Covid-19
Conditions
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.
Interventions
DRUGBromhexine Oral Tablet and/or hydroxychloroquine tablet
bromhexine 16 mg TID hydroxychloroquine 200 mg BID
Sponsors
General and Teaching Hospital Celje
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospitalization | through study completion, an average of 6 months | number of days the patient is treated in the hospital |
| Duration of disease | through study completion, an average of 6 months | Number of days from the onset of symptoms to hospital discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital-aquired pneumonia | through study completion, an average of 6 months | Incidence of HAP |
| ICU stay duration | through study completion, an average of 6 months | Number of days spent in the ICU |
| Oxygene therapy duration | through study completion, an average of 6 months | number of days on oxygene therapy |
| Mechanical ventilatory support duration | through study completion, an average of 6 months | Number of hours on mechanical ventilation |
Countries
Slovenia
Contacts
Primary ContactMiha Mežnar
Backup Contactmatej Podbregar
Outcome results
None listed