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

Completed
COVID

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

Eligibility Criteria

Inclusion Criteria:

- Confirmed infection of SARS-CoV2 virus

- Mild COVID-19

- Symptoms of respiratory illness

- Cough

- Fever (T >38 °C)

Exclusion Criteria:

- Allergy to any of the drugs treatment

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 90 Years
Countries
Mexico
Locations

Outpatient treatment
Mexico City, Mexico

Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
NCT Number
MeSH Terms
Cholecalciferol
Vitamin D
Azithromycin
Ivermectin