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

Covid-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04355026
• Other study ID #: SBCebromhexinCovid-19
• Status: Recruiting
• Phase: Phase 4
• Start date: April 10, 2020
• Est. completion date: July 31, 2020

Study information

• Verified date: April 2020
• Source: General and Teaching Hospital Celje
• Contact: Miha Mežnar
• Phone: +386 3 4233419
• Email: meznar.miha[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid-19
• Pneumonia

Intervention

Drug:
• Bromhexine Oral Tablet and/or hydroxychloroquine tablet
bromhexine 16 mg TID hydroxychloroquine 200 mg BID

Locations

Country	Name	City	State
Slovenia	SB Celje	Celje

Sponsors (1)

Lead Sponsor	Collaborator
General and Teaching Hospital Celje

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of hospitalization	number of days the patient is treated in the hospital	through study completion, an average of 6 months
Primary	Duration of disease	Number of days from the onset of symptoms to hospital discharge	through study completion, an average of 6 months
Secondary	Hospital-aquired pneumonia	Incidence of HAP	through study completion, an average of 6 months
Secondary	ICU stay duration	Number of days spent in the ICU	through study completion, an average of 6 months
Secondary	Oxygene therapy duration	number of days on oxygene therapy	through study completion, an average of 6 months
Secondary	Mechanical ventilatory support duration	Number of hours on mechanical ventilation	through study completion, an average of 6 months