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Use of Bromhexine and Hydroxychloroquine for Treatment of COVID-19 Pneumonia

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: NCT04355026
Recruitment Status : Unknown
Verified April 2020 by General and Teaching Hospital Celje.
Recruitment status was:  Recruiting
First Posted : April 21, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
General and Teaching Hospital Celje

Study Description
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Brief Summary:

In the current situation it is of great importance to discover a safe, cost-effective and available treatment strategy in order to limit the rapidly spreading SARS-Cov-2. Recent studies have shown that hydroxychloroquine could have a role in the treatment of infected patients. It is however not very likely that hydroxychloroquine alone could be adequate for treatment of Covid-19 disease. Effective therapy that prevents the virus entrance should contain at least TMPRSS2 inhibitor or a competitive inhibitor of viral ACE 2 binding. The use of bromhexine at the dose adequate to selectively inhibit the TMPRSS2, resulting in preventing of viral entrance via TMPRSS2-specific pathway, coud be an effective treatment of Covid-19. In our study we would like to explore the therapeutic potential of bromhexin and hydroxychloroquine in Covid-19 patients.

Hypothesis

  1. Combined treatment with bromhexin and hydroxychloroquine shortens the course of disease in hospitalized Covid-19 patients compared to hydroxychloroquine alone.
  2. Combined treatment with bromhexin and hydroxychloroquine lowers the incidence of secundary pulmonary infections in hospitalized Covid-19 patients compared to hydroxychloroquine alone.
  3. Combined treatment with bromhexin and hydroxychloroquine decreases the need for ICU admission in hospitalized Covid-19 patients compared to hydroxychloroquine alone.

Condition or disease Intervention/treatment Phase
Covid-19 Drug: Bromhexine Oral Tablet and/or hydroxychloroquine tablet Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Bromhexine and Hydroxychloroquine for Treatment of COVID-19 Pneumonia
Estimated Study Start Date : April 10, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: hydroxychloroquine and bromhexine
Bromhexine 16 mg TID + hydroxychloroquine 200 mg BID
 Drug: Bromhexine Oral Tablet and/or hydroxychloroquine tablet
bromhexine 16 mg TID hydroxychloroquine 200 mg BID
Other Name: hydroxychloroquine
Active Comparator: hydroxychloroquine alone
hydroxychloroquine 200 mg BID
 Drug: Bromhexine Oral Tablet and/or hydroxychloroquine tablet
bromhexine 16 mg TID hydroxychloroquine 200 mg BID
Other Name: hydroxychloroquine


Outcome Measures
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Primary Outcome Measures :
  1. Duration of hospitalization [ Time Frame: through study completion, an average of 6 months ]
    number of days the patient is treated in the hospital

  2. Duration of disease [ Time Frame: through study completion, an average of 6 months ]
    Number of days from the onset of symptoms to hospital discharge


Secondary Outcome Measures :
  1. Hospital-aquired pneumonia [ Time Frame: through study completion, an average of 6 months ]
    Incidence of HAP

  2. ICU stay duration [ Time Frame: through study completion, an average of 6 months ]
    Number of days spent in the ICU

  3. Oxygene therapy duration [ Time Frame: through study completion, an average of 6 months ]
    number of days on oxygene therapy

  4. Mechanical ventilatory support duration [ Time Frame: through study completion, an average of 6 months ]
    Number of hours on mechanical ventilation


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 18 years,
  • confirmed infection (positive PCR from nasopharyngeal swab),
  • fullfilled hospital admission criteria

Exclusion Criteria:

  • pregnancy,
  • known allergy for bromhexine or hydroxychloroquine,
  • epilepsy,
  • prolonged QTc interval,
  • Child C liver disease,
  • dementia,
  • psychoorganic syndrome,
  • terminal chronic disease
Contacts and Locations
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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): NCT04355026


Contacts
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Contact: Miha Mežnar +386 3 4233419 meznar.miha@gmail.com
Contact: matej Podbregar +386 3 4233418 matej.podbregar@sb-celje.si

Locations
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Slovenia
SB Celje Recruiting
Celje, Slovenia, 3000
Contact: Miha Mežnar    +386 3 4233419    meznar.miha@gmail.com   
Contact: Matej Podbregar    +386 3 4233419    matej.podbregar@sb-celje.si   
Sponsors and Collaborators
General and Teaching Hospital Celje
More Information
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Responsible Party: General and Teaching Hospital Celje
ClinicalTrials.gov Identifier: NCT04355026    
Other Study ID Numbers: SBCebromhexinCovid-19
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Respiratory Tract Infections
Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
 Hydroxychloroquine
Bromhexine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Expectorants
Respiratory System Agents