An interventional study of Hydroxychloroquine and Ivermectin in Coronavirus Infections, sponsored by Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-06.
Sponsored by Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara · Not applicable, Interventional, and Prevention
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?
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:
928 studies on the registry are indexed under Coronavirus Infections; 49 are open to participants now.
This study's planned enrollment of 400 is above the median of 105 across 540 interventional studies indexed under Coronavirus Infections.
Browse Coronavirus Infections studies →Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: Hydroxychloroquine
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.
Drug: Ivermectin
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.
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.
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.
Time frame: Post-intervention at day 52
Participants who developed mild, moderate, or severe forms of COVID-19.
Proportion of participants who developed mild, moderate, or severe forms of COVID-19.
Time frame: Post-intervention at day 52.
Measurement of the QT interval.
Measurement of the QT interval through electrocardiogram evaluation.
Time frame: Baseline, 3, 15 and 45 days post-intervention.
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.
Time frame: Day 52.
Comparison of hematological and biochemical parameters.
Comparison of baseline (visit 0) and final (visit 5) values of hematological and biochemical parameters.
Time frame: Day 52.
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.
Time frame: Post-intervention at day 52.
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).
Time frame: Post-intervention at day 52.
Proportion of participants who discontinue study intervention.
Proportion of participants who discontinue study intervention,
Time frame: Post-intervention at day 52.
Proportion of participants who required hospital care.
Proportion of participants who required hospital care.
Time frame: Post-intervention at day 52.
Proportion of participants who required mechanical ventilation.
Proportion of participants who required mechanical ventilation.
Time frame: Post-intervention at day 52.
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara