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Low-dose Hydroxychloroquine and Bromhexine: a Novel Regimen for COVID-19 Prophylaxis in Healthcare Professionals (ELEVATE)

Primary Purpose

Hydroxychloroquine, Antimalarials, Enzyme Inhibitors

Status

Unknown status

Phase

Early Phase 1

Locations

Mexico

Study Type

Interventional

Intervention

Hydroxychloroquine Sulfate

Bromhexine 8 MG

About this trial

This is an interventional prevention trial for Hydroxychloroquine focused on measuring SARS-CoV-2, COVID-19, Hydroxychloroquine, BROMHEXINE

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria

Health personnel working at INR LGII or INCMNSZ who wish to participate in the study and sign the informed consent.
Over 18 and under 60 years of age, both genders.
Contacting with suspected or confirmed SARS-CoV-2 infection.
Normal electrocardiogram.

Exclusion criteria

Positive quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) test for SARS-CoV-2 at the time of inclusion.
Panel of IgG or IgM antibodies positive for SARS-CoV-2 at the time of inclusion.
Development of respiratory symptoms suspicious of SARS-CoV-2 infection during the first 7 days after treatment is initiated, confirmed by qRT-PCR and IgG or IgM antibodies postiver for SARS-CoV-2.
History of allergies to any hydroxychloroquine or bromhexine related compound or medication.
Use of immunosuppressors for any reason.
History of bone marrow transplant.
Known glucose-6-phosphate dehydrogenase deficiency.
Chronic kidney disease or glomerular filtration <20ml/min.
Use of other drugs with reported pharmacological interactions (i.e., digitalis, flecainide, amiodarone, procainamide, or propafenone).
History of long QT syndrome.
Electrocardiogram with QTc>500 msec.
Pregnant or breastfeeding personnel.
Epilepsy.
Known liver disease.
Personnel who have received the Covid-19 vaccine

Elimination criteria

Personnel who decide to leave the study for any reason not related to adverse events.
Personnel with incomplete information on the primary outcome (qRT-PCR for SARS-CoV-2).
Personnel who are relocated to work in another institution.
Personnel who do not wish to participate in the study

Sites / Locations

National Institute of Rehabilitation, Luis Guillermo Ibarra Ibarra

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental: Hydroxychloroquine plus Bromhexine

Hydroxychloroquine plus Bromhexine

Arm Description

200 mg of Hydroxychloroquine daily for 2 months 8 mg of Bromhexine every 8 hrs for 2 months

200 mg of Hydroxycholoroquine daily for 2 months 8 mg of Bromhexine every 8 hrs for 2 months

Outcomes

Primary Outcome Measures

Quantification of the expression of mRNA SARS-CoV-2 and presence or absence of antibodies anti-SARS-CoV-2

Primary endpoint will be the proportion of health personnel infected by SARS-CoV-2 at day 60 after starting treatment, in both groups. The infection will be diagnosed using qRT-PCR for relative expression of the mRNA of SARS-CoV-2 and the measure of IgM and IgG antibodies anti-SARS-CoV-2 after day 7 of treatment using rapid test Cellex qSARS-CoV-2 IgG/IgM

Secondary Outcome Measures

Quantification of the expression of mRNA SARS-CoV-2 and presence or absence of antibodies anti-SARS-CoV-2

The secondary endpoint will be the proportion of health personnel infected 90 days after starting treatment in both groups. The infection will be diagnosed using qRT-PCR for relative expression of the mRNA of SARS-CoV-2 and the measure of IgM and IgG antibodies anti-SARS-CoV-2 after day 7 of the start of treatment using rapid test Cellex qSARS-CoV-2 IgG/IgM

Full Information

NCT ID

NCT04340349

First Posted

April 2, 2020

Last Updated

June 26, 2021

Sponsor

Instituto Nacional de Rehabilitacion

1. Study Identification

Unique Protocol Identification Number

NCT04340349

Brief Title

Low-dose Hydroxychloroquine and Bromhexine: a Novel Regimen for COVID-19 Prophylaxis in Healthcare Professionals

Acronym

ELEVATE

Official Title

Low-dose Hydroxychloroquine and Bromhexine: a Novel Regimen for COVID-19 Prophylaxis in Healthcare Professionals (ELEVATE Trial)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Unknown status

Study Start Date

February 1, 2021 (Actual)

Primary Completion Date

May 30, 2021 (Actual)

Study Completion Date

June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Instituto Nacional de Rehabilitacion

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

This study will investigate the security and efficacy of a daily low dose of hydroxychloroquine and Bromhexine, in preventing the development of the disease from COVID-19 in Health Care Workers at a National Institute of Health In Mexico City.

