Ivermectina Colombia (IVERCOL)

COVID-19 Pneumonia Clinical Trial

— IVERCOL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04886362
• Other study ID #: IVERCOL01
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: July 2021
• Est. completion date: December 2021

Study information

• Verified date: May 2021
• Source: Ayudas Diagnosticas Sura S.A.S
• Contact: Juan Carlos Chacón Jimenez, MD
• Phone: +57 301 5465296
• Email: ceivercol[@]suramericana.com.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 966
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19 Pneumonia
• Pneumonia

Intervention

Drug:
• Ivermectin
Treatment with Ivermectin in the first 7 days from symptoms onset.
• Placebo
Treatment with Placebo in the first 7 days from symptoms onset.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ayudas Diagnosticas Sura S.A.S

Outcome

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