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Comparative Study of Hydroxychloroquine and Ivermectin in COVID-19 Prophylaxis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04384458
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
betemora, Universidade Federal do Ceara

Study Description
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Brief Summary:
We have to be aware of the challenge and concerns brought by 2019-nCoV to our healthcare workers. Front-line healthcare workers can become infected in the management of patients with COVID-19; the high viral load in the atmosphere, and infected medical equipment are sources for the spread of SARS-CoV-2. If prevention and control measures are not in place, these healthcare workers are at great risk of infection and become the inadvertent carriers to patients who are in hospital for other diseases. Nowadays a question that has not yet been clarified by science has been arises: is hydroxychloroquine associated with zinc compared to ivermectin associated with zinc effective as a prophylaxis for asymptomatic professionals involved in the treatment of suspected or confirmed case of COVID-19?

Condition or disease Intervention/treatment Phase
Coronavirus Infections Drug: Hydroxychloroquine Drug: Ivermectin Not Applicable

Detailed Description:

The study is a open-blind, randomised trial that will be conducted in asymptomatic professionals working in areas of high exposure and high risk of transmission of SARS-COV-2.

After obtaining fully informed consent, the investigator will recruit workers in areas of high exposure and high risk of transmission of SARS-COV-2.

Participants will be divided into 2 groups:

  • Hydroxychloroquine (HCQ) = 400mg twice on day 1, 400mg/day on day 2, 3, 4, and 5 followed by 400mg once every 05 days, for the next 7 weeks associated with 20 milligrams twice on day of active zinc for 45 consecutive days;
  • Ivermectin (IVM) = Dosage guidelines based on participant body weight, once on day for 2 consecutive days, This dose schedule should be repeated every 14 days for 45 days associated with 20 milligrams twice on day of active zinc.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study is a open-blind, randomised trial.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparative Study of Hydroxychloroquine and Ivermectin in COVID-19 Prophylaxis
Actual Study Start Date : July 20, 2020
Actual Primary Completion Date : September 10, 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Hydroxychloroquine
Oral hydroxychloroquine 400 mg twice a day on day 1, one 400 mg tablet on day 2, 3, 4, and 5, followed by one 400 mg tablets every 05 days until day 50th associated with with 20 milligrams twice on day of active zinc for 45 consecutive days
 Drug: Hydroxychloroquine
Oral hydroxychloroquine 400 mg twice a day on day 1, one 400 mg tablet on day 2, 3, 4, and 5, followed by one 400 mg tablets every 05 days until day 50th associated with 66 mg of zinc sulfate.
Active Comparator: Ivermectin
Oral ivermectin dosage guidelines based on participant body weight, once on day for 2 consecutive days. This dose schedule should be repeated every 14 days for 45 days associated with 20 milligrams twice on day of active zinc.
 Drug: Ivermectin
Oral ivermectin dosage guidelines based on participant body weight, once on day for 2 consecutive days. This dose schedule should be repeated every 14 days for 45 days associated with 20 milligrams twice on day of active zinc.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants in whom there was a positivity for SARS-CoV-2. [ Time Frame: Post-intervention at day 52 ]
    Proportion of participants in whom there was a a positivity for SARS-CoV-2 through specific examination (RT-PCR) or by serology for antibodies specific (IgM and IgG), corroborated or not with clinical finding of COVID-19, defined as the occurrence of signs and symptoms suggestive of this disease.


Secondary Outcome Measures :
  1. Participants who developed mild, moderate, or severe forms of COVID-19. [ Time Frame: Post-intervention at day 52. ]
    Proportion of participants who developed mild, moderate, or severe forms of COVID-19.

  2. Measurement of the QT interval. [ Time Frame: Baseline, 3, 15 and 45 days post-intervention. ]
    Measurement of the QT interval through electrocardiogram evaluation.

  3. Widening of the corrected QT interval or with changes in heart rate on the ECG. [ Time Frame: Day 52. ]
    Proportion of participants who evolved with widening of the corrected QT interval or with changes in heart rate on the ECG.

  4. Comparison of hematological and biochemical parameters. [ Time Frame: Day 52. ]
    Comparison of baseline (visit 0) and final (visit 5) values of hematological and biochemical parameters.

  5. Occurrence of adverse events. [ Time Frame: Post-intervention at day 52. ]
    Proportion of occurrence of adverse events reported by participants or verified by the attending physician, or even observed in laboratory tests.

  6. Assessment of COVID-19 symptom severity. [ Time Frame: Post-intervention at day 52. ]
    Severity of symptoms of COVID-19 measured by a visual analog scale (VAS), with scores ranging from zero to 10, where zero represents the absence of the symptom and 10 corresponds to the most intense manifestation of symptoms (severe dyspnoea).

  7. Proportion of participants who discontinue study intervention. [ Time Frame: Post-intervention at day 52. ]
    Proportion of participants who discontinue study intervention,

  8. Proportion of participants who required hospital care. [ Time Frame: Post-intervention at day 52. ]
    Proportion of participants who required hospital care.

  9. Proportion of participants who required mechanical ventilation. [ Time Frame: Post-intervention at day 52. ]
    Proportion of participants who required mechanical ventilation.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 18 - 70 years;
  • Professionals working in areas of high exposure and high risk of transmission of SARS-COV-2;
  • Understands and agrees to comply with planned study procedures;
  • Signed informed consent for participation in the study.

Exclusion Criteria:

  • Pregnancy or breastfeeding;
  • Major allergy to Hidroxychloroquine, chloroquine or 4-aminoquinolines;
  • Serum potassium lower than 3.4 mEq/l;
  • Serum magnesium lower than 1.7 mg/dL;
  • QTc interval > 470 ms for man and > 480 ms for woman;
  • Weight < 40 kg;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04384458


Contacts
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Contact: Elisabete A Moraes, Professor +5585991219290 betemora@ufc.br

Locations
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Brazil
Drug Research and Development Center (NPDM), Federal University of Ceará (UFC) Recruiting
Fortaleza, Ceará, Brazil, 60430-275
Contact: Elisabete A Moraes, Professor    +5585991219290    betemora@ufc.br   
Contact: A         
Sponsors and Collaborators
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
More Information
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Responsible Party: betemora, MD, PhD, Universidade Federal do Ceara
ClinicalTrials.gov Identifier: NCT04384458    
Other Study ID Numbers: HCQ+IVM
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by betemora, Universidade Federal do Ceara:
Coronavirus Infections
Health Personnel
Hydroxychloroquine
Pre-Exposure Prophylaxis
 Antimalarials
Antirheumatic Agents
Ivermectin
Additional relevant MeSH terms:
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Coronavirus Infections
Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Hydroxychloroquine
Ivermectin
 Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents