Clinical trial NCT04443270: Chloroquine Phosphate Prophylactic Use in Health Personnel Exposed to COVID-19 Patients
Official title: Efficacy of Chloroquine Phosphate Prophylactic Use in First-line Health Personnel Exposed to COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: COVID-19
Keywords: COVID-19
Chloroquine phosphate
Prophylactic
Health Personnel
Severe Acute Respiratory Syndrome Coronavirus-2
Lead sponsor: CMN "20 de Noviembre"
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Controlled Clinical Trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Negative Polymerase Chain Reaction assay at day 0
timeFrame: Day 0
measure: Polymerase Chain Reaction assay at day 60
timeFrame: Day 60
Secondary outcomes:
measure: Clinical improvement related to COVID-19
timeFrame: Baseline (day 0) and 30-day follow up
measure: Clinical improvement related to COVID-19
timeFrame: From 30-day to 60-day follow-up
measure: Heart rhythm negative adverse event related to the Chloroquine Phosphate Prophylactic Use
timeFrame: Baseline (day 0) and 30-day follow up
measure: Heart rhythm negative adverse event related to the Chloroquine Phosphate Prophylactic
timeFrame: From 30-day to 60-day follow-up
measure: COVID-19 symptomatic onset rate
timeFrame: From baseline (day 0) to 60-day follow up
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Centro Médico Nacional "20 de Noviembre"
state: Benito Juárez
Study officials:
affiliation: CMN "20 de Noviembre"
name: Sandra Muñoz-López, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: CMN "20 de Noviembre"
name: Sandra Muñoz-López, MD, MSc
role: STUDY_DIRECTOR
affiliation: CMN "20 de Noviembre"
name: Maricela Escarela-Serrano, MD
role: STUDY_CHAIR
affiliation: CMN "20 de Noviembre"
name: Fedra Irazoque-Palazuelos, MD
role: STUDY_CHAIR
affiliation: CMN "20 de Noviembre"
name: Luis Montiel-López, MD, MSc
role: STUDY_CHAIR
affiliation: CMN "20 de Noviembre"
name: Paul Mondragón-Terán, PhD
role: STUDY_CHAIR
affiliation: CMN "20 de Noviembre"
name: Alberto H De la Vega-Bravo, MD
role: STUDY_CHAIR
affiliation: CMN "20 de Noviembre"
name: Juan A Pineda-Juárez, PhD
role: STUDY_CHAIR
affiliation: CMN "20 de Noviembre"
name: Juan A Suárez-Cuenca, MD, PhD
role: STUDY_CHAIR
affiliation: CMN "20 de Noviembre"
name: Sofía L Alcaraz-Estrada, PhD
role: STUDY_CHAIR
affiliation: CMN "20 de Noviembre"
name: Eduardo Soei-Sarmiento, BsC
role: STUDY_CHAIR
affiliation: CMN "20 de Noviembre"
name: Maribel Santosbeña-Lagunes, MD
role: STUDY_CHAIR
affiliation: CMN "20 de Noviembre"
name: Joel Vargas-Hernández, MD
role: STUDY_CHAIR
affiliation: CMN "20 de Noviembre"
name: Carlos A Delgado-Quintana, MD
role: STUDY_CHAIR
affiliation: CMN "20 de Noviembre"
name: Alejandro Alanis-Vega, MD
role: STUDY_CHAIR
affiliation: CMN "20 de Noviembre"
name: Ricardo P Vázquez-Alvarado, MD
role: STUDY_CHAIR
affiliation: CMN "20 de Noviembre"
name: Mireya Rodríguez-Martínez, MD
role: STUDY_CHAIR
affiliation: CMN "20 de Noviembre"
name: María C Méndez-Vidrio, MD
role: STUDY_CHAIR
affiliation: CMN "20 de Noviembre"
name: Fidel Cerda-Tellez, MD
role: STUDY_CHAIR
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