Status:
UNKNOWN
Low-dose Hydroxychloroquine and Bromhexine: a Novel Regimen for COVID-19 Prophylaxis in Healthcare Professionals
Lead Sponsor:
Instituto Nacional de Rehabilitacion
Conditions:
Hydroxychloroquine
Antimalarials
Eligibility:
All Genders
18-59 years
Phase:
EARLY_PHASE1
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 N...
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 i...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2021
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT04340349
Start Date
February 1 2021
End Date
June 30 2021
Last Update
June 29 2021
Active Locations (1)
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1
National Institute of Rehabilitation, Luis Guillermo Ibarra Ibarra
Mexico City, Mexico City, Mexico, 14389