New prophylaxis regimen for SARS-CoV-2 infection in health professionals with low doses of hydroxychloroquine and bromhexine: a randomised, double-blind placebo clinical trial (ELEVATE Trial)
Dr Julio Granados-Montiel, Eric Hazan-Lasri, Rafael Franco-Cendejas, Tatiana Chávez-Heres, Phaedra Silva-Bermudez, Rocio Aguilar-Gaytán, Natalia Manzano-León, Karla Méndez-Maldonado, Alejandro Alvarez-Arce, Raigam Jafet Martínez-Portilla
BMJ Open, doi:10.1136/bmjopen-2020-045190
New prophylaxis regimen for SARS-CoV-2 infection in health professionals with low doses of hydroxychloroquine and bromhexine: a randomised, double-blind placebo clinical trial (ELEVATE Trial).
Competing interests None declared. Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research. Patient consent for publication Not required.
Ethics approval The approval of the research ethics committee of the INR-LGII of Mexico has been obtained. Provenance and peer review Not commissioned; externally peer reviewed.
Open access This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http:// creativecommons. org/ licenses/ by-nc/ 4. 0/.
ORCID iD Julio Granados-Montiel http:// orcid. org/ 0000-0002-0611-6421
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'abstract': '<jats:sec><jats:title>Introduction</jats:title><jats:p>SARS-CoV-2 infection in Mexico has '
'caused ~2.7 million confirmed cases; around 20%–25% of health workers will be infected by the '
'virus at their workplace, with approximately 4.4% of mortality. High infectivity of '
'SARS-CoV-2 is related with cell entry mechanism, through the ACE receptor. SARS-CoV-2 '
'requires transmembrane protease serine 2 to cleave its spike glycoprotein and ensure fusion '
'of host cell and virus membrane. We propose studying prophylactic treatment with '
'hydroxychloroquine (HCQ) and bromhexine (BHH), which have been shown to be effective in '
'preventing SARS-CoV-2 infection progression when administered in early stages. The aim of '
'this study is to assess the efficacy of HCQ and BHH as prophylactic treatments for SARS-CoV-2 '
'infection in healthy health workers exposed to the '
'virus.</jats:p></jats:sec><jats:sec><jats:title>Methods and '
'analysis</jats:title><jats:p>Double-blind randomised clinical trial, with parallel allocation '
'at a 1:1 ratio with placebo, of low doses of HCQ plus BHH, for 60 days. Study groups will be '
'defined as follows: (1) HCQ 200 mg/day+BHH 8 mg/8 hours versus (2) HCQ placebo plus BHH '
'placebo. Primary endpoint will be efficacy of both interventions for the prevention of '
'SARS-CoV-2 infection, determined by the risk ratio of infected personnel and the absolute '
'risk. At least a 16% reduction in absolute risk is expected between the intervention and '
'placebo groups; a minimum of 20% infection is expected in the placebo group. The sample size '
'calculation estimated a total of 214 patients assigned: two groups of 107 participants '
'each.</jats:p></jats:sec><jats:sec><jats:title>Ethics and '
'dissemination</jats:title><jats:p>This protocol has been approved by the local Medical Ethics '
'Committee (National Institute of Rehabilitation ‘Luis Guillermo Ibarra Ibarra’, approval '
'number INRLGII/25/20) and by the Federal Commission for Protection against Sanitary Risks '
'(COFEPRIS, approval number 203 300 410A0058/2020). The results of the study will be submitted '
'for publication in peer-reviewed journals and disseminated through '
'conferences.</jats:p></jats:sec><jats:sec><jats:title>Trial registration '
'number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" '
'ext-link-type="clintrialgov" specific-use="clinicaltrial pre-results" '
'xlink:href="NCT04340349">NCT04340349</jats:ext-link>.</jats:p></jats:sec>',
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