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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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COVID

Intervention / Treatment
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* Drug: Ivermectin
* Drug: Azithromycin
* Drug: Cholecalciferol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Relation 3:1 in Combination:Control groups
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination<br>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). | Drug: Ivermectin<br>* 6mg once daily in day 0,1,7 and 8<br>Drug: Azithromycin<br>* 500mg once daily for 4 days<br>Drug: Cholecalciferol<br>* 400 IU twice daily for 30 days<br>|
| No Intervention: Control<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral clearance | Test for virus at day 1 and 14 from beginning of trial drug started | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms duration | The duration of symptoms in days | 14 days | 
| SpO2 | oxygen saturation | 14 days | 
| SpO2/FiO2 | Oxygen Saturation (SpO2)/Fraction of Inspired Oxygen (FiO2) Ratio | 14 days |