Chloroquine Phosphate Prophylactic Use in Health Personnel Exposed to COVID-19 Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Chloroquine Phosphate Prophylactic Use in First-line Health Personnel Exposed to COVID-19 Patients

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Chloroquine phosphate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Controlled Clinical Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chloroquine phosphate prophylactic group<br>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<br>* 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.<br>* Other names: Plasmodín;|
| No Intervention: Control group<br>Health personnel who want to be included voluntary in the study and meet the inclusion criteria without Chloroquine use. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Chloroquine phosphate, Prophylactic, Health Personnel, Severe Acute Respiratory Syndrome Coronavirus-2