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Ivermectina Colombia (IVERCOL) (IVERCOL)

Primary Purpose

COVID-19 Pneumonia

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ivermectin
Placebo
Sponsored by
Ayudas Diagnosticas Sura S.A.S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Pneumonia focused on measuring Ivermectin, COVID-19, Ambulatory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Intervention Group

    Control Group

    Arm Description

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

    Same volume like ivermectin

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    May 10, 2021
    Last Updated
    May 10, 2021
    Sponsor
    Ayudas Diagnosticas Sura S.A.S
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04886362
    Brief Title
    Ivermectina Colombia (IVERCOL)
    Acronym
    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

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2021 (Anticipated)
    Primary Completion Date
    September 2021 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ayudas Diagnosticas Sura S.A.S

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19 Pneumonia
    Keywords
    Ivermectin, COVID-19, Ambulatory

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    966 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    Ivermectin 600 mcg/kg every 12 hours for 5 days.
    Arm Title
    Control Group
    Arm Type
    Placebo Comparator
    Arm Description
    Same volume like ivermectin
    Intervention Type
    Drug
    Intervention Name(s)
    Ivermectin
    Intervention Description
    Treatment with Ivermectin in the first 7 days from symptoms onset.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Treatment with Placebo in the first 7 days from symptoms onset.
    Primary Outcome Measure Information:
    Title
    Composite Outcome
    Description
    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.
    Time Frame
    28 days
    Secondary Outcome Measure Information:
    Title
    Hypoxemia (oxygen saturation ≤90%) and need for supplemental oxygen in home care program.
    Time Frame
    28 days
    Title
    Need for hospitalization including general bed, ICU or ICU.
    Time Frame
    28 days
    Title
    Death from any cause.
    Time Frame
    28 days
    Title
    Proportion of patients with 4 or more points on the WHO scale (8-point ordinal scale).
    Time Frame
    28 days
    Title
    Number of days with supplemental oxygen requirement.
    Time Frame
    28 days
    Title
    Number of days on ICU management.
    Time Frame
    28 days
    Title
    Number of days on endotracheal intubation (IOT).
    Time Frame
    28 days
    Title
    Number of days of hospitalization.
    Time Frame
    28 days
    Title
    Number and type of serious and non-serious adverse events.
    Time Frame
    28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Juan Carlos Chacón Jimenez, MD
    Phone
    +57 301 5465296
    Email
    ceivercol@suramericana.com.co
    First Name & Middle Initial & Last Name or Official Title & Degree
    Leidy Johana Cañaveral Castañeda
    Phone
    +57 301 2490747
    Email
    ljcanaveralc@sura.com.co
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Juan Carlos Chacón Jimenez, MD
    Organizational Affiliation
    Emergencies Department Director
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Data will be available on request and the proper approval from ethics committee.

    Learn more about this trial

    Ivermectina Colombia (IVERCOL)

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