Ivermectina Colombia (IVERCOL)

NCT ID: NCT04886362

Last Updated: 2021-05-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 966 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-31
• Study Completion Date: 2021-12-31

Brief Summary

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.

Conditions

COVID-19 Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention Group

Ivermectin 600 mcg/kg every 12 hours for 5 days.

Group Type: EXPERIMENTAL

Ivermectin

Intervention Type: DRUG

Treatment with Ivermectin in the first 7 days from symptoms onset.

Control Group

Same volume like ivermectin

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Treatment with Placebo in the first 7 days from symptoms onset.

Interventions

Ivermectin

Treatment with Ivermectin in the first 7 days from symptoms onset.

Intervention Type: DRUG

Placebo

Treatment with Placebo in the first 7 days from symptoms onset.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ayudas Diagnosticas Sura S.A.S

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan Carlos Chacón Jimenez, MD

Role: STUDY_DIRECTOR

Emergencies Department Director

Central Contacts

Juan Carlos Chacón Jimenez, MD

Role: CONTACT

ceivercol@suramericana.com.co

+57 301 5465296

Leidy Johana Cañaveral Castañeda

Role: CONTACT

ljcanaveralc@sura.com.co

+57 301 2490747

Other Identifiers

IVERCOL01

Identifier Type: -

Identifier Source: org_study_id