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

Hydroxychloroquine Clinical Trial

— ELEVATE  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04340349
• Other study ID #: 25/20
• Status: Enrolling by invitation
• Phase: Early Phase 1
• Start date: February 1, 2021
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2021
• Source: Instituto Nacional de Rehabilitacion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 214
• Est. completion date: June 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Antimalarials
• Antirheumatic Agents
• Enzyme Inhibitors
• Hydroxychloroquine

Intervention

Drug:
• Hydroxychloroquine Sulfate
A daily low dose of Hydroxychloroquine Sulfate. Increase the endosomal pH and inhibits of ACE2 glycosylation receptor.
• Bromhexine 8 MG
TMPRSS2 blocker

Locations

Country	Name	City	State
Mexico	National Institute of Rehabilitation, Luis Guillermo Ibarra Ibarra	Mexico City	Cdmx

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Rehabilitacion

Country where clinical trial is conducted

Mexico, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Positive SARS-CoV-2 result during the treatment	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.	Day 30 and day 90
Other	Adverse events	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	Day 60
Primary	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	Day 60
Secondary	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	Day 90

External Links

•   Dashboard Mexico 2021