A Phase 1 interventional study of Chloroquine phosphate in COVID-19, sponsored by CMN "20 de Noviembre". Status unknown at 1 site in Mexico. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-14.
Sponsored by CMN "20 de Noviembre" · Phase 1, Interventional, and Prevention
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →CMN "20 de Noviembre" is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
Health personnel who want to be included voluntary in the study and meet the inclusion criteria without Chloroquine use.
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
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.
Time frame: 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.
Time frame: Day 60
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
Time frame: 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
Time frame: 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."
Time frame: 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."
Time frame: 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.
Time frame: From baseline (day 0) to 60-day follow up
Plan to share: No
This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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CMN "20 de Noviembre"