Back to resultsChloroquine Phosphate Prophylactic Use in Health Personnel Exposed to COVID-19 Patients
Primary Purpose
COVID-19
Status
Unknown status
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
Chloroquine phosphate
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring COVID-19, Chloroquine phosphate, Prophylactic, Health Personnel, Severe Acute Respiratory Syndrome Coronavirus-2
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.
Sites / Locations
- Centro Médico Nacional "20 de Noviembre"
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Chloroquine phosphate prophylactic group
Control group
Arm 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.
Health personnel who want to be included voluntary in the study and meet the inclusion criteria without Chloroquine use.
Outcomes
Primary Outcome Measures
Negative Polymerase Chain Reaction assay at 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.
Polymerase Chain Reaction assay at 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
Clinical improvement related to COVID-19
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
Clinical improvement related to COVID-19
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
Heart rhythm negative adverse event related to the Chloroquine Phosphate Prophylactic Use
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."
Heart rhythm negative adverse event related to the Chloroquine Phosphate Prophylactic
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."
COVID-19 symptomatic onset rate
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04443270
Brief Title
Chloroquine Phosphate Prophylactic Use in Health Personnel Exposed to COVID-19 Patients
Official Title
Efficacy of Chloroquine Phosphate Prophylactic Use in First-line Health Personnel Exposed to COVID-19 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 27, 2020 (Anticipated)
Primary Completion Date
October 31, 2020 (Anticipated)
Study Completion Date
January 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CMN "20 de Noviembre"
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Chloroquine phosphate, Prophylactic, Health Personnel, Severe Acute Respiratory Syndrome Coronavirus-2
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Controlled Clinical Trial
Masking
Outcomes Assessor
Masking Description
The Outcome Assessor will be an external member of the Internal Medicine Service, which will be blinded to the intervention.
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chloroquine phosphate prophylactic group
Arm Type
Experimental
Arm 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 Title
Control group
Arm Type
No Intervention
Arm 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(s)
Chloroquine phosphate
Other Intervention Name(s)
Plasmodín
Intervention 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.
Primary Outcome Measure Information:
Title
Negative Polymerase Chain Reaction assay at 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.
Time Frame
Day 0
Title
Polymerase Chain Reaction assay at 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.
Time Frame
Day 60
Secondary Outcome Measure Information:
Title
Clinical improvement related to COVID-19
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
Time Frame
Baseline (day 0) and 30-day follow up
Title
Clinical improvement related to COVID-19
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
Time Frame
From 30-day to 60-day follow-up
Title
Heart rhythm negative adverse event related to the Chloroquine Phosphate Prophylactic Use
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."
Time Frame
Baseline (day 0) and 30-day follow up
Title
Heart rhythm negative adverse event related to the Chloroquine Phosphate Prophylactic
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."
Time Frame
From 30-day to 60-day follow-up
Title
COVID-19 symptomatic onset rate
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.
Time Frame
From baseline (day 0) to 60-day follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Muñoz-López, MD, MSc
Phone
+52 55 52 00 5003
Ext
14240
Email
ssanml@yahoo.com.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Juan A Suárez-Cuenca, MD, PhD
Phone
+52 55 52 00 5003
Ext
14661
Email
juan.suarezcue@issste.gob.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Muñoz-López, MD, MSc
Organizational Affiliation
CMN "20 de Noviembre"
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandra Muñoz-López, MD, MSc
Organizational Affiliation
CMN "20 de Noviembre"
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maricela Escarela-Serrano, MD
Organizational Affiliation
CMN "20 de Noviembre"
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fedra Irazoque-Palazuelos, MD
Organizational Affiliation
CMN "20 de Noviembre"
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Luis Montiel-López, MD, MSc
Organizational Affiliation
CMN "20 de Noviembre"
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Paul Mondragón-Terán, PhD
Organizational Affiliation
CMN "20 de Noviembre"
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alberto H De la Vega-Bravo, MD
Organizational Affiliation
CMN "20 de Noviembre"
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Juan A Pineda-Juárez, PhD
Organizational Affiliation
CMN "20 de Noviembre"
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Juan A Suárez-Cuenca, MD, PhD
Organizational Affiliation
CMN "20 de Noviembre"
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sofía L Alcaraz-Estrada, PhD
Organizational Affiliation
CMN "20 de Noviembre"
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eduardo Soei-Sarmiento, BsC
Organizational Affiliation
CMN "20 de Noviembre"
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maribel Santosbeña-Lagunes, MD
Organizational Affiliation
CMN "20 de Noviembre"
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Joel Vargas-Hernández, MD
Organizational Affiliation
CMN "20 de Noviembre"
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carlos A Delgado-Quintana, MD
Organizational Affiliation
CMN "20 de Noviembre"
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alejandro Alanis-Vega, MD
Organizational Affiliation
CMN "20 de Noviembre"
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ricardo P Vázquez-Alvarado, MD
Organizational Affiliation
CMN "20 de Noviembre"
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mireya Rodríguez-Martínez, MD
Organizational Affiliation
CMN "20 de Noviembre"
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
María C Méndez-Vidrio, MD
Organizational Affiliation
CMN "20 de Noviembre"
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fidel Cerda-Tellez, MD
Organizational Affiliation
CMN "20 de Noviembre"
Official's Role
Study Chair
Facility Information:
Facility Name
Centro Médico Nacional "20 de Noviembre"
City
Mexico City
State/Province
Benito Juárez
ZIP/Postal Code
03229
Country
Mexico
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Muñoz-López, MD, MSc
Phone
+52 55 5200 5003
Ext
14240
Email
ssanml@yahoo.com.mx
First Name & Middle Initial & Last Name & Degree
Juan A Suárez-Cuenca, MD, PhD
Phone
+52 55 5200 5003
Ext
14661
Email
juan.suarezcue@issste.gob.mx
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32113704
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.
Results Reference
background
PubMed Identifier
32183901
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.
Results Reference
background
PubMed Identifier
32166607
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.
Results Reference
background
PubMed Identifier
32112977
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.
Results Reference
background
PubMed Identifier
32141569
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.
Results Reference
background
PubMed Identifier
32081636
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.
Results Reference
background
PubMed Identifier
32238757
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.
Results Reference
background
PubMed Identifier
32074550
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.
Results Reference
background
PubMed Identifier
32205204
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.
Results Reference
background
PubMed Identifier
32311322
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.
Results Reference
background
PubMed Identifier
32311324
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.
Results Reference
background
PubMed Identifier
32294495
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.
Results Reference
background
Links:
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.
Learn more about this trial
Chloroquine Phosphate Prophylactic Use in Health Personnel Exposed to COVID-19 Patients
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