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

July 13, 2020 updated by: Sandra Muñoz López, CMN "20 de Noviembre"

Efficacy of Chloroquine Phosphate Prophylactic Use in First-line Health Personnel Exposed to COVID-19 Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sandra Muñoz-López, MD, MSc
  • Phone Number: 14240 +52 55 52 00 5003
  • Email: ssanml@yahoo.com.mx

Study Contact Backup

Study Locations

  • Mexico
    • Benito Juárez
      • Mexico City, Benito Juárez, Mexico, 03229
        • Centro Médico Nacional "20 de Noviembre"
        • Contact:
          • Sandra Muñoz-López, MD, MSc
          • Phone Number: 14240 +52 55 5200 5003
          • Email: ssanml@yahoo.com.mx
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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 Names:
  • Plasmodín
No Intervention: Control group
Health personnel who want to be included voluntary in the study and meet the inclusion criteria without Chloroquine use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negative Polymerase Chain Reaction assay at day 0
Time Frame: Day 0
Prior to the participation of each health worker, a pharyngeal exudate sample will be taken with a swab. RNA will be obtained by applying severe acute respiratory syndrome coronavirus-2 real time polymerase chain reaction kit, using specific oligonucleotides in polymerase chain reaction.
Day 0
Polymerase Chain Reaction assay at day 60
Time Frame: Day 60
A pharyngeal exudate sample will be taken with a swab. RNA will be obtained by applying severe acute respiratory syndrome coronavirus-2 real time polymerase chain reaction kit, using specific oligonucleotides in polymerase chain reaction.
Day 60

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical improvement related to COVID-19
Time Frame: Baseline (day 0) and 30-day follow up

Ordinal Scale for Clinical Improvement according the "World Health Organization R&D Blueprint novel Coronavirus COVID-19 Therapeutic Trial Synopsis" will apply at baseline and 30-day follow-up as follows:

No clinical or virological evidence of infection = 0 No limitation of activities = 1 Limitation of activities = 2 Hospitalized, no oxygen therapy = 3 Oxygen by mask or nasal prongs = 4 Non-invasive ventilation or high-flow oxygen = 5 Intubation and mechanical ventilation - Score = 6 Ventilation + additional organ support-pressors, renal replacement therapy, extracorporeal membrane oxygenation = 7 Death = 8
Baseline (day 0) and 30-day follow up
Clinical improvement related to COVID-19
Time Frame: From 30-day to 60-day follow-up

Ordinal Scale for Clinical Improvement according the "World Health Organization R&D Blueprint novel Coronavirus COVID-19 Therapeutic Trial Synopsis" will apply at baseline and 30-day follow-up as follows:

No clinical or virological evidence of infection = 0 No limitation of activities = 1 Limitation of activities = 2 Hospitalized, no oxygen therapy = 3 Oxygen by mask or nasal prongs = 4 Non-invasive ventilation or high-flow oxygen = 5 Intubation and mechanical ventilation - Score = 6 Ventilation + additional organ support-pressors, renal replacement therapy, extracorporeal membrane oxygenation = 7 Death = 88
From 30-day to 60-day follow-up
Heart rhythm negative adverse event related to the Chloroquine Phosphate Prophylactic Use
Time Frame: Baseline (day 0) and 30-day follow up

An EKG will be performed to measure QT interval at baseline and 30-day follow-up.

The EKG follows the standards and guidelines established by the Centro Médico Nacional "20 de Noviembre."
Baseline (day 0) and 30-day follow up
Heart rhythm negative adverse event related to the Chloroquine Phosphate Prophylactic
Time Frame: From 30-day to 60-day follow-up

An EKG will be performed to measure QT interval at 60-day follow-up.

The EKG follows the standards and guidelines established by the Centro Médico Nacional "20 de Noviembre."
From 30-day to 60-day follow-up
COVID-19 symptomatic onset rate
Time Frame: From baseline (day 0) to 60-day follow up
According to the National Committee for Epidemiological Surveillance (CONAVE) in Mexico, COVID-19 symptomatic onset rate defined as the presence of cough, fever or headache during the last 7 days, accompanied at least one of the following symptoms: dyspnea, arthralgia, myalgia, odynophagia / pharyngeal burning, rhinorrhea, conjunctivitis or chest pain.
From baseline (day 0) to 60-day follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CMN "20 de Noviembre"

Investigators

  • Principal Investigator: Sandra Muñoz-López, MD, MSc, CMN "20 de Noviembre"
  • Study Director: Sandra Muñoz-López, MD, MSc, CMN "20 de Noviembre"
  • Study Chair: Maricela Escarela-Serrano, MD, CMN "20 de Noviembre"
  • Study Chair: Fedra Irazoque-Palazuelos, MD, CMN "20 de Noviembre"
  • Study Chair: Luis Montiel-López, MD, MSc, CMN "20 de Noviembre"
  • Study Chair: Paul Mondragón-Terán, PhD, CMN "20 de Noviembre"
  • Study Chair: Alberto H De la Vega-Bravo, MD, CMN "20 de Noviembre"
  • Study Chair: Juan A Pineda-Juárez, PhD, CMN "20 de Noviembre"
  • Study Chair: Juan A Suárez-Cuenca, MD, PhD, CMN "20 de Noviembre"
  • Study Chair: Sofía L Alcaraz-Estrada, PhD, CMN "20 de Noviembre"
  • Study Chair: Eduardo Soei-Sarmiento, BsC, CMN "20 de Noviembre"
  • Study Chair: Maribel Santosbeña-Lagunes, MD, CMN "20 de Noviembre"
  • Study Chair: Joel Vargas-Hernández, MD, CMN "20 de Noviembre"
  • Study Chair: Carlos A Delgado-Quintana, MD, CMN "20 de Noviembre"
  • Study Chair: Alejandro Alanis-Vega, MD, CMN "20 de Noviembre"
  • Study Chair: Ricardo P Vázquez-Alvarado, MD, CMN "20 de Noviembre"
  • Study Chair: Mireya Rodríguez-Martínez, MD, CMN "20 de Noviembre"
  • Study Chair: María C Méndez-Vidrio, MD, CMN "20 de Noviembre"
  • Study Chair: Fidel Cerda-Tellez, MD, CMN "20 de Noviembre"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 27, 2020

Primary Completion (Anticipated)

October 31, 2020

Study Completion (Anticipated)

January 31, 2021

Study Registration Dates

First Submitted

June 17, 2020

First Submitted That Met QC Criteria

June 22, 2020

First Posted (Actual)

June 23, 2020

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01 (Miami VAHS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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