Comparative Study of Hydroxychloroquine and Ivermectin in COVID-19 Prophylaxis

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

Status: Unknown

Conditions: Coronavirus Infections

Treatments: Drug: Hydroxychloroquine; Drug: Ivermectin

Study type: Interventional

Funder types: Other

Identifiers

NCT04384458

HCQ+IVM

Details and patient eligibility

About

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?

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Hydroxychloroquine

Active Comparator group

Description:

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

Treatment:

Drug: Hydroxychloroquine

Ivermectin

Active Comparator group

Description:

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.

Treatment:

Drug: Ivermectin