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

Sponsor
CMN "20 de Noviembre" (Other)
Overall Status
Unknown status
CT.gov ID
NCT04443270
Collaborator
(none)
200
1
2
6.2
32.4

Study Details

Study Description

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
  • 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

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Controlled Clinical TrialControlled 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
Anticipated Study Start Date :
Jul 27, 2020
Anticipated Primary Completion Date :
Oct 31, 2020
Anticipated Study Completion Date :
Jan 31, 2021

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Negative Polymerase Chain Reaction assay at day 0 [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 [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 [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 [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 [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 [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years to 59 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Centro Médico Nacional "20 de Noviembre" Mexico City Benito Juárez Mexico 03229

    Sponsors and Collaborators

    • 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"

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    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:
    Jun 23, 2020
    Last Update Posted:
    Jul 14, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sandra Muñoz López, Internal Medicine Service Member, MD, MSc, CMN "20 de Noviembre"
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 14, 2020