Clinical trial NCT04886362: Ivermectina Colombia (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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: COVID-19 Pneumonia
Keywords: Ivermectin
COVID-19
Ambulatory
Lead sponsor: Ayudas Diagnosticas Sura S.A.S
Sponsor class: OTHER
First posted: 2021-05-14
Enrollment: 966
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Composite Outcome
timeFrame: 28 days
Secondary outcomes:
measure: Hypoxemia (oxygen saturation ≤90%) and need for supplemental oxygen in home care program.
timeFrame: 28 days
measure: Need for hospitalization including general bed, ICU or ICU.
timeFrame: 28 days
measure: Death from any cause.
timeFrame: 28 days
measure: Proportion of patients with 4 or more points on the WHO scale (8-point ordinal scale).
timeFrame: 28 days
measure: Number of days with supplemental oxygen requirement.
timeFrame: 28 days
measure: Number of days on ICU management.
timeFrame: 28 days
measure: Number of days on endotracheal intubation (IOT).
timeFrame: 28 days
measure: Number of days of hospitalization.
timeFrame: 28 days
measure: Number and type of serious and non-serious adverse events.
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
affiliation: Emergencies Department Director
name: Juan Carlos Chacón Jimenez, MD
role: STUDY_DIRECTOR
References: