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Low-dose Hydroxychloroquine and Bromhexine: a Novel Regimen for COVID-19 Prophylaxis in Healthcare Professionals | Clinical Trials | Clareo Health

UNKNOWNEARLY_PHASE1

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

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

NCT04340349•Instituto Nacional de Rehabilitacion

View on ClinicalTrials.gov

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

Age

18 - 59 years

Sex

ALL

Healthy Volunteers

Yes

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.
+10 more criteria

Locations (1)

National Institute of Rehabilitation, Luis Guillermo Ibarra Ibarra

Mexico City, Mexico City, Mexico

Key Dates

Start Date

February 1, 2021

Primary Completion Date

May 30, 2021

Completion Date

June 30, 2021

Last Updated

June 29, 2021

Enrollment

214

ESTIMATED participants

Conditions

HydroxychloroquineAntimalarialsEnzyme InhibitorsAntirheumatic Agents

Interventions

Hydroxychloroquine Sulfate

DRUG

Bromhexine 8 MG

DRUG

Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)

NCT06535568

Coronary DiseaseHeart Diseases+23 more

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TERMINATEDPHASE2

Protect: Study With Hydroxychloroquine for Prevention and Early Phase Treatment of Coronavirus Disease (COVID-19)

NCT04363827

COVID19Hydroxychloroquine+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 29, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)

Protect: Study With Hydroxychloroquine for Prevention and Early Phase Treatment of Coronavirus Disease (COVID-19)

The Use of Angiotensin Converting Enzyme Inhibitors and Incident Respiratory Infections, Are They Harmful or Protective?

Prevention of COVID19 Infection in Nursing Homes by Chemoprophylaxis With Hydroxychloroquine (PREVICHARM)

Hydroxychloroquine as Prophylaxis for COVID-19 in Healthcare Workers (HCQPreP)

Development and Validation of "Ready-to-Use" Inhalable Forms of Hydroxychloroquine for Treatment of COVID-19