<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04443270</url>
  </required_header>
  <id_info>
    <org_study_id>01</org_study_id>
    <nct_id>NCT04443270</nct_id>
  </id_info>
  <brief_title>Chloroquine Phosphate Prophylactic Use in Health Personnel Exposed to COVID-19 Patients</brief_title>
  <official_title>Efficacy of Chloroquine Phosphate Prophylactic Use in First-line Health Personnel Exposed to COVID-19 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CMN &quot;20 de Noviembre&quot;</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CMN &quot;20 de Noviembre&quot;</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to evaluate the efficacy and security of chloroquine&#xD;
      phosphate prophylactic use for reducing the risk of infection by severe acute respiratory&#xD;
      syndrome coronavirus-2 in Health Care Workers exposed to COVID-19 patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Health Care Workers as first line of hospital care, are at high risk of infection by severe&#xD;
      acute respiratory syndrome coronavirus-2 due for the exposure to COVID-19 patients. The&#xD;
      pharmacological treatment with chloroquine phosphate has emerged as one of the main&#xD;
      therapeutic approaches for COVID-19 patients. However, some studies have described and&#xD;
      hypothesized that the use of prophylactic chloroquine phosphate could provide some protection&#xD;
      against COVID-19 infection reducing the chances of contagion in Health Care personnel during&#xD;
      the development of the pandemic. A controlled clinical trial will be conducted in a tertiary&#xD;
      hospital in Mexico City, Mexico. Participants will be divide in two groups; 1) intervention:&#xD;
      who will receive chloroquine phosphate (300 mg/day during the first 30 days and 150mg/day&#xD;
      during the last 30 days) and 2) control, both with a follow up for 60 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 27, 2020</start_date>
  <completion_date type="Anticipated">January 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Controlled Clinical Trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The Outcome Assessor will be an external member of the Internal Medicine Service, which will be blinded to the intervention.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Negative Polymerase Chain Reaction assay at day 0</measure>
    <time_frame>Day 0</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Polymerase Chain Reaction assay at day 60</measure>
    <time_frame>Day 60</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical improvement related to COVID-19</measure>
    <time_frame>Baseline (day 0) and 30-day follow up</time_frame>
    <description>Ordinal Scale for Clinical Improvement according the &quot;World Health Organization R&amp;D Blueprint novel Coronavirus COVID-19 Therapeutic Trial Synopsis&quot; will apply at baseline and 30-day follow-up as follows:&#xD;
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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical improvement related to COVID-19</measure>
    <time_frame>From 30-day to 60-day follow-up</time_frame>
    <description>Ordinal Scale for Clinical Improvement according the &quot;World Health Organization R&amp;D Blueprint novel Coronavirus COVID-19 Therapeutic Trial Synopsis&quot; will apply at baseline and 30-day follow-up as follows:&#xD;
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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rhythm negative adverse event related to the Chloroquine Phosphate Prophylactic Use</measure>
    <time_frame>Baseline (day 0) and 30-day follow up</time_frame>
    <description>An EKG will be performed to measure QT interval at baseline and 30-day follow-up.&#xD;
The EKG follows the standards and guidelines established by the Centro Médico Nacional &quot;20 de Noviembre.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rhythm negative adverse event related to the Chloroquine Phosphate Prophylactic</measure>
    <time_frame>From 30-day to 60-day follow-up</time_frame>
    <description>An EKG will be performed to measure QT interval at 60-day follow-up.&#xD;
The EKG follows the standards and guidelines established by the Centro Médico Nacional &quot;20 de Noviembre.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>COVID-19 symptomatic onset rate</measure>
    <time_frame>From baseline (day 0) to 60-day follow up</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Chloroquine phosphate prophylactic group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: Chloroquine phosphate&#xD;
Dosage form, frequency and duration: 300 mg per day during initial 30 days and 150 mg per day during the next 30 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Health personnel who want to be included voluntary in the study and meet the inclusion criteria without Chloroquine use.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chloroquine phosphate</intervention_name>
    <description>Drug: Chloroquine phosphate&#xD;
