Ivermectina Colombia (IVERCOL)

Ayudas Diagnosticas Sura S.A.S

Status and phase: Unknown; Phase 3; Phase 2

Conditions: COVID-19 Pneumonia

Treatments: Drug: Ivermectin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04886362

IVERCOL01

Details and patient eligibility

About

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.

Enrollment: 966 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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966 participants in 2 patient groups, including a placebo group

Intervention Group

Experimental group

Description:

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

Treatment:

Drug: Ivermectin

Control Group

Placebo Comparator group

Description:

Same volume like ivermectin

Treatment:

Drug: Placebo