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

NCT ID: NCT04443270

Last Updated: 2020-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-27
• Study Completion Date: 2021-01-31

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.

Conditions

COVID-19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Chloroquine phosphate prophylactic group

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.

Group Type: EXPERIMENTAL

Chloroquine phosphate

Intervention Type: DRUG

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.

Control group

Health personnel who want to be included voluntary in the study and meet the inclusion criteria without Chloroquine use.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Plasmodín

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CMN "20 de Noviembre"

OTHER

Sponsor Role: lead

Responsible Party

Sandra Muñoz López

Internal Medicine Service Member, MD, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandra Muñoz-López, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

CMN "20 de Noviembre"

Sandra Muñoz-López, MD, MSc

Role: STUDY_DIRECTOR

CMN "20 de Noviembre"

Maricela Escarela-Serrano, MD

Role: STUDY_CHAIR

CMN "20 de Noviembre"

Fedra Irazoque-Palazuelos, MD

Role: STUDY_CHAIR

CMN "20 de Noviembre"

Luis Montiel-López, MD, MSc

Role: STUDY_CHAIR

CMN "20 de Noviembre"

Paul Mondragón-Terán, PhD

Role: STUDY_CHAIR

CMN "20 de Noviembre"

Alberto H De la Vega-Bravo, MD

Role: STUDY_CHAIR

CMN "20 de Noviembre"

Juan A Pineda-Juárez, PhD

Role: STUDY_CHAIR

CMN "20 de Noviembre"

Juan A Suárez-Cuenca, MD, PhD

Role: STUDY_CHAIR

CMN "20 de Noviembre"

Sofía L Alcaraz-Estrada, PhD

Role: STUDY_CHAIR

CMN "20 de Noviembre"

Eduardo Soei-Sarmiento, BsC

Role: STUDY_CHAIR

CMN "20 de Noviembre"

Maribel Santosbeña-Lagunes, MD

Role: STUDY_CHAIR

CMN "20 de Noviembre"

Joel Vargas-Hernández, MD

Role: STUDY_CHAIR

CMN "20 de Noviembre"

Carlos A Delgado-Quintana, MD

Role: STUDY_CHAIR

CMN "20 de Noviembre"

Alejandro Alanis-Vega, MD

Role: STUDY_CHAIR

CMN "20 de Noviembre"

Ricardo P Vázquez-Alvarado, MD

Role: STUDY_CHAIR

CMN "20 de Noviembre"

Mireya Rodríguez-Martínez, MD

Role: STUDY_CHAIR

CMN "20 de Noviembre"

María C Méndez-Vidrio, MD

Role: STUDY_CHAIR

CMN "20 de Noviembre"

Fidel Cerda-Tellez, MD

Role: STUDY_CHAIR

CMN "20 de Noviembre"

Locations

Centro Médico Nacional "20 de Noviembre"

Mexico City, Benito Juárez, Mexico

Countries

Mexico

Central Contacts

Sandra Muñoz-López, MD, MSc

Role: CONTACT

ssanml@yahoo.com.mx

+52 55 52 00 5003 ext. 14240

Juan A Suárez-Cuenca, MD, PhD

Role: CONTACT

juan.suarezcue@issste.gob.mx

+52 55 52 00 5003 ext. 14661

Facility Contacts

Sandra Muñoz-López, MD, MSc

Role: primary

ssanml@yahoo.com.mx

+52 55 5200 5003 ext. 14240

Juan A Suárez-Cuenca, MD, PhD

Role: backup

juan.suarezcue@issste.gob.mx

+52 55 5200 5003 ext. 14661

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Related Links

https://www.who.int/emergencies/diseases/novel-coronavirus-2019

World Health Organization. Coronavirus disease (COVID-19) outbreak situation.

https://www.who.int/emergencies/diseases/novel-coronavirus-2019/events-as-they-happen

World Health Organization. Rolling updates on coronavirus disease (COVID-19).

https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or

FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems. 2020.

Other Identifiers

01

Identifier Type: -

Identifier Source: org_study_id