Chloroquine Phosphate Prophylactic Use in Health Personnel Exposed to COVID-19 Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04443270 |
Recruitment Status : Unknown
Verified July 2020 by Sandra Muñoz López, CMN "20 de Noviembre".
Recruitment status was: Not yet recruiting
First Posted : June 23, 2020
Last Update Posted : July 14, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 | Drug: Chloroquine phosphate | Phase 1 |
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 |

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.
|
- 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.
- 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.
- 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
- 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
- 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."
- 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."
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 59 Years (Adult) |
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.

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
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 |
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 |
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" |
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: | 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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Chloroquine phosphate Prophylactic Health Personnel Severe Acute Respiratory Syndrome Coronavirus-2 |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases 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 |