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

Study Overview
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Brief Summary
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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.

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

Conditions
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Covid-19

Intervention / Treatment
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* Drug: Bromhexine Oral Tablet and/or hydroxychloroquine tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hydroxychloroquine and bromhexine<br>Bromhexine 16 mg TID + hydroxychloroquine 200 mg BID | Drug: Bromhexine Oral Tablet and/or hydroxychloroquine tablet<br>* bromhexine 16 mg TID hydroxychloroquine 200 mg BID<br>* Other names: hydroxychloroquine;|
| Active Comparator: hydroxychloroquine alone<br>hydroxychloroquine 200 mg BID | Drug: Bromhexine Oral Tablet and/or hydroxychloroquine tablet<br>* bromhexine 16 mg TID hydroxychloroquine 200 mg BID<br>* Other names: hydroxychloroquine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospitalization | number of days the patient is treated in the hospital | through study completion, an average of 6 months | 
| Duration of disease | Number of days from the onset of symptoms to hospital discharge | through study completion, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital-aquired pneumonia | Incidence of HAP | through study completion, an average of 6 months | 
| ICU stay duration | Number of days spent in the ICU | through study completion, an average of 6 months | 
| Oxygene therapy duration | number of days on oxygene therapy | through study completion, an average of 6 months | 
| Mechanical ventilatory support duration | Number of hours on mechanical ventilation | through study completion, an average of 6 months |