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

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ClinicalTrials.gov Identifier: NCT04443270
Recruitment Status : Not yet recruiting
First Posted : June 23, 2020
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Sandra Muñoz López, CMN "20 de Noviembre"

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Chloroquine phosphate Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Controlled Clinical Trial
Masking: Single (Outcomes Assessor)
Masking Description: The Outcome Assessor will be an external member of the Internal Medicine Service, which will be blinded to the intervention.
Primary Purpose: Prevention
Official Title: Efficacy of Chloroquine Phosphate Prophylactic Use in First-line Health Personnel Exposed to COVID-19 Patients
Estimated Study Start Date : July 27, 2020
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Plasmodín
No Intervention: Control group
Health personnel who want to be included voluntary in the study and meet the inclusion criteria without Chloroquine use.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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


  2. 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


  3. 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."


  4. 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."


  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04443270


Contacts
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Contact: Sandra Muñoz-López, MD, MSc +52 55 52 00 5003 ext 14240 ssanml@yahoo.com.mx
Contact: Juan A Suárez-Cuenca, MD, PhD +52 55 52 00 5003 ext 14661 juan.suarezcue@issste.gob.mx

Locations
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Mexico
Centro Médico Nacional "20 de Noviembre"
Mexico City, Benito Juárez, Mexico, 03229
Contact: Sandra Muñoz-López, MD, MSc    +52 55 5200 5003 ext 14240    ssanml@yahoo.com.mx   
Contact: Juan A Suárez-Cuenca, MD, PhD    +52 55 5200 5003 ext 14661    juan.suarezcue@issste.gob.mx   
Sponsors and Collaborators
CMN "20 de Noviembre"
Investigators
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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"
More Information
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Additional Information:

Publications:

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Responsible Party: Sandra Muñoz López, Internal Medicine Service Member, MD, MSc, CMN "20 de Noviembre"
ClinicalTrials.gov Identifier: NCT04443270    
Other Study ID Numbers: 01
First Posted: June 23, 2020    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sandra Muñoz López, CMN "20 de Noviembre":
COVID-19
Chloroquine phosphate
Prophylactic
Health Personnel
Severe Acute Respiratory Syndrome Coronavirus-2
Additional relevant MeSH terms:
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Chloroquine
Chloroquine diphosphate
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics