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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control group | No Intervention | Health personnel who want to be included voluntary in the study and meet the inclusion criteria without Chloroquine use. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chloroquine phosphate | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandra Muñoz-López, MD, MSc | Contact | +52 55 52 00 5003 | 14240 | ssanml@yahoo.com.mx |
| Juan A Suárez-Cuenca, MD, PhD | Contact | +52 55 52 00 5003 | 14661 | juan.suarezcue@issste.gob.mx |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Médico Nacional "20 de Noviembre" | Mexico City | Benito Juárez | 03229 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32113704 | Background | 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. | |
| 32183901 | Background | 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. |
| Label | URL |
|---|---|
| World Health Organization. Coronavirus disease (COVID-19) outbreak situation. | View source |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C023676 | chloroquine diphosphate |
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Controlled Clinical Trial
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The Outcome Assessor will be an external member of the Internal Medicine Service, which will be blinded to the intervention.
|
| Baseline (day 0) and 30-day follow up |
| 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 | From 30-day to 60-day follow-up |
| 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." | Baseline (day 0) and 30-day follow up |
| 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." | From 30-day to 60-day follow-up |
| 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. | From baseline (day 0) to 60-day follow up |
| 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 |
| 32166607 | Background | 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. |
| 32112977 | Background | 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. |
| 32141569 | Background | 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. |
| 32081636 | Background | 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. |
| 32238757 | Background | 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. |
| 32074550 | Background | 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. |
| 32205204 | Background | 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. |
| 32311322 | Background | 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. |
| 32311324 | Background | 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. |
| 32294495 | Background | 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. |
| World Health Organization. Rolling updates on coronavirus disease (COVID-19). | View source |
| 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. | View source |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |