Clinical trial NCT04384458: Comparative Study of Hydroxychloroquine and Ivermectin in COVID-19 Prophylaxis
Official title: Comparative Study of Hydroxychloroquine and Ivermectin in COVID-19 Prophylaxis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronavirus Infections
Keywords: Coronavirus Infections
Health Personnel
Hydroxychloroquine
Pre-Exposure Prophylaxis
Antimalarials
Antirheumatic Agents
Ivermectin
Lead sponsor: Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a open-blind, randomised trial.
Primary purpose: PREVENTION

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.

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;

Primary outcomes:
measure: Proportion of participants in whom there was a positivity for SARS-CoV-2.
timeFrame: Post-intervention at day 52
Secondary outcomes:
measure: Participants who developed mild, moderate, or severe forms of COVID-19.
timeFrame: Post-intervention at day 52.
measure: Measurement of the QT interval.
timeFrame: Baseline, 3, 15 and 45 days post-intervention.
measure: Widening of the corrected QT interval or with changes in heart rate on the ECG.
timeFrame: Day 52.
measure: Comparison of hematological and biochemical parameters.
timeFrame: Day 52.
measure: Occurrence of adverse events.
timeFrame: Post-intervention at day 52.
measure: Assessment of COVID-19 symptom severity.
timeFrame: Post-intervention at day 52.
measure: Proportion of participants who discontinue study intervention.
timeFrame: Post-intervention at day 52.
measure: Proportion of participants who required hospital care.
timeFrame: Post-intervention at day 52.
measure: Proportion of participants who required mechanical ventilation.
timeFrame: Post-intervention at day 52.
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Drug Research and Development Center (NPDM), Federal University of Ceará (UFC)
state: Ceará
Study officials:
References: