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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hydroxychloroquine and bromhexine | Experimental | Bromhexine 16 mg TID + hydroxychloroquine 200 mg BID |
|
| hydroxychloroquine alone | Active Comparator | hydroxychloroquine 200 mg BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bromhexine Oral Tablet and/or hydroxychloroquine tablet | Drug | bromhexine 16 mg TID hydroxychloroquine 200 mg BID |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miha Mežnar | Contact | +386 3 4233419 | meznar.miha@gmail.com | |
| matej Podbregar | Contact | +386 3 4233418 | matej.podbregar@sb-celje.si |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SB Celje | Recruiting | Celje | 3000 | Slovenia |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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|
| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |