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

General and Teaching Hospital Celje

Status and phase: Unknown; Phase 4

Conditions: Covid-19

Treatments: Drug: Bromhexine Oral Tablet and/or hydroxychloroquine tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04355026

SBCebromhexinCovid-19

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

hydroxychloroquine and bromhexine

Experimental group

Description:

Bromhexine 16 mg TID + hydroxychloroquine 200 mg BID

Treatment:

Drug: Bromhexine Oral Tablet and/or hydroxychloroquine tablet

hydroxychloroquine alone

Active Comparator group

Description:

hydroxychloroquine 200 mg BID

Treatment:

Drug: Bromhexine Oral Tablet and/or hydroxychloroquine tablet