Ivermectin to Prevent Hospitalizations in COVID-19 (IVERCORCOVID19)

July 4, 2021 updated by: Instituto de Cardiología de Corrientes

Ivermectin to Prevent Hospitalizations in COVID-19: Randomized, Double-blind, Placebo-controlled

It is a single-center, prospective, randomized, double-blind, placebo-controlled study carried out by the Ministry of Public Health of the Province of Corrientes, Argentina, in coordination with the Corrientes Institute of Cardiology "Juana F. Cabral". Patients who meet all the inclusion criteria and none of the exclusion criteria are randomized via the web system to receive placebo or ivermectin. The need for hospitalization in patients with COVID-19 is assessed as the primary end point. As secondary end points are evaluated: time to hospitalization (in days); use of invasive mechanical ventilation; time to invasive mechanical ventilation (in days); dialysis; all-cause mortality; negative of the swab at 3 ± 1 days and 12 ± 2 days after entering the study and ivermectin safety.

Intermediate internal analyzes of study objectives and serious adverse events will be performed, including 125; 250 and 375 patients in order to assess the possible need for early termination of the study. For these intermediate internal analyzes, the Haybittle-Peto rule will be followed, therefore a value of p <0.001 will be considered significant

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be carried out in the province of Corrientes, in the Argentine Republic. All patients must be domiciled in this province. In the province of Corrientes, the care of patients with COVID19 is in charge of a single group of professionals (Crisis Committee) and patients who require hospitalization will be carried out in a single hospital destined for this purpose

Study Type

Interventional

Enrollment (Actual)

501

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Corrientes, Argentina, 3400
        • Ministry of Public Health of the Province of Corrientes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Over 18 years of age who reside in the province of Corrientes at the time of diagnosis;
  • Confirmed diagnosis of COVID-19 by polymerase chain reaction test for detection of SARS-CoV2 in the last 48 hours;
  • In the case of women of childbearing age, they must be using a contraceptive method of proven efficacy and safety (barrier, hormonal or permanent contraceptives) for at least 3 months prior to inclusion in the present study and for the entire period of time for the duration of the study and until at least 30 days after the end of this study. A woman will be considered to have no reproductive capacity if she is postmenopausal (at least 2 years without her menstrual cycles) or if she has undergone surgical sterilization (at least one month before the time of inviting her to participate in this study);
  • Weight at the time of inclusion greater than 48,000 kilograms;
  • That they sign the informed consent for participation in the study.

Exclusion Criteria:

  • Pregnant or breastfeeding women;
  • Known allergy to ivermectin or some of the components of ivermectin tablets or placebo;
  • Current use of home oxygen;
  • That require hospitalization due to COVID-19 at the time of diagnosis or history of hospitalization for COVID-19;
  • Presence of mal-absorptive syndrome;
  • Presence of any other concomitant acute infectious disease;
  • Known history of severe liver disease, for example liver cirrhosis;
  • Need or use of antiviral drugs at the time of admission for another viral pathology other than COVID-19;
  • Need or use of hydroxychloroquine or chloroquine;
  • Use of ivermectin up to 7 days prior to randomization;
  • Patients on dialysis or who have required it in the last 2 months or who plan to do it in the next 2 months;
  • Current participation or in the last 30 days in a research study that has included the administration of a drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ivermectin

The dose of ivermectin in patients who are randomized to the active substance depends on the weight of the patient:

More than 48 kg and less than 80 kg: Two tablets of 6 mg each (12 mg in total) at the time of inclusion and the same dose at 24 hours.

More than 80 kg and less than 110 kg: Three tablets of 6 mg each (18 mg in total) at the time of inclusion and the same dose at 24 hours.

More than 110 Kg: Four tablets of 6 mg each (24 mg in total) at the time of inclusion and the same dose at 24 hours.
Drug: Ivermectin
Patients will receive the tablet from the branch to which they were randomized only at the time of inclusion and 24 hours after the first dose.
Placebo Comparator: Placebo

The dose of placebo in patients who are randomized to the this depends on the weight of the patient:

More than 48 kg and less than 80 kg: Two tablets of 6 mg each (12 mg in total) at the time of inclusion and the same dose at 24 hours.

More than 80 kg and less than 110 kg: Three tablets of 6 mg each (18 mg in total) at the time of inclusion and the same dose at 24 hours.

More than 110 Kg: Four tablets of 6 mg each (24 mg in total) at the time of inclusion and the same dose at 24 hours.
Drug: Placebo
Patients will receive the tablet from the branch to which they were randomized only at the time of inclusion and 24 hours after the first dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Hospitalization of medical cause in patients with COVID-19 in each arm
Time Frame: through study completion, an average of 30 days
Hospitalization will be considered when at least 24 hours have elapsed in a health institution, in any of its services.
through study completion, an average of 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to hospitalization
Time Frame: through study completion, an average of 30 days
Number of days elapsed
through study completion, an average of 30 days
Percentage of Use of invasive mechanical ventilation support in each arm
Time Frame: through study completion, an average of 30 days
All patients who are connected to invasive mechanical ventilation support
through study completion, an average of 30 days
Time to invasive mechanical ventilation support
Time Frame: through study completion, an average of 30 days
Number of days elapsed
through study completion, an average of 30 days
Percentage of dialysis in each arm
Time Frame: through study completion, an average of 30 days
All patients who require temporary or permanent renal replacement therapy
through study completion, an average of 30 days
All-cause mortality
Time Frame: through study completion, an average of 30 days
Death of the patient, from any cause.
through study completion, an average of 30 days
Negative of the swab at 3±1 days and 12±2 days after entering the study
Time Frame: At days 3±1 and 12±2
Negative Nasal Swab Using Polymerase Chain Reaction Technique
At days 3±1 and 12±2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
Time Frame: through study completion, an average of 30 days
According to the adverse events that patients may present.
through study completion, an average of 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Cardiología de Corrientes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2020

Primary Completion (Actual)

February 22, 2021

Study Completion (Actual)

February 22, 2021

Study Registration Dates

First Submitted

August 21, 2020

First Submitted That Met QC Criteria

August 26, 2020

First Posted (Actual)

August 27, 2020

Study Record Updates

Last Update Posted (Actual)

July 7, 2021

Last Update Submitted That Met QC Criteria

July 4, 2021

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVERCORCOVID19MSPICC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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