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Comparative Study of Hydroxychloroquine and Ivermectin in COVID-19 Prophylaxis

Primary Purpose

Coronavirus Infections

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Hydroxychloroquine
Ivermectin
Sponsored by
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronavirus Infections focused on measuring Coronavirus Infections, Health Personnel, Hydroxychloroquine, Pre-Exposure Prophylaxis, Antimalarials, Antirheumatic Agents, Ivermectin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • Drug Research and Development Center (NPDM), Federal University of Ceará (UFC)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Hydroxychloroquine

Ivermectin

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Proportion of participants in whom there was a positivity for SARS-CoV-2.
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

Participants who developed mild, moderate, or severe forms of COVID-19.
Proportion of participants who developed mild, moderate, or severe forms of COVID-19.
Measurement of the QT interval.
Measurement of the QT interval through electrocardiogram evaluation.
Widening of the corrected QT interval or with changes in heart rate on the ECG.
Proportion of participants who evolved with widening of the corrected QT interval or with changes in heart rate on the ECG.
Comparison of hematological and biochemical parameters.
Comparison of baseline (visit 0) and final (visit 5) values of hematological and biochemical parameters.
Occurrence of adverse events.
Proportion of occurrence of adverse events reported by participants or verified by the attending physician, or even observed in laboratory tests.
Assessment of COVID-19 symptom severity.
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).
Proportion of participants who discontinue study intervention.
Proportion of participants who discontinue study intervention,
Proportion of participants who required hospital care.
Proportion of participants who required hospital care.
Proportion of participants who required mechanical ventilation.
Proportion of participants who required mechanical ventilation.

Full Information

First Posted
May 8, 2020
Last Updated
October 5, 2020
Sponsor
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
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1. Study Identification

Unique Protocol Identification Number
NCT04384458
Brief Title
Comparative Study of Hydroxychloroquine and Ivermectin in COVID-19 Prophylaxis
Official Title
Comparative Study of Hydroxychloroquine and Ivermectin in COVID-19 Prophylaxis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
September 10, 2020 (Actual)
Study Completion Date
April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infections
Keywords
Coronavirus Infections, Health Personnel, Hydroxychloroquine, Pre-Exposure Prophylaxis, Antimalarials, Antirheumatic Agents, Ivermectin

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study is a open-blind, randomised trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hydroxychloroquine
Arm Type
Active Comparator
Arm Description
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
Arm Title
Ivermectin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ivermectin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of participants in whom there was a positivity for SARS-CoV-2.
Description
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.
Time Frame
Post-intervention at day 52
Secondary Outcome Measure Information:
Title
Participants who developed mild, moderate, or severe forms of COVID-19.
Description
Proportion of participants who developed mild, moderate, or severe forms of COVID-19.
Time Frame
Post-intervention at day 52.
Title
Measurement of the QT interval.
Description
Measurement of the QT interval through electrocardiogram evaluation.
Time Frame
Baseline, 3, 15 and 45 days post-intervention.
Title
Widening of the corrected QT interval or with changes in heart rate on the ECG.
Description
Proportion of participants who evolved with widening of the corrected QT interval or with changes in heart rate on the ECG.
Time Frame
Day 52.
Title
Comparison of hematological and biochemical parameters.
Description
Comparison of baseline (visit 0) and final (visit 5) values of hematological and biochemical parameters.
Time Frame
Day 52.
Title
Occurrence of adverse events.
Description
Proportion of occurrence of adverse events reported by participants or verified by the attending physician, or even observed in laboratory tests.
Time Frame
Post-intervention at day 52.
Title
Assessment of COVID-19 symptom severity.
Description
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).
Time Frame
Post-intervention at day 52.
Title
Proportion of participants who discontinue study intervention.
Description
Proportion of participants who discontinue study intervention,
Time Frame
Post-intervention at day 52.
Title
Proportion of participants who required hospital care.
Description
Proportion of participants who required hospital care.
Time Frame
Post-intervention at day 52.
Title
Proportion of participants who required mechanical ventilation.
Description
Proportion of participants who required mechanical ventilation.
Time Frame
Post-intervention at day 52.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabete A Moraes, Professor
Phone
+5585991219290
Email
betemora@ufc.br
Facility Information:
Facility Name
Drug Research and Development Center (NPDM), Federal University of Ceará (UFC)
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60430-275
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabete A Moraes, Professor
Phone
+5585991219290
Email
betemora@ufc.br
First Name & Middle Initial & Last Name & Degree
A

12. IPD Sharing Statement

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Comparative Study of Hydroxychloroquine and Ivermectin in COVID-19 Prophylaxis

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