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Ivermectin to Prevent Hospitalizations in COVID-19 (IVERCORCOVID19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04529525
Recruitment Status : Completed
First Posted : August 27, 2020
Last Update Posted : July 7, 2021
Sponsor:
Information provided by (Responsible Party):
Instituto de Cardiología de Corrientes

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Covid19 Drug: Ivermectin Drug: Placebo Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 501 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ivermectin to Prevent Hospitalizations in COVID-19: Randomized, Double-blind, Placebo-controlled
Actual Study Start Date : August 19, 2020
Actual Primary Completion Date : February 22, 2021
Actual Study Completion Date : February 22, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Time to hospitalization [ Time Frame: through study completion, an average of 30 days ]
    Number of days elapsed

  2. 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

  3. Time to invasive mechanical ventilation support [ Time Frame: through study completion, an average of 30 days ]
    Number of days elapsed

  4. 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

  5. All-cause mortality [ Time Frame: through study completion, an average of 30 days ]
    Death of the patient, from any cause.

  6. 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

  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04529525


Locations
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Argentina
Ministry of Public Health of the Province of Corrientes
Corrientes, Argentina, 3400
Sponsors and Collaborators
Instituto de Cardiología de Corrientes
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Instituto de Cardiología de Corrientes
ClinicalTrials.gov Identifier: NCT04529525    
Other Study ID Numbers: IVERCORCOVID19MSPICC
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Instituto de Cardiología de Corrientes:
Ivermectin
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Ivermectin
Antiparasitic Agents
Anti-Infective Agents