Dosage form, frequency and duration: 300 mg per day during initial 30 days and 150 mg per day during the next 30 days.</description>
    <arm_group_label>Chloroquine phosphate prophylactic group</arm_group_label>
    <other_name>Plasmodín</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Health Care Workers as first line of hospital care exposed to COVID-19 patients.&#xD;
&#xD;
          -  Initial polymerase chain reaction assay negative test for severe acute respiratory&#xD;
             syndrome coronavirus-2 infection.&#xD;
&#xD;
          -  Both sexes&#xD;
&#xD;
          -  Agree to participate in the study after signing an informed consent letter.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Health Care Workers as first line of hospital care exposed to COVID-19 patients with&#xD;
             history of heart disease, arrhythmias or QT segment prolongation.&#xD;
&#xD;
          -  Health Care Workers as first line of hospital care exposed to COVID-19 patients with&#xD;
             liver or kidney disease of any etiology.&#xD;
&#xD;
          -  Health Care Workers as first line of hospital care exposed to COVID-19 patients with&#xD;
             retinopathy of any etiology.&#xD;
&#xD;
          -  Health Care Workers as first line of hospital care exposed to COVID-19 patients with&#xD;
             allergy to chloroquine.&#xD;
&#xD;
          -  Health Care Workers as first line of hospital care exposed to COVID-19 patients with a&#xD;
             history or diagnosis of psoriasis.&#xD;
&#xD;
          -  Health Care Workers as first line of hospital care exposed to COVID-19 patients with&#xD;
             important primary clinical alterations: renal (creatinine&gt; 3), liver (Alanine&#xD;
             Aminotransferase and Aspartate Aminotransferase x 3), endocrine, neurological.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandra Muñoz-López, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>CMN &quot;20 de Noviembre&quot;</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sandra Muñoz-López, MD, MSc</last_name>
    <role>Study Director</role>
    <affiliation>CMN &quot;20 de Noviembre&quot;</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maricela Escarela-Serrano, MD</last_name>
    <role>Study Chair</role>
    <affiliation>CMN &quot;20 de Noviembre&quot;</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fedra Irazoque-Palazuelos, MD</last_name>
    <role>Study Chair</role>
    <affiliation>CMN &quot;20 de Noviembre&quot;</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Luis Montiel-López, MD, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>CMN &quot;20 de Noviembre&quot;</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paul Mondragón-Terán, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>CMN &quot;20 de Noviembre&quot;</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alberto H De la Vega-Bravo, MD</last_name>
    <role>Study Chair</role>
    <affiliation>CMN &quot;20 de Noviembre&quot;</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Juan A Pineda-Juárez, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>CMN &quot;20 de Noviembre&quot;</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Juan A Suárez-Cuenca, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>CMN &quot;20 de Noviembre&quot;</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sofía L Alcaraz-Estrada, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>CMN &quot;20 de Noviembre&quot;</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eduardo Soei-Sarmiento, BsC</last_name>
    <role>Study Chair</role>
    <affiliation>CMN &quot;20 de Noviembre&quot;</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maribel Santosbeña-Lagunes, MD</last_name>
    <role>Study Chair</role>
    <affiliation>CMN &quot;20 de Noviembre&quot;</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joel Vargas-Hernández, MD</last_name>
    <role>Study Chair</role>
    <affiliation>CMN &quot;20 de Noviembre&quot;</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carlos A Delgado-Quintana, MD</last_name>
    <role>Study Chair</role>
    <affiliation>CMN &quot;20 de Noviembre&quot;</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alejandro Alanis-Vega, MD</last_name>
    <role>Study Chair</role>
    <affiliation>CMN &quot;20 de Noviembre&quot;</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ricardo P Vázquez-Alvarado, MD</last_name>
    <role>Study Chair</role>
    <affiliation>CMN &quot;20 de Noviembre&quot;</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mireya Rodríguez-Martínez, MD</last_name>
    <role>Study Chair</role>
    <affiliation>CMN &quot;20 de Noviembre&quot;</affiliation>
  </overall_official>
  <overall_official>
    <last_name>María C Méndez-Vidrio, MD</last_name>
    <role>Study Chair</role>
    <affiliation>CMN &quot;20 de Noviembre&quot;</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fidel Cerda-Tellez, MD</last_name>
    <role>Study Chair</role>
    <affiliation>CMN &quot;20 de Noviembre&quot;</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sandra Muñoz-López, MD, MSc</last_name>
