Ivermectin-Azithromycin-Cholecalciferol (IvAzCol) Combination Therapy for COVID-19 (IvAzCol)
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|ClinicalTrials.gov Identifier: NCT04399746|
Recruitment Status : Recruiting
First Posted : May 22, 2020
Last Update Posted : May 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID||Drug: Ivermectin Drug: Azithromycin Drug: Cholecalciferol||Not Applicable|
The aim of the study is to assess the efficacy of Ivermectin-Azithromycin-Cholecalciferol combination in COVID-19 in early stages of the disease with outpatient management.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Relation 3:1 in Combination:Control groups|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study for COVID-19 Outpatient Treatment With the Combination of Ivermectin-azithromycin-cholecalciferol|
|Actual Study Start Date :||March 15, 2020|
|Actual Primary Completion Date :||May 20, 2020|
|Estimated Study Completion Date :||June 10, 2020|
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).
6mg once daily in day 0,1,7 and 8
500mg once daily for 4 days
400 IU twice daily for 30 days
No Intervention: Control
- Viral clearance [ Time Frame: 14 days ]Test for virus at day 1 and 14 from beginning of trial drug started
- Symptoms duration [ Time Frame: 14 days ]The duration of symptoms in days
- SpO2 [ Time Frame: 14 days ]oxygen saturation
- SpO2/FiO2 [ Time Frame: 14 days ]Oxygen Saturation (SpO2)/Fraction of Inspired Oxygen (FiO2) Ratio
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04399746
|Contact: Guadalupe Espitia, MD, PhD||01 5554471424 ext email@example.com|
|Mexico City, Mexico, 14050|
|Contact: Guadalupe Espitia, MD, PhD 01 5554471424 ext 13272 firstname.lastname@example.org|