.

Exclusion criteria

Health Care Workers as first line of hospital care exposed to COVID-19 patients with history of heart disease, arrhythmias or QT segment prolongation.
Health Care Workers as first line of hospital care exposed to COVID-19 patients with liver or kidney disease of any etiology.
Health Care Workers as first line of hospital care exposed to COVID-19 patients with retinopathy of any etiology.
Health Care Workers as first line of hospital care exposed to COVID-19 patients with allergy to chloroquine.
Health Care Workers as first line of hospital care exposed to COVID-19 patients with a history or diagnosis of psoriasis.
Health Care Workers as first line of hospital care exposed to COVID-19 patients with important primary clinical alterations: renal (creatinine> 3), liver (Alanine Aminotransferase and Aspartate Aminotransferase x 3), endocrine, neurological.