- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04384458
Comparative Study of Hydroxychloroquine and Ivermectin in COVID-19 Prophylaxis
October 5, 2020 updated by: betemora, Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
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?
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Elisabete A Moraes, Professor
- Phone Number: +5585991219290
- Email: betemora@ufc.br
Study Locations
-
-
Ceará
-
Fortaleza, Ceará, Brazil, 60430-275
- Recruiting
- Drug Research and Development Center (NPDM), Federal University of Ceará (UFC)
-
Contact:
- A
-
Contact:
- Elisabete A Moraes, Professor
- Phone Number: +5585991219290
- Email: betemora@ufc.br
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Post-intervention at day 52
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Post-intervention at day 52.
|
Measurement of the QT interval.
Time Frame: Baseline, 3, 15 and 45 days post-intervention.
|
Measurement of the QT interval through electrocardiogram evaluation.
|
Baseline, 3, 15 and 45 days post-intervention.
|
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.
|
Day 52.
|
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.
|
Day 52.
|
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.
|
Post-intervention at day 52.
|
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).
|
Post-intervention at day 52.
|
Proportion of participants who discontinue study intervention.
Time Frame: Post-intervention at day 52.
|
Proportion of participants who discontinue study intervention,
|
Post-intervention at day 52.
|
Proportion of participants who required hospital care.
Time Frame: Post-intervention at day 52.
|
Proportion of participants who required hospital care.
|
Post-intervention at day 52.
|
Proportion of participants who required mechanical ventilation.
Time Frame: Post-intervention at day 52.
|
Proportion of participants who required mechanical ventilation.
|
Post-intervention at day 52.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 20, 2020
Primary Completion (Actual)
September 10, 2020
Study Completion (Anticipated)
April 1, 2021
Study Registration Dates
First Submitted
May 8, 2020
First Submitted That Met QC Criteria
May 9, 2020
First Posted (Actual)
May 12, 2020
Study Record Updates
Last Update Posted (Actual)
October 6, 2020
Last Update Submitted That Met QC Criteria
October 5, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Coronavirus Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Ivermectin
- Hydroxychloroquine
Other Study ID Numbers
- HCQ+IVM
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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