Detailed Description

This study will combine two drugs (hydroxychloroquine and Bromhexine) to see if hydroxychloroquine is better in combination with Bromhexine in preventing the development of the disease from COVID-19 in Health Care Workers at a National Institute of Health In Mexico City. Hydroxychloroquine will be used in a low dose (200 mg every 24 hrs). Bromhexine will be 8mg every 8 hrs. The study groups will be the following: 1) HCQ 200mg/d + BHH placebo 2) HCQ placebo plus BHH placebo

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hydroxychloroquine, Antimalarials, Enzyme Inhibitors, Antirheumatic Agents

Keywords

SARS-CoV-2, COVID-19, Hydroxychloroquine, BROMHEXINE

7. Study Design

Primary Purpose

Prevention

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Masking Description

DOUBLE BLINDED

Allocation

Randomized

Enrollment

214 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental: Hydroxychloroquine plus Bromhexine

Arm Type

Experimental

Arm Description

200 mg of Hydroxychloroquine daily for 2 months 8 mg of Bromhexine every 8 hrs for 2 months

Arm Title

Hydroxychloroquine plus Bromhexine

Arm Type

Placebo Comparator

Arm Description

200 mg of Hydroxycholoroquine daily for 2 months 8 mg of Bromhexine every 8 hrs for 2 months

Intervention Type

Drug

Intervention Name(s)

Hydroxychloroquine Sulfate

Other Intervention Name(s)

Evoquin

Intervention Description

A daily low dose of Hydroxychloroquine Sulfate. Increase the endosomal pH and inhibits of ACE2 glycosylation receptor.

Intervention Type

Drug

Intervention Name(s)

Bromhexine 8 MG

Other Intervention Name(s)

Bisolvon

Intervention Description

TMPRSS2 blocker

Primary Outcome Measure Information:

Title

Quantification of the expression of mRNA SARS-CoV-2 and presence or absence of antibodies anti-SARS-CoV-2

Description

Time Frame

Day 60

Secondary Outcome Measure Information:

Title

Quantification of the expression of mRNA SARS-CoV-2 and presence or absence of antibodies anti-SARS-CoV-2

Description

Time Frame

Day 90

Other Pre-specified Outcome Measures:

Title

Positive SARS-CoV-2 result during the treatment

Description

The proportion of health personnel positive for SARS-CoV-2 and result in the need for oxygen use, admission to the intensive care unit (ICU), presence of pneumonia by computer tomography scan (CT), death, severe pneumonia defined by the American Thoracic Association, time from hospitalization to recovery in days.

Time Frame

Day 30 and day 90

Title

Adverse events

Description

The proportion of health personnel presenting any of the following during the study period: death, nausea, vomiting, abdominal pain, diarrhea, rash, itchy skin, hair loss, lengthening of the QT interval in the electrocardiogram (>500msec), corneal opacity, cardiac arrhythmias, heart failure or kidney failure (renal clearance <20ml/min). The proportion of the compound of adverse events between the groups will be analyed using RR and ARI for 60 days with their respective 95% confidence intervals

Time Frame

Day 60

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria Health personnel working at INR LGII or INCMNSZ who wish to participate in the study and sign the informed consent. Over 18 and under 60 years of age, both genders. Contacting with suspected or confirmed SARS-CoV-2 infection. Normal electrocardiogram. Exclusion criteria Positive quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) test for SARS-CoV-2 at the time of inclusion. Panel of IgG or IgM antibodies positive for SARS-CoV-2 at the time of inclusion. Development of respiratory symptoms suspicious of SARS-CoV-2 infection during the first 7 days after treatment is initiated, confirmed by qRT-PCR and IgG or IgM antibodies postiver for SARS-CoV-2. History of allergies to any hydroxychloroquine or bromhexine related compound or medication. Use of immunosuppressors for any reason. History of bone marrow transplant. Known glucose-6-phosphate dehydrogenase deficiency. Chronic kidney disease or glomerular filtration <20ml/min. Use of other drugs with reported pharmacological interactions (i.e., digitalis, flecainide, amiodarone, procainamide, or propafenone). History of long QT syndrome. Electrocardiogram with QTc>500 msec. Pregnant or breastfeeding personnel. Epilepsy. Known liver disease. Personnel who have received the Covid-19 vaccine Elimination criteria Personnel who decide to leave the study for any reason not related to adverse events. Personnel with incomplete information on the primary outcome (qRT-PCR for SARS-CoV-2). Personnel who are relocated to work in another institution. Personnel who do not wish to participate in the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julio Granados-Montiel, MD, PhD

Organizational Affiliation

National Institute of Rehabilitation, Mexico

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Institute of Rehabilitation, Luis Guillermo Ibarra Ibarra

City

Mexico City

State/Province

Cdmx

ZIP/Postal Code

14389

Country

Mexico

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Under Mexican Law, we are not able to provide IPD

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Links:

URL

https://covid19.who.int/region/amro/country/mx

Description

Dashboard Mexico 2021

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Low-dose Hydroxychloroquine and Bromhexine: a Novel Regimen for COVID-19 Prophylaxis in Healthcare Professionals

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