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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-10

Study Completion Date

2020-07-31

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

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.

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Detailed Description

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Conditions

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Covid-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hydroxychloroquine and bromhexine

Bromhexine 16 mg TID + hydroxychloroquine 200 mg BID

Group Type EXPERIMENTAL

Bromhexine Oral Tablet and/or hydroxychloroquine tablet

Intervention Type DRUG

bromhexine 16 mg TID hydroxychloroquine 200 mg BID

hydroxychloroquine alone

hydroxychloroquine 200 mg BID

Group Type ACTIVE_COMPARATOR

Bromhexine Oral Tablet and/or hydroxychloroquine tablet

Intervention Type DRUG

bromhexine 16 mg TID hydroxychloroquine 200 mg BID

Interventions

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Bromhexine Oral Tablet and/or hydroxychloroquine tablet

bromhexine 16 mg TID hydroxychloroquine 200 mg BID

Intervention Type DRUG

Other Intervention Names

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hydroxychloroquine

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No