Comparative Study of Hydroxychloroquine and Ivermectin in COVID-19 Prophylaxis
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ClinicalTrials.gov Identifier: NCT04384458 |
Recruitment Status :
Recruiting
First Posted : May 12, 2020
Last Update Posted : October 6, 2020
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Condition or disease | Intervention/treatment | Phase |
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Coronavirus Infections | Drug: Hydroxychloroquine Drug: Ivermectin | Not Applicable |
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 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 |

Arm | Intervention/treatment |
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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
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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.
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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. |
- 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.
- 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.
- Measurement of the QT interval. [ Time Frame: Baseline, 3, 15 and 45 days post-intervention. ]Measurement of the QT interval through electrocardiogram evaluation.
- 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.
- 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.
- 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.
- 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).
- Proportion of participants who discontinue study intervention. [ Time Frame: Post-intervention at day 52. ]Proportion of participants who discontinue study intervention,
- Proportion of participants who required hospital care. [ Time Frame: Post-intervention at day 52. ]Proportion of participants who required hospital care.
- Proportion of participants who required mechanical ventilation. [ Time Frame: Post-intervention at day 52. ]Proportion of participants who required mechanical ventilation.

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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 |
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;

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
Contact: Elisabete A Moraes, Professor | +5585991219290 | betemora@ufc.br |
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Coronavirus Infections Health Personnel Hydroxychloroquine Pre-Exposure Prophylaxis |
Antimalarials Antirheumatic Agents Ivermectin |
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 |