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

Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Status: Completed

Conditions: COVID

Treatments: Drug: Ivermectin; Drug: Azithromycin; Drug: Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT04399746

IvAzCol

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Combination

Experimental group

Description:

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).

Treatment:

Drug: Ivermectin

Drug: Azithromycin

Drug: Cholecalciferol

Control

No Intervention group

Description:

No intervention