Comparative Study of Hydroxychloroquine and Ivermectin in COVID-19 Prophylaxis
1 other identifier
interventional
400
1 country
1
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2020
CompletedFirst Posted
Study publicly available on registry
May 12, 2020
CompletedStudy Start
First participant enrolled
July 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedOctober 6, 2020
October 1, 2020
2 months
May 8, 2020
October 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Post-intervention at day 52
Secondary Outcomes (9)
Participants who developed mild, moderate, or severe forms of COVID-19.
Post-intervention at day 52.
Measurement of the QT interval.
Baseline, 3, 15 and 45 days post-intervention.
Widening of the corrected QT interval or with changes in heart rate on the ECG.
Day 52.
Comparison of hematological and biochemical parameters.
Day 52.
Occurrence of adverse events.
Post-intervention at day 52.
- +4 more secondary outcomes
Study Arms (2)
Hydroxychloroquine
ACTIVE COMPARATOROral 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
Ivermectin
ACTIVE COMPARATOROral 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
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Drug Research and Development Center (NPDM), Federal University of Ceará (UFC)
Fortaleza, Ceará, 60430-275, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
May 8, 2020
First Posted
May 12, 2020
Study Start
July 20, 2020
Primary Completion
September 10, 2020
Study Completion
April 1, 2021
Last Updated
October 6, 2020
Record last verified: 2020-10