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

• Status: Enrolling by invitation
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Instituto Nacional de Rehabilitacion
• Treatments: Bromhexine; Hydroxychloroquine

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