Low-dose Hydroxychloroquine and Bromhexine: a Novel Regimen for COVID-19 Prophylaxis in Healthcare Professionals (ELEVATE)

Instituto Nacional de Rehabilitacion

Status and phase: Unknown; Early Phase 1

Conditions: Hydroxychloroquine; Antimalarials; Enzyme Inhibitors; Antirheumatic Agents

Treatments: Drug: Bromhexine 8 MG; Drug: Hydroxychloroquine Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT04340349

25/20

Details and patient eligibility

About

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.

Full 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

Enrollment: 214 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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214 participants in 2 patient groups, including a placebo group

Experimental: Hydroxychloroquine plus Bromhexine

Experimental group

Description:

200 mg of Hydroxychloroquine daily for 2 months 8 mg of Bromhexine every 8 hrs for 2 months

Treatment:

Drug: Hydroxychloroquine Sulfate

Drug: Bromhexine 8 MG

Hydroxychloroquine plus Bromhexine

Placebo Comparator group

Description:

200 mg of Hydroxycholoroquine daily for 2 months 8 mg of Bromhexine every 8 hrs for 2 months

Treatment:

Drug: Hydroxychloroquine Sulfate

Drug: Bromhexine 8 MG