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

NCT ID: NCT04340349

Last Updated: 2021-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-06-30

Brief Summary

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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

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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

Conditions

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Hydroxychloroquine Antimalarials Enzyme Inhibitors Antirheumatic Agents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
DOUBLE BLINDED

Study Groups

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Experimental: Hydroxychloroquine plus Bromhexine

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

Group Type EXPERIMENTAL

Hydroxychloroquine Sulfate

Intervention Type DRUG

A daily low dose of Hydroxychloroquine Sulfate. Increase the endosomal pH and inhibits of ACE2 glycosylation receptor.

Bromhexine 8 MG

Intervention Type DRUG

TMPRSS2 blocker

Hydroxychloroquine plus Bromhexine

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

Group Type PLACEBO_COMPARATOR

Hydroxychloroquine Sulfate

Intervention Type DRUG

A daily low dose of Hydroxychloroquine Sulfate. Increase the endosomal pH and inhibits of ACE2 glycosylation receptor.

Bromhexine 8 MG

Intervention Type DRUG

TMPRSS2 blocker

Interventions

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Hydroxychloroquine Sulfate

A daily low dose of Hydroxychloroquine Sulfate. Increase the endosomal pH and inhibits of ACE2 glycosylation receptor.

Intervention Type DRUG

Bromhexine 8 MG

TMPRSS2 blocker

Intervention Type DRUG

Other Intervention Names

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Evoquin Bisolvon

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Nacional de Rehabilitacion

OTHER_GOV

Sponsor Role lead

Responsible Party

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Julio Granados Montiel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julio Granados-Montiel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Rehabilitacion

Locations

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National Institute of Rehabilitation, Luis Guillermo Ibarra Ibarra

Mexico City, Mexico City, Mexico

Site Status

Countries

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Mexico

References

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Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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Other Identifiers

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25/20

Identifier Type: -

Identifier Source: org_study_id

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