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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04340349
Recruitment Status : Enrolling by invitation
First Posted : April 9, 2020
Last Update Posted : May 13, 2020
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, 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 placebo group will receive only Bromhexine and a sham hydroxychloroquine pill.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 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 : May 11, 2020
Estimated Primary Completion Date : July 20, 2020
Estimated Study Completion Date : August 20, 2020

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
Other Name: Plaquenil

Drug: Bromhexine 8 MG
TMPRSS2 blocker
Other Name: Bisolvon

Placebo Comparator: Bromhexine only
8 mg of Bromhexine every 8 hrs for 2 months
Drug: Bromhexine 8 MG
TMPRSS2 blocker
Other Name: Bisolvon




Primary Outcome Measures :
  1. Polymerase chain reaction assay (PCR) negative at day 0 plus negative serological panel for COVID-19 antibodies at enrolment. [ Time Frame: Day 0 ]
    https://www.who.int/blueprint/priority-diseases/key-action/COVID-19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf, this scale reflects a range from uninfected to dead, where 0 is "no clinical or virological evidence of infection", 1 is "no limitation of activities", 2 is "limitation of activities", 3 is "hospitalized, no oxygen therapy", 4 is "oxygen by mask or nasal prongs", 5 is "non-invasive ventilation or high-flow oxygen", 6 is "intubation and mechanical ventilation", 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".

  2. Polymerase chain reaction assay (PCR) negative at day 30. [ Time Frame: Day 30 ]
    https://www.who.int/blueprint/priority-diseases/key-action/COVID-19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf, this scale reflects a range from uninfected to dead, where 0 is "no clinical or virological evidence of infection", 1 is "no limitation of activities", 2 is "limitation of activities", 3 is "hospitalized, no oxygen therapy", 4 is "oxygen by mask or nasal prongs", 5 is "non-invasive ventilation or high-flow oxygen", 6 is "intubation and mechanical ventilation", 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".

  3. Polymerase chain reaction assay (PCR) negative at day 60. [ Time Frame: Day 60 ]
    https://www.who.int/blueprint/priority-diseases/key-action/COVID-19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf, this scale reflects a range from uninfected to dead, where 0 is "no clinical or virological evidence of infection", 1 is "no limitation of activities", 2 is "limitation of activities", 3 is "hospitalized, no oxygen therapy", 4 is "oxygen by mask or nasal prongs", 5 is "non-invasive ventilation or high-flow oxygen", 6 is "intubation and mechanical ventilation", 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

• Health Care workers with high exposure to COVID-19 patients

Exclusion Criteria:

  • Allergy to hydroxychloroquine or bromhexine
  • History of bone marrow transplant
  • Known G6PD deficiency
  • Chronic hemodialysis or Glomerular Filtration Rate < 20ml/min
  • Psoriasis
  • Porphyria
  • Concomitant use of digitalis, flecainide, amiodarone, procainamide, or propafenone
  • Known history of long QT syndrome
  • Current known QTc>500 msec
  • Pregnant or nursing
  • Severe liver disease
  • Seizure disorder

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
Mexico City, Cdmx, Mexico, 14389
Sponsors and Collaborators
Instituto Nacional de Rehabilitacion
Publications of Results:
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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: May 13, 2020
Last Verified: May 2020
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