NCT04399746

Ivermectin-Azithromycin-Cholecalciferol (IvAzCol) Combination Therapy for COVID-19

A Pilot Study for COVID-19 Outpatient Treatment With the Combination of Ivermectin-azithromycin-cholecalciferol

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado · Other Government
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

As the world faces COVID-19, the search for effective treatments against the disease and its complications has turned its gaze to drugs that are classically used in other infectious diseases. Some drugs are being examined for the recent evidence on its effects on viral replication and inflammation, one is Azithromycin, used to treat a wide variety of bacterial infections, Ivermectin, an anti-parasitic drug and the other is Cholecalciferol to increase serum concentration of 25-hydroxyvitamin D.

Detailed description

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.

Conditions

• COVID

Interventions

Type	Name	Description
DRUG	Ivermectin	6mg once daily in day 0,1,7 and 8
DRUG	Azithromycin	500mg once daily for 4 days
DRUG	Cholecalciferol	400 IU twice daily for 30 days

Timeline

• Start date: 2020-03-15
• Primary completion: 2020-05-20
• Completion: 2020-06-10
• First posted: 2020-05-22
• Last updated: 2022-03-10

Locations

1 site across 1 country: Mexico