Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT04384458
Status:
UNKNOWN
Last Update Posted:
2020-10-06
First Post:
2020-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Study of Hydroxychloroquine and Ivermectin in COVID-19 Prophylaxis
Sponsor:
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
Organization:
Study Overview
Official Title:
Comparative Study of Hydroxychloroquine and Ivermectin in COVID-19 Prophylaxis
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: