Ivermectin-Azithromycin-Cholecalciferol (IvAzCol) Combination Therapy for COVID-19
NCT ID: NCT04399746
Last Updated: 2022-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2020-03-15
2020-06-10
Brief Summary
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Detailed Description
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Enrollment of subject into the trial shall only occur after providing written permission to voluntarily participate into the study by signing and dating the informed consent form before starting any trial related treatment. 30 cases of COVID-19 will be enrolled into the trial with a 3:1 proportion, divided into two groups. First group with confirmed cases of COVID-19 shall be treated with Ivermectin (6mg once daily in day 0,1,7 and 8) plus Azithromycin (500mg once daily for 4 days) plus Cholecalciferol (400 IU twice daily for 30 days) in an outpatient regimen. The second group with confirmed cases of COVID-19 who refused treatment were shall be allocated as the control group for monitoring.
Test for virus at day 1 and 14 from beginning of trial drug started for the outpatient regimen.
Clinical symptoms, oxygen saturation and oxygenation index will be monitored every day of the trial.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Combination
Ivermectin (6mg once daily in day 0,1,7 and 8) plus Azithromycin (500mg once daily for 4 days) plus Cholecalciferol (400 IU twice daily for 30 days).
Ivermectin
6mg once daily in day 0,1,7 and 8
Azithromycin
500mg once daily for 4 days
Cholecalciferol
400 IU twice daily for 30 days
Control
No intervention
No interventions assigned to this group
Interventions
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Ivermectin
6mg once daily in day 0,1,7 and 8
Azithromycin
500mg once daily for 4 days
Cholecalciferol
400 IU twice daily for 30 days
Eligibility Criteria
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Inclusion Criteria
* Mild COVID-19
* Symptoms of respiratory illness
* Cough
* Fever (T \>38 °C)
Exclusion Criteria
18 Years
90 Years
ALL
No
Sponsors
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Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
OTHER_GOV
Responsible Party
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Guadalupe Espitia Hernandez, MD, PhD
Investigator
Locations
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Outpatient treatment
Mexico City, , Mexico
Countries
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Other Identifiers
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IvAzCol
Identifier Type: -
Identifier Source: org_study_id
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