Comparative Study of Hydroxychloroquine and Ivermectin in COVID-19 Prophylaxis

NCT ID: NCT04384458

Last Updated: 2020-10-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-20
• Study Completion Date: 2021-04-30

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.

Conditions

Coronavirus Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Hydroxychloroquine

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Ivermectin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara

OTHER

Sponsor Role: lead

Responsible Party

betemora

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Fortaleza, Ceará, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Elisabete A Moraes, Professor

Role: CONTACT

betemora@ufc.br

+5585991219290

Facility Contacts

Elisabete A Moraes, Professor

Role: primary

betemora@ufc.br

+5585991219290

A

Role: backup

Other Identifiers

HCQ+IVM

Identifier Type: -

Identifier Source: org_study_id