Use of Bromhexine and Hydroxychloroquine for Treatment of COVID-19 Pneumonia
Primary Purpose
Covid-19
Status
Unknown status
Phase
Phase 4
Locations
Slovenia
Study Type
Interventional
Intervention
Bromhexine Oral Tablet and/or hydroxychloroquine tablet
Sponsored by
About this trial
This is an interventional treatment trial for Covid-19
Eligibility 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
Sites / Locations
- SB CeljeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
hydroxychloroquine and bromhexine
hydroxychloroquine alone
Arm Description
Bromhexine 16 mg TID + hydroxychloroquine 200 mg BID
hydroxychloroquine 200 mg BID
Outcomes
Primary Outcome Measures
Duration of hospitalization
number of days the patient is treated in the hospital
Duration of disease
Number of days from the onset of symptoms to hospital discharge
Secondary Outcome Measures
Hospital-aquired pneumonia
Incidence of HAP
ICU stay duration
Number of days spent in the ICU
Oxygene therapy duration
number of days on oxygene therapy
Mechanical ventilatory support duration
Number of hours on mechanical ventilation
Full Information
NCT ID
NCT04355026
First Posted
April 15, 2020
Last Updated
April 18, 2020
Sponsor
General and Teaching Hospital Celje
1. Study Identification
Unique Protocol Identification Number
NCT04355026
Brief Title
Use of Bromhexine and Hydroxychloroquine for Treatment of COVID-19 Pneumonia
Official Title
Use of Bromhexine and Hydroxychloroquine for Treatment of COVID-19 Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 10, 2020 (Anticipated)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
July 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
General and Teaching Hospital Celje
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
Combined treatment with bromhexin and hydroxychloroquine shortens the course of disease in hospitalized Covid-19 patients compared to hydroxychloroquine alone.
Combined treatment with bromhexin and hydroxychloroquine lowers the incidence of secundary pulmonary infections in hospitalized Covid-19 patients compared to hydroxychloroquine alone.
Combined treatment with bromhexin and hydroxychloroquine decreases the need for ICU admission in hospitalized Covid-19 patients compared to hydroxychloroquine alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hydroxychloroquine and bromhexine
Arm Type
Experimental
Arm Description
Bromhexine 16 mg TID + hydroxychloroquine 200 mg BID
Arm Title
hydroxychloroquine alone
Arm Type
Active Comparator
Arm Description
hydroxychloroquine 200 mg BID
Intervention Type
Drug
Intervention Name(s)
Bromhexine Oral Tablet and/or hydroxychloroquine tablet
Other Intervention Name(s)
hydroxychloroquine
Intervention Description
bromhexine 16 mg TID hydroxychloroquine 200 mg BID
Primary Outcome Measure Information:
Title
Duration of hospitalization
Description
number of days the patient is treated in the hospital
Time Frame
through study completion, an average of 6 months
Title
Duration of disease
Description
Number of days from the onset of symptoms to hospital discharge
Time Frame
through study completion, an average of 6 months
Secondary Outcome Measure Information:
Title
Hospital-aquired pneumonia
Description
Incidence of HAP
Time Frame
through study completion, an average of 6 months
Title
ICU stay duration
Description
Number of days spent in the ICU
Time Frame
through study completion, an average of 6 months
Title
Oxygene therapy duration
Description
number of days on oxygene therapy
Time Frame
through study completion, an average of 6 months
Title
Mechanical ventilatory support duration
Description
Number of hours on mechanical ventilation
Time Frame
through study completion, an average of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miha Mežnar
Phone
+386 3 4233419
Email
meznar.miha@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
matej Podbregar
Phone
+386 3 4233418
Email
matej.podbregar@sb-celje.si
Facility Information:
Facility Name
SB Celje
City
Celje
ZIP/Postal Code
3000
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miha Mežnar
Phone
+386 3 4233419
Email
meznar.miha@gmail.com
First Name & Middle Initial & Last Name & Degree
Matej Podbregar
Phone
+386 3 4233419
Email
matej.podbregar@sb-celje.si
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Use of Bromhexine and Hydroxychloroquine for Treatment of COVID-19 Pneumonia
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