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

• Sponsor: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado (Other)
• Overall Status: Completed
• CT.gov ID: NCT04399746
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.9
• Patients Per Site Per Month: 10.5

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Relation 3:1 in Combination:Control groupsRelation 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: Mar 15, 2020
• Actual Primary Completion Date: May 20, 2020
• Actual Study Completion Date: Jun 10, 2020

Arms and Interventions

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

Primary Outcome Measures

1. Viral clearance [14 days]

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

Secondary Outcome Measures

1. Symptoms duration [14 days]

   The duration of symptoms in days

2. SpO2 [14 days]

   oxygen saturation

3. SpO2/FiO2 [14 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Outpatient treatment	Mexico City		Mexico	14050

Sponsors and Collaborators

• Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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
• Last Update Posted: Mar 10, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cholecalciferol; Vitamin D; Azithromycin; Ivermectin

Study Results

No Results Posted as of Mar 10, 2022