Ivermectina Colombia (IVERCOL)

NCT04886362 | Unknown Phase 2 DMC

• 1 other identifier: IVERCOL01
• Study Type: interventional
• Target: 966
• Locations: 0 countries
• Sites: N/A

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

Keywords

Ivermectin; COVID-19; Ambulatory

Outcome Measures

Primary Outcomes (1)

• 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: 1. Hypoxemia (oxygen saturation ≤90%) and need for supplemental oxygen in home care program; or 2. Need for hospitalization includes general bed, ICU or ICU; or 3. Death from any cause.

  28 days

Secondary Outcomes (9)

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Drug: Ivermectin

Control Group

PLACEBO COMPARATOR

Same volume like ivermectin

Drug: Placebo

Interventions

Ivermectin DRUG

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

Intervention Group

Placebo DRUG

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

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ayudas Diagnosticas Sura S.A.S: lead

MeSH Terms

Conditions

COVID-19

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Juan Carlos Chacón Jimenez, MD

  Emergencies Department Director

  STUDY DIRECTOR

Central Study Contacts

Juan Carlos Chacón Jimenez, MD

CONTACT

+57 301 5465296; ceivercol@suramericana.com.co

Leidy Johana Cañaveral Castañeda

CONTACT

+57 301 2490747; ljcanaveralc@sura.com.co

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 14, 2021
• Study Start: July 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share