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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 20, 2020

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Combination
    • 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).
  • No Intervention: Control
    • No intervention

Clinical Trial Outcome Measures

Primary Measures

  • Viral clearance
    • Time Frame: 14 days
    • Test for virus at day 1 and 14 from beginning of trial drug started

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
  • Provider of Information About this Clinical Study
    • Principal Investigator: Guadalupe Espitia Hernandez, MD, PhD, Investigator – Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
  • Overall Contact(s)
    • Guadalupe Espitia, MD, PhD, 01 5554471424, lupitaespitia@yahoo.com

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