Clinical trial NCT04340349: Low-dose Hydroxychloroquine and Bromhexine: a Novel Regimen for COVID-19 Prophylaxis in Healthcare Professionals
Official title: Low-dose Hydroxychloroquine and Bromhexine: a Novel Regimen for COVID-19 Prophylaxis in Healthcare Professionals (ELEVATE Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Hydroxychloroquine
Antimalarials
Enzyme Inhibitors
Antirheumatic Agents
Keywords: SARS-CoV-2
COVID-19
Hydroxychloroquine
BROMHEXINE
Lead sponsor: Instituto Nacional de Rehabilitacion
Sponsor class: OTHER_GOV
First posted: 2020-04-09
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: PREVENTION

Brief summary: This study will investigate the security and efficacy of a daily low dose of hydroxychloroquine and Bromhexine, in preventing the development of the disease from COVID-19 in Health Care Workers at a National Institute of Health In Mexico City.

Detailed description: This study will combine two drugs (hydroxychloroquine and Bromhexine) to see if hydroxychloroquine is better in combination with Bromhexine in preventing the development of the disease from COVID-19 in Health Care Workers at a National Institute of Health In Mexico City. Hydroxychloroquine will be used in a low dose (200 mg every 24 hrs). Bromhexine will be 8mg every 8 hrs. The study groups will be the following: 1) HCQ 200mg/d + BHH placebo 2) HCQ placebo plus BHH placebo

Eligibility criteria: Inclusion criteria

* Health personnel working at INR LGII or INCMNSZ who wish to participate in the study and sign the informed consent.
* Over 18 and under 60 years of age, both genders.
* Contacting with suspected or confirmed SARS-CoV-2 infection.
* Normal electrocardiogram.

Exclusion criteria

* Positive quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) test for SARS-CoV-2 at the time of inclusion.
* Panel of IgG or IgM antibodies positive for SARS-CoV-2 at the time of inclusion.
* Development of respiratory symptoms suspicious of SARS-CoV-2 infection during the first 7 days after treatment is initiated, confirmed by qRT-PCR and IgG or IgM antibodies postiver for SARS-CoV-2.
* History of allergies to any hydroxychloroquine or bromhexine related compound or medication.
* Use of immunosuppressors for any reason.
* History of bone marrow transplant.
* Known glucose-6-phosphate dehydrogenase deficiency.
* Chronic kidney disease or glomerular filtration \<20ml/min.
* Use of other drugs with reported pharmacological interactions (i.e., digitalis, flecainide, amiodarone, procainamide, or propafenone).
* History of long QT syndrome.
* Electrocardiogram with QTc\>500 msec.
* Pregnant or breastfeeding personnel.
* Epilepsy.
* Known liver disease.
* Personnel who have received the Covid-19 vaccine

Elimination criteria

* Personnel who decide to leave the study for any reason not related to adverse events.
* Personnel with incomplete information on the primary outcome (qRT-PCR for SARS-CoV-2).
* Personnel who are relocated to work in another institution.
* Personnel who do not wish to participate in the study

Primary outcomes:
measure: Quantification of the expression of mRNA SARS-CoV-2 and presence or absence of antibodies anti-SARS-CoV-2
timeFrame: Day 60
Secondary outcomes:
measure: Quantification of the expression of mRNA SARS-CoV-2 and presence or absence of antibodies anti-SARS-CoV-2
timeFrame: Day 90
Other outcomes:
measure: Positive SARS-CoV-2 result during the treatment
timeFrame: Day 30 and day 90
measure: Adverse events
timeFrame: Day 60
Locations:
city: Mexico City
country: Mexico
facility: National Institute of Rehabilitation, Luis Guillermo Ibarra Ibarra
state: Cdmx
Study officials:
affiliation: Instituto Nacional de Rehabilitacion
name: Julio Granados-Montiel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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