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

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ClinicalTrials.gov Identifier: NCT04340349
Recruitment Status : Enrolling by invitation
First Posted : April 9, 2020
Last Update Posted : April 5, 2021
Sponsor:
Information provided by (Responsible Party):
Julio Granados Montiel, Instituto Nacional de Rehabilitacion

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.

Condition or disease Intervention/treatment Phase
Hydroxychloroquine Antimalarials Enzyme Inhibitors Antirheumatic Agents Drug: Hydroxychloroquine Sulfate Drug: Bromhexine 8 MG Early Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: DOUBLE BLINDED
Primary Purpose: Prevention
Official Title: Low-dose Hydroxychloroquine and Bromhexine: a Novel Regimen for COVID-19 Prophylaxis in Healthcare Professionals (ELEVATE Trial)
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental: Hydroxychloroquine plus Bromhexine
200 mg of Hydroxychloroquine daily for 2 months 8 mg of Bromhexine every 8 hrs for 2 months
Drug: Hydroxychloroquine Sulfate
A daily low dose of Hydroxychloroquine Sulfate. Increase the endosomal pH and inhibits of ACE2 glycosylation receptor.
Other Name: Evoquin

Drug: Bromhexine 8 MG
TMPRSS2 blocker
Other Name: Bisolvon

Placebo Comparator: Hydroxychloroquine plus Bromhexine
200 mg of Hydroxycholoroquine daily for 2 months 8 mg of Bromhexine every 8 hrs for 2 months
Drug: Hydroxychloroquine Sulfate
A daily low dose of Hydroxychloroquine Sulfate. Increase the endosomal pH and inhibits of ACE2 glycosylation receptor.
Other Name: Evoquin

Drug: Bromhexine 8 MG
TMPRSS2 blocker
Other Name: Bisolvon




Primary Outcome Measures :
  1. Quantification of the expression of mRNA SARS-CoV-2 and presence or absence of antibodies anti-SARS-CoV-2 [ Time Frame: Day 60 ]
    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


Secondary Outcome Measures :
  1. Quantification of the expression of mRNA SARS-CoV-2 and presence or absence of antibodies anti-SARS-CoV-2 [ Time Frame: Day 90 ]
    The secondary endpoint will be the proportion of health personnel infected 90 days 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 the start of treatment using rapid test Cellex qSARS-CoV-2 IgG/IgM


Other Outcome Measures:
  1. Positive SARS-CoV-2 result during the treatment [ Time Frame: Day 30 and day 90 ]
    The proportion of health personnel positive for SARS-CoV-2 and result in the need for oxygen use, admission to the intensive care unit (ICU), presence of pneumonia by computer tomography scan (CT), death, severe pneumonia defined by the American Thoracic Association, time from hospitalization to recovery in days.

  2. Adverse events [ Time Frame: Day 60 ]
    The proportion of health personnel presenting any of the following during the study period: death, nausea, vomiting, abdominal pain, diarrhea, rash, itchy skin, hair loss, lengthening of the QT interval in the electrocardiogram (>500msec), corneal opacity, cardiac arrhythmias, heart failure or kidney failure (renal clearance <20ml/min). The proportion of the compound of adverse events between the groups will be analyed using RR and ARI for 60 days with their respective 95% confidence intervals



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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  • Health personnel with comorbidities such as diabetes, hypertension, autoimmune diseases (i.e., porphyria, psoriasis, systemic lupus erythematosus), obesity (defined as body mass index ≥30), cardiovascular diseases, respiratory diseases (such as asthma, chronic bronchitis, idiopathic pulmonary fibrosis).
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04340349


Locations
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Mexico
National Institute of Rehabilitation, Luis Guillermo Ibarra Ibarra
Mexico City, Cdmx, Mexico, 14389
Sponsors and Collaborators
Instituto Nacional de Rehabilitacion
Investigators
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Principal Investigator: Julio Granados-Montiel, MD, PhD National Institute of Rehabilitation, Mexico
  Study Documents (Full-Text)

Documents provided by Julio Granados Montiel, Instituto Nacional de Rehabilitacion:
Informed Consent Form  [PDF] February 1, 2021

Additional Information:
Publications of Results:

Other Publications:

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Responsible Party: Julio Granados Montiel, Principal Investigator, Instituto Nacional de Rehabilitacion
ClinicalTrials.gov Identifier: NCT04340349    
Other Study ID Numbers: 25/20
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Under Mexican Law, we are not able to provide IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Julio Granados Montiel, Instituto Nacional de Rehabilitacion:
SARS-CoV-2
COVID-19
Hydroxychloroquine
BROMHEXINE
Additional relevant MeSH terms:
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Hydroxychloroquine
Bromhexine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Expectorants
Respiratory System Agents