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.
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.
Drug: Chloroquine phosphate
Drug: Chloroquine phosphate
Dosage form, frequency and duration: 300 mg per day during initial 30 days and 150 mg per day during the next 30 days.
Other Name: Plasmodín
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.
Centro Médico Nacional "20 de Noviembre"
Mexico City, Benito Juárez, Mexico
Investigator: Sandra Muñoz-López, MD, MSc
Contact: +52 55 5200 5003
ssanml@yahoo.com.mx
Sandra Muñoz-López, MD, MSc
+52 55 52 00 5003 - 14240
ssanml@yahoo.com.mx
Juan A Suárez-Cuenca, MD, PhD
+52 55 52 00 5003 - 14661
juan.suarezcue@issste.gob.mx