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HydroxychloroquineEarly Phase 1ELEVATENCT04340349

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

A Early Phase 1 study testing Hydroxychloroquine Sulfate and Bromhexine 8 MG in people with Hydroxychloroquine and Antimalarials, run by Instituto Nacional de Rehabilitacion at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 59 yearsHealthy volunteers can take part
What is being tested?
Hydroxychloroquine Sulfate and Bromhexine 8 MG
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
214 participants
Where
1 siteMexico
Study dates
1 Feb 2021to 30 Jun 2021
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • National Institute of Rehabilitation, Luis Guillermo Ibarra Ibarra

    Mexico City, Mexico City, 14389

Other trials in Mexico

About this study

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

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.

Read the 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

Being tested
Hydroxychloroquine Sulfate, Bromhexine 8 MG
Keywords
SARS-CoV-2, COVID-19, Hydroxychloroquine, BROMHEXINE
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hydroxychloroquine SulfateDrug

    Also called Evoquin

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

  • Bromhexine 8 MGDrug

    Also called Bisolvon

    TMPRSS2 blocker

Study groups in NCT04340349
Study groupRoleWhat they receive
Experimental: Hydroxychloroquine plus BromhexineExperimental200 mg of Hydroxychloroquine daily for 2 months 8 mg of Bromhexine every 8 hrs for 2 months
Receives: Drug: Hydroxychloroquine Sulfate; Drug: Bromhexine 8 MG
Hydroxychloroquine plus BromhexinePlacebo comparator200 mg of Hydroxycholoroquine daily for 2 months 8 mg of Bromhexine every 8 hrs for 2 months
Receives: Drug: Hydroxychloroquine Sulfate; Drug: Bromhexine 8 MG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day 60

Secondary outcomes (1)

  1. 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

    Measured: Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2020
  2. Study start1 Feb 2021
  3. Primary completion30 May 2021
  4. Study completion30 Jun 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
214 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04340349
Sponsor's protocol ID
25/20
Acronym
ELEVATE
Status last verified
Jun 2021
First submitted
2 Apr 2020
Last updated
29 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Under Mexican Law, we are not able to provide IPD

Publications

  • Pal M, Berhanu G, Desalegn C, Kandi V. Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2): An Update. Cureus. 2020 Mar 26;12(3):e7423. doi: 10.7759/cureus.7423.

    PubMed 32337143

  • Remuzzi A, Remuzzi G. COVID-19 and Italy: what next? Lancet. 2020 Apr 11;395(10231):1225-1228. doi: 10.1016/S0140-6736(20)30627-9. Epub 2020 Mar 13.

    PubMed 32178769

  • Luzzi GA, Peto TE. Adverse effects of antimalarials. An update. Drug Saf. 1993 Apr;8(4):295-311. doi: 10.2165/00002018-199308040-00004.

    PubMed 8481216

  • Gao J, Tian Z, Yang X. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. Biosci Trends. 2020 Mar 16;14(1):72-73. doi: 10.5582/bst.2020.01047. Epub 2020 Feb 19.

    PubMed 32074550

  • Dutta D, Sharma M, Sharma R. Short-term Hydroxychloroquine in COVID-19 Infection in People With or Without Metabolic Syndrome - Clearing Safety Issues and Good Clinical Practice. Eur Endocrinol. 2020 Oct;16(2):109-112. doi: 10.17925/EE.2020.16.2.109. Epub 2020 Oct 6.

    PubMed 33117441

  • Paiardini M, Muller-Trutwin M. HIV-associated chronic immune activation. Immunol Rev. 2013 Jul;254(1):78-101. doi: 10.1111/imr.12079.

    PubMed 23772616

  • Chang R, Sun WZ. Repositioning chloroquine as antiviral prophylaxis against COVID-19: potential and challenges. Drug Discov Today. 2020 Oct;25(10):1786-1792. doi: 10.1016/j.drudis.2020.06.030. Epub 2020 Jul 3.

    PubMed 32629169

  • Juurlink DN. Safety considerations with chloroquine, hydroxychloroquine and azithromycin in the management of SARS-CoV-2 infection. CMAJ. 2020 Apr 27;192(17):E450-E453. doi: 10.1503/cmaj.200528. Epub 2020 Apr 8. No abstract available.

    PubMed 32269021

  • Zanasi A, Mazzolini M, Kantar A. A reappraisal of the mucoactive activity and clinical efficacy of bromhexine. Multidiscip Respir Med. 2017 Mar 20;12:7. doi: 10.1186/s40248-017-0088-1. eCollection 2017.

    PubMed 28331610

  • Depfenhart M, de Villiers D, Lemperle G, Meyer M, Di Somma S. Potential new treatment strategies for COVID-19: is there a role for bromhexine as add-on therapy? Intern Emerg Med. 2020 Aug;15(5):801-812. doi: 10.1007/s11739-020-02383-3. Epub 2020 May 26.

    PubMed 32458206

  • Ravi N, Cortade DL, Ng E, Wang SX. Diagnostics for SARS-CoV-2 detection: A comprehensive review of the FDA-EUA COVID-19 testing landscape. Biosens Bioelectron. 2020 Oct 1;165:112454. doi: 10.1016/j.bios.2020.112454. Epub 2020 Jul 18.

    PubMed 32729549

  • Lai C, Yu R, Wang M, Xian W, Zhao X, Tang Q, Chen R, Zhou X, Li X, Li Z, Li Z, Deng G, Wang F. Shorter incubation period is associated with severe disease progression in patients with COVID-19. Virulence. 2020 Dec;11(1):1443-1452. doi: 10.1080/21505594.2020.1836894.

    PubMed 33108255

  • Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

    PubMed 32109013

  • Li C, Ji F, Wang L, Wang L, Hao J, Dai M, Liu Y, Pan X, Fu J, Li L, Yang G, Yang J, Yan X, Gu B. Asymptomatic and Human-to-Human Transmission of SARS-CoV-2 in a 2-Family Cluster, Xuzhou, China. Emerg Infect Dis. 2020 Jul;26(7):1626-1628. doi: 10.3201/eid2607.200718. Epub 2020 Jun 21.

    PubMed 32228809

  • Xu H, Zhong L, Deng J, Peng J, Dan H, Zeng X, Li T, Chen Q. High expression of ACE2 receptor of 2019-nCoV on the epithelial cells of oral mucosa. Int J Oral Sci. 2020 Feb 24;12(1):8. doi: 10.1038/s41368-020-0074-x.

    PubMed 32094336

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Hydroxychloroquine Sulfate and Bromhexine 8 MG in people with Hydroxychloroquine and Antimalarials, run by Instituto Nacional de Rehabilitacion at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quantification of the expression of mRNA SARS-CoV-2 and presence or absence of antibodies anti-SARS-CoV-2 (time frame: Day 60). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04340349, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2021.

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