Ivermectina Colombia (IVERCOL) (IVERCOL)

Safety and Efficacy and of Ivermectin for the Prevention of Severe Disease in Patients With COVID-19: A Randomized, Controlled, Double-Blind Clinical Study.

A parallel, prospective, double-blind, placebo-controlled clinical trial will be conducted in the population affiliated to EPS SURAMERICANA S.A. with positive test for antigen and PCR for SARS-CoV-2. Participants will be randomly assigned in a 1: 1 ratio to the intervention group or the control group using a sequence of random numbers. The patients included will be those with less than 7 days from the onset of symptoms, and without evidence of serious disease.

One group will be assigned oral ivermectin therapy at a dose of 600 mcg/kg every 12 hours for 5 consecutive days, and the other group will received placebo. A minimum sample size of 483 patients for each arm was calculated to observe differences. All randomized patients will be included in the analysis according to the randomization arm (intention-to-treat analysis).

The primary objective is to evaluate the efficacy of ivermectin in the prevention of severe disease, reduction in the rate of hospitalization, reduction of ICU stay, and mortality. This evaluation will be carried out up to 28 days after the intervention begins. Given the public health emergency, the study is expected to be completed in a period of 6 months from the INVIMA approval.

Study Overview

• Status: Not yet recruiting
• Conditions: COVID-19 Pneumonia
• Intervention / Treatment: Drug: Ivermectin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 966
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Juan Carlos Chacón Jimenez, MD; Phone Number: +57 301 5465296; Email: ceivercol@suramericana.com.co
• Study Contact Backup: Name: Leidy Johana Cañaveral Castañeda; Phone Number: +57 301 2490747; Email: ljcanaveralc@sura.com.co

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age equal to or greater than 18 years.
• Patients with positive antigen test or RT-PCR for SARS-CoV-2.
• Patients with less than 7 days from symptoms onset.
• Patients with indication for outpatient management.
• Patients with mild disease according to the official guide "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 8)": Subjects with mild symptoms, with or without radiological signs of pneumonia, with oxygen saturation>90% . - Able to provided consent to participate.

Exclusion Criteria:

• Patients who at the time of admission require hospitalization and / or supplemental oxygen.
• Known history of allergy to ivermectin.
• Known medical history of liver disease.
• Belong to another clinical trial evaluating the efficacy of an investigational drug against COVID-19.

• The following comorbidities:

  • Immunosuppression or HIV.
  • Acute or chronic kidney failure.
  • Current neoplasia.
• Currently use of warfarin, erdafitinib, or quinidine.
• Have received vaccination for SARS-CoV-2.
• Ivermectin consumption prior to inclusion in the research protocol.
• The patient does not accept the conditions of home care and monitoring.
• The patient desists from participating in the study.
• Women in pregnancy or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention Group; Ivermectin 600 mcg/kg every 12 hours for 5 days.	Drug: Ivermectin; Treatment with Ivermectin in the first 7 days from symptoms onset.
PLACEBO_COMPARATOR: Control Group; Same volume like ivermectin	Drug: Placebo; Treatment with Placebo in the first 7 days from symptoms onset.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Outcome	Proportion of patients progressing to severe COVID-19. Progression to severe disease will be considered when at least one of the following clinical situations occurs (composite outcome) the first thing that occurs in each patient during the 28 days after the intervention begins: Hypoxemia (oxygen saturation ≤90%) and need for supplemental oxygen in home care program; or; Need for hospitalization includes general bed, ICU or ICU; or; Death from any cause.	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Hypoxemia (oxygen saturation ≤90%) and need for supplemental oxygen in home care program.	28 days
Need for hospitalization including general bed, ICU or ICU.	28 days
Death from any cause.	28 days
Proportion of patients with 4 or more points on the WHO scale (8-point ordinal scale).	28 days
Number of days with supplemental oxygen requirement.	28 days
Number of days on ICU management.	28 days
Number of days on endotracheal intubation (IOT).	28 days
Number of days of hospitalization.	28 days
Number and type of serious and non-serious adverse events.	28 days

Collaborators and Investigators

• Sponsor: Ayudas Diagnosticas Sura S.A.S
• Investigators: Study Director: Juan Carlos Chacón Jimenez, MD, Emergencies Department Director

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2021
• Primary Completion (ANTICIPATED): September 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (ACTUAL): May 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 14, 2021
• Last Update Submitted That Met QC Criteria: May 10, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; Ivermectin; Ambulatory
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiparasitic Agents; Ivermectin
• Other Study ID Numbers: IVERCOL01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available on request and the proper approval from ethics committee.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No