    <phone>+52 55 52 00 5003</phone>
    <phone_ext>14240</phone_ext>
    <email>ssanml@yahoo.com.mx</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Juan A Suárez-Cuenca, MD, PhD</last_name>
    <phone>+52 55 52 00 5003</phone>
    <phone_ext>14661</phone_ext>
    <email>juan.suarezcue@issste.gob.mx</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centro Médico Nacional &quot;20 de Noviembre&quot;</name>
      <address>
        <city>Mexico City</city>
        <state>Benito Juárez</state>
        <zip>03229</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <contact>
      <last_name>Sandra Muñoz-López, MD, MSc</last_name>
      <phone>+52 55 5200 5003</phone>
      <phone_ext>14240</phone_ext>
      <email>ssanml@yahoo.com.mx</email>
    </contact>
    <contact_backup>
      <last_name>Juan A Suárez-Cuenca, MD, PhD</last_name>
      <phone>+52 55 5200 5003</phone>
      <phone_ext>14661</phone_ext>
      <email>juan.suarezcue@issste.gob.mx</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <link>
    <url>https://www.who.int/emergencies/diseases/novel-coronavirus-2019</url>
    <description>World Health Organization. Coronavirus disease (COVID-19) outbreak situation.</description>
  </link>
  <link>
    <url>https://www.who.int/emergencies/diseases/novel-coronavirus-2019/events-as-they-happen</url>
    <description>World Health Organization. Rolling updates on coronavirus disease (COVID-19).</description>
  </link>
  <link>
    <url>https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or</url>
    <description>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.</description>
  </link>
  <reference>
    <citation>Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020 May;109:102433. doi: 10.1016/j.jaut.2020.102433. Epub 2020 Feb 26.</citation>
    <PMID>32113704</PMID>
  </reference>
  <reference>
    <citation>Adhikari SP, Meng S, Wu YJ, Mao YP, Ye RX, Wang QZ, Sun C, Sylvia S, Rozelle S, Raat H, Zhou H. Epidemiology, causes, clinical manifestation and diagnosis, prevention and control of coronavirus disease (COVID-19) during the early outbreak period: a scoping review. Infect Dis Poverty. 2020 Mar 17;9(1):29. doi: 10.1186/s40249-020-00646-x.</citation>
    <PMID>32183901</PMID>
  </reference>
  <reference>
    <citation>Singhal T. A Review of Coronavirus Disease-2019 (COVID-19). Indian J Pediatr. 2020 Apr;87(4):281-286. doi: 10.1007/s12098-020-03263-6. Epub 2020 Mar 13.</citation>
    <PMID>32166607</PMID>
  </reference>
  <reference>
    <citation>Sohrabi C, Alsafi Z, O'Neill N, Khan M, Kerwan A, Al-Jabir A, Iosifidis C, Agha R. World Health Organization declares global emergency: A review of the 2019 novel coronavirus (COVID-19). Int J Surg. 2020 Apr;76:71-76. doi: 10.1016/j.ijsu.2020.02.034. Epub 2020 Feb 26. Erratum In: Int J Surg. 2020 May;77:217.</citation>
    <PMID>32112977</PMID>
  </reference>
  <reference>
    <citation>Kannan S, Shaik Syed Ali P, Sheeza A, Hemalatha K. COVID-19 (Novel Coronavirus 2019) - recent trends. Eur Rev Med Pharmacol Sci. 2020 Feb;24(4):2006-2011. doi: 10.26355/eurrev_202002_20378.</citation>
    <PMID>32141569</PMID>
  </reference>
  <reference>
    <citation>Lai CC, Shih TP, Ko WC, Tang HJ, Hsueh PR. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and coronavirus disease-2019 (COVID-19): The epidemic and the challenges. Int J Antimicrob Agents. 2020 Mar;55(3):105924. doi: 10.1016/j.ijantimicag.2020.105924. Epub 2020 Feb 17.</citation>
    <PMID>32081636</PMID>
  </reference>
  <reference>
    <citation>Ahn DG, Shin HJ, Kim MH, Lee S, Kim HS, Myoung J, Kim BT, Kim SJ. Current Status of Epidemiology, Diagnosis, Therapeutics, and Vaccines for Novel Coronavirus Disease 2019 (COVID-19). J Microbiol Biotechnol. 2020 Mar 28;30(3):313-324. doi: 10.4014/jmb.2003.03011.</citation>
    <PMID>32238757</PMID>
  </reference>
  <reference>
    <citation>Gao J, Tian Z, Yang X. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. Biosci Trends. 2020 Mar 16;14(1):72-73. doi: 10.5582/bst.2020.01047. Epub 2020 Feb 19.</citation>
    <PMID>32074550</PMID>
  </reference>
  <reference>
    <citation>Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Tissot Dupont H, Honore S, Colson P, Chabriere E, La Scola B, Rolain JM, Brouqui P, Raoult D. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Jul;56(1):105949. doi: 10.1016/j.ijantimicag.2020.105949. Epub 2020 Mar 20.</citation>
    <PMID>32205204</PMID>
  </reference>
  <reference>
    <citation>Principi N, Esposito S. Chloroquine or hydroxychloroquine for prophylaxis of COVID-19. Lancet Infect Dis. 2020 Oct;20(10):1118. doi: 10.1016/S1473-3099(20)30296-6. Epub 2020 Apr 17. No abstract available.</citation>
    <PMID>32311322</PMID>
  </reference>
  <reference>
    <citation>Rathi S, Ish P, Kalantri A, Kalantri S. Hydroxychloroquine prophylaxis for COVID-19 contacts in India. Lancet Infect Dis. 2020 Oct;20(10):1118-1119. doi: 10.1016/S1473-3099(20)30313-3. Epub 2020 Apr 17. No abstract available.</citation>
    <PMID>32311324</PMID>
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  <reference>
