NCT04443270

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_1 covid19

Timeline
Completed

Started Jul 2020

Shorter than P25 for phase_1 covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

July 27, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

June 17, 2020

Last Update Submit

July 13, 2020

Conditions

COVID-19

Keywords

COVID-19Chloroquine phosphateProphylacticHealth PersonnelSevere Acute Respiratory Syndrome Coronavirus-2

Outcome Measures

Primary Outcomes (2)

  • 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.

    Day 0

  • 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.

    Day 60

Secondary Outcomes (5)

  • Clinical improvement related to COVID-19

    Baseline (day 0) and 30-day follow up

  • Clinical improvement related to COVID-19

    From 30-day to 60-day follow-up

  • Heart rhythm negative adverse event related to the Chloroquine Phosphate Prophylactic Use

    Baseline (day 0) and 30-day follow up

  • Heart rhythm negative adverse event related to the Chloroquine Phosphate Prophylactic

    From 30-day to 60-day follow-up

  • COVID-19 symptomatic onset rate

    From baseline (day 0) to 60-day follow up

Study Arms (2)

Chloroquine phosphate prophylactic group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Health personnel who want to be included voluntary in the study and meet the inclusion criteria without Chloroquine use.

Interventions

Chloroquine phosphateDRUG

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.

Also known as: Plasmodín
Chloroquine phosphate prophylactic group

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Médico Nacional "20 de Noviembre"

Mexico City, Benito Juárez, 03229, Mexico

Location

Related Publications (12)

  • 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: 32113704BACKGROUND

  • 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.

    PMID: 32183901BACKGROUND

  • 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: 32166607BACKGROUND

  • 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.

    PMID: 32112977BACKGROUND

  • 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: 32141569BACKGROUND

  • 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: 32081636BACKGROUND

  • 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: 32238757BACKGROUND

  • 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: 32074550BACKGROUND

  • 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. RETRACTED: 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: 32205204BACKGROUND

  • 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.

    PMID: 32311322BACKGROUND

  • 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.

    PMID: 32311324BACKGROUND

  • 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.

    PMID: 32294495BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19

Interventions

chloroquine diphosphate

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Sandra Muñoz-López, MD, MSc

    CMN "20 de Noviembre"

    PRINCIPAL INVESTIGATOR

  • Sandra Muñoz-López, MD, MSc

    CMN "20 de Noviembre"

    STUDY DIRECTOR

  • 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 CHAIR

Central Study Contacts

Sandra Muñoz-López, MD, MSc

CONTACT

+52 55 52 00 5003ssanml@yahoo.com.mx

Juan A Suárez-Cuenca, MD, PhD

CONTACT

+52 55 52 00 5003juan.suarezcue@issste.gob.mx

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The Outcome Assessor will be an external member of the Internal Medicine Service, which will be blinded to the intervention.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Controlled Clinical Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Internal Medicine Service Member, MD, MSc

Study Record Dates

First Submitted

June 17, 2020

First Posted

June 23, 2020

Study Start

July 27, 2020

Primary Completion

October 31, 2020

Study Completion

January 31, 2021

Last Updated

July 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)