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

Phase 4

• Conditions: Covid-19
• Interventions: Drug: Bromhexine Oral Tablet and/or hydroxychloroquine tablet

• Registration Number: NCT04355026
• Lead Sponsor: General and Teaching Hospital Celje

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study Start: 2020-04-10
• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-18
• Last Update Submitted: 2020-04-18
• Study First Posted: 2020-04-21
• Last Update Posted: 2020-04-21
• Primary Completion: 2020-06-30
• Study Completion: 2020-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hydroxychloroquine and bromhexine	Bromhexine Oral Tablet and/or hydroxychloroquine tablet	Bromhexine 16 mg TID + hydroxychloroquine 200 mg BID
hydroxychloroquine alone	Bromhexine Oral Tablet and/or hydroxychloroquine tablet	hydroxychloroquine 200 mg BID

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
ICU stay duration	through study completion, an average of 6 months	Number of days spent in the ICU
Hospital-aquired pneumonia	through study completion, an average of 6 months	Incidence of HAP
Mechanical ventilatory support duration	through study completion, an average of 6 months	Number of hours on mechanical ventilation
Oxygene therapy duration	through study completion, an average of 6 months	number of days on oxygene therapy

Trial Locations

Locations (1)

SB Celje; 🇸🇮 Celje, Slovenia