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

NCT04355026 | Unknown Phase 4

• 1 other identifier: SBCebromhexinCovid-19
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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. 1.Combined treatment with bromhexin and hydroxychloroquine shortens the course of disease in hospitalized Covid-19 patients compared to hydroxychloroquine alone.
2. 2.Combined treatment with bromhexin and hydroxychloroquine lowers the incidence of secundary pulmonary infections in hospitalized Covid-19 patients compared to hydroxychloroquine alone.
3. 3.Combined treatment with bromhexin and hydroxychloroquine decreases the need for ICU admission in hospitalized Covid-19 patients compared to hydroxychloroquine alone.

Conditions

Covid-19

Outcome Measures

Primary Outcomes (2)

• Duration of hospitalization

  number of days the patient is treated in the hospital

  through study completion, an average of 6 months

• Duration of disease

  Number of days from the onset of symptoms to hospital discharge

  through study completion, an average of 6 months

Secondary Outcomes (4)

• Hospital-aquired pneumonia

  through study completion, an average of 6 months

• ICU stay duration

  through study completion, an average of 6 months

• Oxygene therapy duration

  through study completion, an average of 6 months

• Mechanical ventilatory support duration

  through study completion, an average of 6 months

Study Arms (2)

hydroxychloroquine and bromhexine

EXPERIMENTAL

Bromhexine 16 mg TID + hydroxychloroquine 200 mg BID

Drug: Bromhexine Oral Tablet and/or hydroxychloroquine tablet

hydroxychloroquine alone

ACTIVE COMPARATOR

hydroxychloroquine 200 mg BID

Drug: Bromhexine Oral Tablet and/or hydroxychloroquine tablet

Interventions

Bromhexine Oral Tablet and/or hydroxychloroquine tablet DRUG

bromhexine 16 mg TID hydroxychloroquine 200 mg BID

Also known as: hydroxychloroquine

hydroxychloroquine alone; hydroxychloroquine and bromhexine

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18 years,
• confirmed infection (positive PCR from nasopharyngeal swab),
• fullfilled hospital admission criteria

You may not qualify if:

• pregnancy,
• known allergy for bromhexine or hydroxychloroquine,
• epilepsy,
• prolonged QTc interval,
• Child C liver disease,
• dementia,
• psychoorganic syndrome,
• terminal chronic disease

Sponsors & Collaborators

• General and Teaching Hospital Celje: lead

Study Sites (1)

SB Celje

Celje, 3000, Slovenia

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Miha Mežnar

CONTACT

+386 3 4233419; meznar.miha@gmail.com

matej Podbregar

CONTACT

+386 3 4233418; matej.podbregar@sb-celje.si

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 21, 2020
• Study Start: April 10, 2020
• Primary Completion: June 30, 2020
• Study Completion: July 31, 2020
• Last Updated: April 21, 2020

Record last verified: 2020-04

Locations

SL (1)