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

COVID Clinical Trial

— IvAzCol  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04399746
• Other study ID #: IvAzCol
• Status: Completed
• Phase: N/A
• Start date: March 15, 2020
• Est. completion date: June 10, 2020

Study information

• Verified date: March 2022
• Source: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 10, 2020
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Mexico	Outpatient treatment	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral clearance	Test for virus at day 1 and 14 from beginning of trial drug started	14 days
Secondary	Symptoms duration	The duration of symptoms in days	14 days
Secondary	SpO2	oxygen saturation	14 days
Secondary	SpO2/FiO2	Oxygen Saturation (SpO2)/Fraction of Inspired Oxygen (FiO2) Ratio	14 days