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Completed

NCT Number: NCT04399746

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

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.

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Key information

Conditions

COVID

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient treatment

Mexico City, 14050, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ivermectin

Drug

6mg once daily in day 0,1,7 and 8

Azithromycin

Drug

500mg once daily for 4 days

Cholecalciferol

Drug

400 IU twice daily for 30 days

Primary outcomes

  1. Viral clearance

    Time frame: 14 days

    Test for virus at day 1 and 14 from beginning of trial drug started

Secondary outcomes

  1. Symptoms duration

    Time frame: 14 days

    The duration of symptoms in days

  2. SpO2

    Time frame: 14 days

    oxygen saturation

  3. SpO2/FiO2

    Time frame: 14 days

    Oxygen Saturation (SpO2)/Fraction of Inspired Oxygen (FiO2) Ratio

Sponsors and collaborators

Lead sponsor

Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Other Gov

Registry information

Official study title

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

Acronym: IvAzCol

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 22, 2020
Registry last updated
Mar 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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