Coronavirus InfectionsNCT04384458
Comparative Study of Hydroxychloroquine and Ivermectin in COVID-19 Prophylaxis
A study testing Hydroxychloroquine and Ivermectin in people with Coronavirus Infections, run by Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Infections
- What is being tested?
- Hydroxychloroquine and Ivermectin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jul 2020to Apr 2021
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Drug Research and Development Center (NPDM), Federal University of Ceará (UFC)
Fortaleza, Ceará, 60430-275
Elisabete A Moraes, Professor, +5585991219290, betemora@ufc.br
A
About this study
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?
Read the 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.
- Conditions
- Coronavirus Infections
- Being tested
- Hydroxychloroquine, Ivermectin
- Keywords
- Coronavirus Infections, Health Personnel, Hydroxychloroquine, Pre-Exposure Prophylaxis, Antimalarials, Antirheumatic Agents, Ivermectin
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
IvermectinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine | Active comparator | 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 Receives: Drug: Hydroxychloroquine |
| Ivermectin | Active comparator | 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. Receives: Drug: Ivermectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-intervention at day 52
Secondary outcomes (9)
Participants who developed mild, moderate, or severe forms of COVID-19.
Proportion of participants who developed mild, moderate, or severe forms of COVID-19.
Measured: Post-intervention at day 52.
Measurement of the QT interval.
Measurement of the QT interval through electrocardiogram evaluation.
Measured: Baseline, 3, 15 and 45 days post-intervention.
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.
Measured: Day 52.
Comparison of hematological and biochemical parameters.
Comparison of baseline (visit 0) and final (visit 5) values of hematological and biochemical parameters.
Measured: Day 52.
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.
Measured: Post-intervention at day 52.
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).
Measured: Post-intervention at day 52.
Proportion of participants who discontinue study intervention.
Proportion of participants who discontinue study intervention,
Measured: Post-intervention at day 52.
Proportion of participants who required hospital care.
Proportion of participants who required hospital care.
Measured: Post-intervention at day 52.
Proportion of participants who required mechanical ventilation.
Proportion of participants who required mechanical ventilation.
Measured: Post-intervention at day 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start20 Jul 2020
- Primary completion10 Sep 2020
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a open-blind, randomised trial.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, betemora, Universidade Federal do Ceara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384458
- Sponsor's protocol ID
- HCQ+IVM
- Status last verified
- Oct 2020
- First submitted
- 8 May 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Hydroxychloroquine and Ivermectin in COVID-19 Prophylaxis
- ClinicalTrials.gov ID
- NCT04384458
- Acronym / sponsor ID
- HCQ+IVM
- Conditions
- Coronavirus Infections
- Keywords
- Coronavirus Infections, Health Personnel, Hydroxychloroquine, Pre-Exposure Prophylaxis, Antimalarials, Antirheumatic Agents, Ivermectin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do CearaUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- Apr 2021 (estimated)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a open-blind, randomised trial.
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine | Active comparator | Drug: HydroxychloroquineOral 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 |
| Ivermectin | Active comparator | Drug: IvermectinOral 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroxychloroquineOral 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. | Drug | Hydroxychloroquine |
| IvermectinOral 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 |
Primary outcome
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.
9 secondary outcomes
Participants who developed mild, moderate, or severe forms of COVID-19.
Time frame: Post-intervention at day 52.
Measurement of the QT interval.
Time frame: 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.
Comparison of hematological and biochemical parameters.
Time frame: Day 52.
Occurrence of adverse events.
Time frame: Post-intervention at day 52.
Assessment of COVID-19 symptom severity.
Time frame: Post-intervention at day 52.
Proportion of participants who discontinue study intervention.
Time frame: Post-intervention at day 52.
Proportion of participants who required hospital care.
Time frame: Post-intervention at day 52.
Proportion of participants who required mechanical ventilation.
Time frame: Post-intervention at day 52.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydroxychloroquine and Ivermectin in people with Coronavirus Infections, run by Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara at 1 site in Brazil.
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 6 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 6 Oct 2020. 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 Brazil. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Elisabete A Moraes, Professor (+5585991219290, betemora@ufc.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants in whom there was a positivity for SARS-CoV-2. (time frame: Post-intervention at day 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2020; AzTrials last refreshed its copy on 6 Nov 2026.