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

Not Applicable

Completed

• Conditions: COVID
• Interventions: Drug: Ivermectin; Drug: Azithromycin; Drug: Cholecalciferol

• Registration Number: NCT04399746
• Lead Sponsor: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

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.

Study Timeline

• Study Start: 2020-03-15
• Study First Submitted: 2020-05-19
• Primary Completion: 2020-05-20
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-22
• Study Completion: 2020-06-10
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination	Cholecalciferol	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).
Combination	Ivermectin	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).
Combination	Azithromycin	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).

Primary Outcome Measures

Name	Time	Method
Viral clearance	14 days	Test for virus at day 1 and 14 from beginning of trial drug started

Secondary Outcome Measures

Name	Time	Method
Symptoms duration	14 days	The duration of symptoms in days
SpO2/FiO2	14 days	Oxygen Saturation (SpO2)/Fraction of Inspired Oxygen (FiO2) Ratio
SpO2	14 days	oxygen saturation

Trial Locations

Locations (1)

Outpatient treatment; 🇲🇽 Mexico City, Mexico