    <citation>Gendrot M, Javelle E, Clerc A, Savini H, Pradines B. Chloroquine as a prophylactic agent against COVID-19? Int J Antimicrob Agents. 2020 Jun;55(6):105980. doi: 10.1016/j.ijantimicag.2020.105980. Epub 2020 Apr 12.</citation>
    <PMID>32294495</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>CMN &quot;20 de Noviembre&quot;</investigator_affiliation>
    <investigator_full_name>Sandra Muñoz López</investigator_full_name>
    <investigator_title>Internal Medicine Service Member, MD, MSc</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Chloroquine phosphate</keyword>
  <keyword>Prophylactic</keyword>
  <keyword>Health Personnel</keyword>
  <keyword>Severe Acute Respiratory Syndrome Coronavirus-2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chloroquine</mesh_term>
    <mesh_term>Chloroquine diphosphate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04443270
org study id: 01
nct id: NCT04443270
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Controlled Clinical Trial
primary purpose: Prevention
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.
measure: Negative Polymerase Chain Reaction assay at day 0
time frame: Day 0
description: 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.
measure: Polymerase Chain Reaction assay at day 60
time frame: Day 60
description: 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.
measure: Clinical improvement related to COVID-19
time frame: Baseline (day 0) and 30-day follow up
description: 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
measure: Clinical improvement related to COVID-19
time frame: From 30-day to 60-day follow-up
description: 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
measure: Heart rhythm negative adverse event related to the Chloroquine Phosphate Prophylactic Use
time frame: Baseline (day 0) and 30-day follow up
description: 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."
measure: Heart rhythm negative adverse event related to the Chloroquine Phosphate Prophylactic
time frame: From 30-day to 60-day follow-up
description: 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."
measure: COVID-19 symptomatic onset rate
time frame: From baseline (day 0) to 60-day follow up
description: 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.
arm group label: Chloroquine phosphate prophylactic group
arm group type: Experimental
description: 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.
arm group label: Control group
arm group type: No Intervention
description: Health personnel who want to be included voluntary in the study and meet the inclusion criteria without Chloroquine use.
intervention type: Drug
intervention name: Chloroquine phosphate
description: 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.
arm group label: Chloroquine phosphate prophylactic group
other name: Plasmodín
criteria: 
gender: All
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sandra Muñoz-López, MD, MSc
role: Principal Investigator
affiliation: CMN "20 de Noviembre"
last name: Sandra Muñoz-López, MD, MSc
role: Study Director
affiliation: CMN "20 de Noviembre"
last name: Maricela Escarela-Serrano, MD
role: Study Chair
affiliation: CMN "20 de Noviembre"
last name: Fedra Irazoque-Palazuelos, MD
role: Study Chair
affiliation: CMN "20 de Noviembre"
last name: Luis Montiel-López, MD, MSc
role: Study Chair
affiliation: CMN "20 de Noviembre"
last name: Paul Mondragón-Terán, PhD
role: Study Chair
affiliation: CMN "20 de Noviembre"
last name: Alberto H De la Vega-Bravo, MD
role: Study Chair
affiliation: CMN "20 de Noviembre"
last name: Juan A Pineda-Juárez, PhD
role: Study Chair
affiliation: CMN "20 de Noviembre"
last name: Juan A Suárez-Cuenca, MD, PhD
role: Study Chair
affiliation: CMN "20 de Noviembre"
last name: Sofía L Alcaraz-Estrada, PhD
role: Study Chair
affiliation: CMN "20 de Noviembre"
last name: Eduardo Soei-Sarmiento, BsC
role: Study Chair
affiliation: CMN "20 de Noviembre"
last name: Maribel Santosbeña-Lagunes, MD
role: Study Chair
affiliation: CMN "20 de Noviembre"
last name: Joel Vargas-Hernández, MD
role: Study Chair
affiliation: CMN "20 de Noviembre"
last name: Carlos A Delgado-Quintana, MD
role: Study Chair
affiliation: CMN "20 de Noviembre"
last name: Alejandro Alanis-Vega, MD
role: Study Chair
affiliation: CMN "20 de Noviembre"
last name: Ricardo P Vázquez-Alvarado, MD
role: Study Chair
affiliation: CMN "20 de Noviembre"
last name: Mireya Rodríguez-Martínez, MD
role: Study Chair
affiliation: CMN "20 de Noviembre"
last name: María C Méndez-Vidrio, MD
role: Study Chair
affiliation: CMN "20 de Noviembre"
last name: Fidel Cerda-Tellez, MD
role: Study Chair
affiliation: CMN "20 de Noviembre"
last name: Sandra Muñoz-López, MD, MSc
phone: +52 55 52 00 5003
phone ext: 14240
email: ssanml@yahoo.com.mx
last name: Juan A Suárez-Cuenca, MD, PhD
phone: +52 55 52 00 5003
phone ext: 14661
email: juan.suarezcue@issste.gob.mx
facility: 
contact: 
contact backup: 
country: Mexico
url: https://www.who.int/emergencies/diseases/novel-coronavirus-2019
description: World Health Organization. Coronavirus disease (COVID-19) outbreak situation.
