COVID-19
Conditions
Keywords
COVID-19, Chloroquine phosphate, Prophylactic, Health Personnel, Severe Acute Respiratory Syndrome Coronavirus-2
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.
Interventions
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.
Sponsors
CMN 20 de Noviembre
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
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.
Intervention model description
Controlled Clinical Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Negative Polymerase Chain Reaction assay at day 0 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical improvement related to COVID-19 | 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 |
| Heart rhythm negative adverse event related to the Chloroquine Phosphate Prophylactic Use | 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 | 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 | 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. |
Countries
Mexico
Contacts
Primary ContactSandra Muñoz-López, MD, MSc
Backup ContactJuan A Suárez-Cuenca, MD, PhD
Outcome results
None listed