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

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ClinicalTrials.gov Identifier: NCT04399746
Recruitment Status : Recruiting
First Posted : May 22, 2020
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
Guadalupe Espitia Hernandez, MD, PhD, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID Drug: Ivermectin Drug: Azithromycin Drug: Cholecalciferol Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Relation 3:1 in Combination:Control groups
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study for COVID-19 Outpatient Treatment With the Combination of Ivermectin-azithromycin-cholecalciferol
Actual Study Start Date : March 15, 2020
Actual Primary Completion Date : May 20, 2020
Estimated Study Completion Date : June 10, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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).
 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
No Intervention: Control
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Viral clearance [ Time Frame: 14 days ]
    Test for virus at day 1 and 14 from beginning of trial drug started


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04399746


Contacts
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Contact: Guadalupe Espitia, MD, PhD 01 5554471424 ext 13272 lupitaespitia@yahoo.com

Locations
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Mexico
Outpatient treatment Recruiting
Mexico City, Mexico, 14050
Contact: Guadalupe Espitia, MD, PhD    01 5554471424 ext 13272    lupitaespitia@yahoo.com   
Sponsors and Collaborators
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
More Information
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Responsible Party: Guadalupe Espitia Hernandez, MD, PhD, Investigator, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
ClinicalTrials.gov Identifier: NCT04399746    
Other Study ID Numbers: IvAzCol
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ivermectin
Cholecalciferol
Azithromycin
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
 Nutrients
Growth Substances
Bone Density Conservation Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antiparasitic Agents