url: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/events-as-they-happen
description: World Health Organization. Rolling updates on coronavirus disease (COVID-19).
url: https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or
description: 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.
citation: Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020 May;109:102433. doi: 10.1016/j.jaut.2020.102433. Epub 2020 Feb 26.
PMID: 32113704
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PMID: 32183901
citation: Singhal T. A Review of Coronavirus Disease-2019 (COVID-19). Indian J Pediatr. 2020 Apr;87(4):281-286. doi: 10.1007/s12098-020-03263-6. Epub 2020 Mar 13.
PMID: 32166607
citation: Sohrabi C, Alsafi Z, O'Neill N, Khan M, Kerwan A, Al-Jabir A, Iosifidis C, Agha R. World Health Organization declares global emergency: A review of the 2019 novel coronavirus (COVID-19). Int J Surg. 2020 Apr;76:71-76. doi: 10.1016/j.ijsu.2020.02.034. Epub 2020 Feb 26. Erratum In: Int J Surg. 2020 May;77:217.
PMID: 32112977
citation: Kannan S, Shaik Syed Ali P, Sheeza A, Hemalatha K. COVID-19 (Novel Coronavirus 2019) - recent trends. Eur Rev Med Pharmacol Sci. 2020 Feb;24(4):2006-2011. doi: 10.26355/eurrev_202002_20378.
PMID: 32141569
citation: Lai CC, Shih TP, Ko WC, Tang HJ, Hsueh PR. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and coronavirus disease-2019 (COVID-19): The epidemic and the challenges. Int J Antimicrob Agents. 2020 Mar;55(3):105924. doi: 10.1016/j.ijantimicag.2020.105924. Epub 2020 Feb 17.
PMID: 32081636
citation: Ahn DG, Shin HJ, Kim MH, Lee S, Kim HS, Myoung J, Kim BT, Kim SJ. Current Status of Epidemiology, Diagnosis, Therapeutics, and Vaccines for Novel Coronavirus Disease 2019 (COVID-19). J Microbiol Biotechnol. 2020 Mar 28;30(3):313-324. doi: 10.4014/jmb.2003.03011.
PMID: 32238757
citation: Gao J, Tian Z, Yang X. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. Biosci Trends. 2020 Mar 16;14(1):72-73. doi: 10.5582/bst.2020.01047. Epub 2020 Feb 19.
PMID: 32074550
citation: Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Tissot Dupont H, Honore S, Colson P, Chabriere E, La Scola B, Rolain JM, Brouqui P, Raoult D. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Jul;56(1):105949. doi: 10.1016/j.ijantimicag.2020.105949. Epub 2020 Mar 20.
PMID: 32205204
citation: Principi N, Esposito S. Chloroquine or hydroxychloroquine for prophylaxis of COVID-19. Lancet Infect Dis. 2020 Oct;20(10):1118. doi: 10.1016/S1473-3099(20)30296-6. Epub 2020 Apr 17. No abstract available.
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citation: Rathi S, Ish P, Kalantri A, Kalantri S. Hydroxychloroquine prophylaxis for COVID-19 contacts in India. Lancet Infect Dis. 2020 Oct;20(10):1118-1119. doi: 10.1016/S1473-3099(20)30313-3. Epub 2020 Apr 17. No abstract available.
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PMID: 32294495
responsible party type: Principal Investigator
investigator affiliation: CMN "20 de Noviembre"
investigator full name: Sandra Muñoz López
investigator title: Internal Medicine Service Member, MD, MSc
mesh term: COVID-19
mesh term: Chloroquine
mesh term: Chloroquine diphosphate
sharing ipd: No