Comparative Study of Hydroxychloroquine and Ivermectin in COVID-19 Prophylaxis

Coronavirus Infections Clinical Trial

Official title:

Comparative Study of Hydroxychloroquine and Ivermectin in COVID-19 Prophylaxis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04384458
• Other study ID #: HCQ+IVM
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2020
• Est. completion date: April 2021

Study information

• Verified date: October 2020
• Source: Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
• Contact: Elisabete A Moraes, Professor
• Phone: +5585991219290
• Email: betemora[@]ufc.br
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 2021
• Est. primary completion date: September 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Coronavirus Infections
• Severe Acute Respiratory Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Drug Research and Development Center (NPDM), Federal University of Ceará (UFC)	Fortaleza	Ceará

Sponsors (1)

Lead Sponsor	Collaborator
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Post-intervention at day 52
Secondary	Participants who developed mild, moderate, or severe forms of COVID-19.	Proportion of participants who developed mild, moderate, or severe forms of COVID-19.	Post-intervention at day 52.
Secondary	Measurement of the QT interval.	Measurement of the QT interval through electrocardiogram evaluation.	Baseline, 3, 15 and 45 days post-intervention.
Secondary	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.	Day 52.
Secondary	Comparison of hematological and biochemical parameters.	Comparison of baseline (visit 0) and final (visit 5) values of hematological and biochemical parameters.	Day 52.
Secondary	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.	Post-intervention at day 52.
Secondary	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).	Post-intervention at day 52.
Secondary	Proportion of participants who discontinue study intervention.	Proportion of participants who discontinue study intervention,	Post-intervention at day 52.
Secondary	Proportion of participants who required hospital care.	Proportion of participants who required hospital care.	Post-intervention at day 52.
Secondary	Proportion of participants who required mechanical ventilation.	Proportion of participants who required mechanical ventilation.	Post-intervention at day 52.