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

NCT04340349 | Unknown Early Phase 1

• 1 other identifier: 25/20
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

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 National Institute of Health In Mexico City.

Conditions

Hydroxychloroquine; Antimalarials; Enzyme Inhibitors; Antirheumatic Agents

Keywords

SARS-CoV-2; COVID-19; Hydroxychloroquine; BROMHEXINE

Outcome Measures

Primary Outcomes (1)

• Quantification of the expression of mRNA SARS-CoV-2 and presence or absence of antibodies anti-SARS-CoV-2

  Primary endpoint will be the proportion of health personnel infected by SARS-CoV-2 at day 60 after starting treatment, in both groups. The infection will be diagnosed using qRT-PCR for relative expression of the mRNA of SARS-CoV-2 and the measure of IgM and IgG antibodies anti-SARS-CoV-2 after day 7 of treatment using rapid test Cellex qSARS-CoV-2 IgG/IgM

  Day 60

Secondary Outcomes (1)

• Quantification of the expression of mRNA SARS-CoV-2 and presence or absence of antibodies anti-SARS-CoV-2

  Day 90

Other Outcomes (2)

• Positive SARS-CoV-2 result during the treatment

  Day 30 and day 90

• Adverse events

  Day 60

Study Arms (2)

Experimental: Hydroxychloroquine plus Bromhexine

EXPERIMENTAL

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

Drug: Hydroxychloroquine Sulfate; Drug: Bromhexine 8 MG

Hydroxychloroquine plus Bromhexine

PLACEBO COMPARATOR

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

Drug: Hydroxychloroquine Sulfate; Drug: Bromhexine 8 MG

Interventions

Hydroxychloroquine Sulfate DRUG

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

Also known as: Evoquin

Experimental: Hydroxychloroquine plus Bromhexine; Hydroxychloroquine plus Bromhexine

Bromhexine 8 MG DRUG

TMPRSS2 blocker

Also known as: Bisolvon

Experimental: Hydroxychloroquine plus Bromhexine; Hydroxychloroquine plus Bromhexine

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Rehabilitacion: lead

Study Sites (1)

National Institute of Rehabilitation, Luis Guillermo Ibarra Ibarra

Mexico City, Mexico City, 14389, Mexico

Location

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Related Links

• Dashboard Mexico 2021

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine; Bromhexine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Aniline Compounds; Amines; Organic Chemicals; Cyclohexylamines

Study Officials

• Julio Granados-Montiel, MD, PhD

  Instituto Nacional de Rehabilitacion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: DOUBLE BLINDED
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 9, 2020
• Study Start: February 1, 2021
• Primary Completion: May 30, 2021
• Study Completion: June 30, 2021
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)