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Ivermectin to Prevent Hospitalizations in COVID-19 (IVERCORCOVID19)

Primary Purpose

Covid19

Status
Completed
Phase
Phase 2
Locations
Argentina
Study Type
Interventional
Intervention
Ivermectin
Placebo
Sponsored by
Instituto de Cardiología de Corrientes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Ivermectin

Eligibility Criteria

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

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.

Sites / Locations

  • Ministry of Public Health of the Province of Corrientes

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ivermectin

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Hospitalization of medical cause in patients with COVID-19 in each arm
Hospitalization will be considered when at least 24 hours have elapsed in a health institution, in any of its services.

Secondary Outcome Measures

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

Full Information

First Posted
August 21, 2020
Last Updated
July 4, 2021
Sponsor
Instituto de Cardiología de Corrientes
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1. Study Identification

Unique Protocol Identification Number
NCT04529525
Brief Title
Ivermectin to Prevent Hospitalizations in COVID-19
Acronym
IVERCORCOVID19
Official Title
Ivermectin to Prevent Hospitalizations in COVID-19: Randomized, Double-blind, Placebo-controlled
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 19, 2020 (Actual)
Primary Completion Date
February 22, 2021 (Actual)
Study Completion Date
February 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Cardiología de Corrientes

4. Oversight

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

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Ivermectin

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Ivermectin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ivermectin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Percentage of Hospitalization of medical cause in patients with COVID-19 in each arm
Description
Hospitalization will be considered when at least 24 hours have elapsed in a health institution, in any of its services.
Time Frame
through study completion, an average of 30 days
Secondary Outcome Measure Information:
Title
Time to hospitalization
Description
Number of days elapsed
Time Frame
through study completion, an average of 30 days
Title
Percentage of Use of invasive mechanical ventilation support in each arm
Description
All patients who are connected to invasive mechanical ventilation support
Time Frame
through study completion, an average of 30 days
Title
Time to invasive mechanical ventilation support
Description
Number of days elapsed
Time Frame
through study completion, an average of 30 days
Title
Percentage of dialysis in each arm
Description
All patients who require temporary or permanent renal replacement therapy
Time Frame
through study completion, an average of 30 days
Title
All-cause mortality
Description
Death of the patient, from any cause.
Time Frame
through study completion, an average of 30 days
Title
Negative of the swab at 3±1 days and 12±2 days after entering the study
Description
Negative Nasal Swab Using Polymerase Chain Reaction Technique
Time Frame
At days 3±1 and 12±2
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
Description
According to the adverse events that patients may present.
Time Frame
through study completion, an average of 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Ministry of Public Health of the Province of Corrientes
City
Corrientes
ZIP/Postal Code
3400
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32293834
Citation
Simsek Yavuz S, Unal S. Antiviral treatment of COVID-19. Turk J Med Sci. 2020 Apr 21;50(SI-1):611-619. doi: 10.3906/sag-2004-145.
Results Reference
result
PubMed Identifier
18446504
Citation
Gonzalez Canga A, Sahagun Prieto AM, Diez Liebana MJ, Fernandez Martinez N, Sierra Vega M, Garcia Vieitez JJ. The pharmacokinetics and interactions of ivermectin in humans--a mini-review. AAPS J. 2008;10(1):42-6. doi: 10.1208/s12248-007-9000-9. Epub 2008 Jan 25.
Results Reference
result
PubMed Identifier
26988202
Citation
Gotz V, Magar L, Dornfeld D, Giese S, Pohlmann A, Hoper D, Kong BW, Jans DA, Beer M, Haller O, Schwemmle M. Influenza A viruses escape from MxA restriction at the expense of efficient nuclear vRNP import. Sci Rep. 2016 Mar 18;6:23138. doi: 10.1038/srep23138. Erratum In: Sci Rep. 2016 May 09;6:25428.
Results Reference
result
PubMed Identifier
24161512
Citation
Lundberg L, Pinkham C, Baer A, Amaya M, Narayanan A, Wagstaff KM, Jans DA, Kehn-Hall K. Nuclear import and export inhibitors alter capsid protein distribution in mammalian cells and reduce Venezuelan Equine Encephalitis Virus replication. Antiviral Res. 2013 Dec;100(3):662-72. doi: 10.1016/j.antiviral.2013.10.004. Epub 2013 Oct 22.
Results Reference
result
PubMed Identifier
23769930
Citation
Tay MY, Fraser JE, Chan WK, Moreland NJ, Rathore AP, Wang C, Vasudevan SG, Jans DA. Nuclear localization of dengue virus (DENV) 1-4 non-structural protein 5; protection against all 4 DENV serotypes by the inhibitor Ivermectin. Antiviral Res. 2013 Sep;99(3):301-6. doi: 10.1016/j.antiviral.2013.06.002. Epub 2013 Jun 14.
Results Reference
result
PubMed Identifier
22417684
Citation
Wagstaff KM, Sivakumaran H, Heaton SM, Harrich D, Jans DA. Ivermectin is a specific inhibitor of importin alpha/beta-mediated nuclear import able to inhibit replication of HIV-1 and dengue virus. Biochem J. 2012 May 1;443(3):851-6. doi: 10.1042/BJ20120150.
Results Reference
result
PubMed Identifier
7615630
Citation
Chi NC, Adam EJ, Adam SA. Sequence and characterization of cytoplasmic nuclear protein import factor p97. J Cell Biol. 1995 Jul;130(2):265-74. doi: 10.1083/jcb.130.2.265.
Results Reference
result
PubMed Identifier
8599106
Citation
Gorlich D, Mattaj IW. Nucleocytoplasmic transport. Science. 1996 Mar 15;271(5255):1513-8. doi: 10.1126/science.271.5255.1513.
Results Reference
result
PubMed Identifier
16103202
Citation
Rowland RR, Chauhan V, Fang Y, Pekosz A, Kerrigan M, Burton MD. Intracellular localization of the severe acute respiratory syndrome coronavirus nucleocapsid protein: absence of nucleolar accumulation during infection and after expression as a recombinant protein in vero cells. J Virol. 2005 Sep;79(17):11507-12. doi: 10.1128/JVI.79.17.11507-11512.2005.
Results Reference
result
PubMed Identifier
15992957
Citation
Timani KA, Liao Q, Ye L, Zeng Y, Liu J, Zheng Y, Ye L, Yang X, Lingbao K, Gao J, Zhu Y. Nuclear/nucleolar localization properties of C-terminal nucleocapsid protein of SARS coronavirus. Virus Res. 2005 Dec;114(1-2):23-34. doi: 10.1016/j.virusres.2005.05.007. Epub 2005 Jun 29.
Results Reference
result
PubMed Identifier
32251768
Citation
Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3.
Results Reference
result
PubMed Identifier
34215210
Citation
Vallejos J, Zoni R, Bangher M, Villamandos S, Bobadilla A, Plano F, Campias C, Chaparro Campias E, Medina MF, Achinelli F, Guglielmone HA, Ojeda J, Farizano Salazar D, Andino G, Kawerin P, Dellamea S, Aquino AC, Flores V, Martemucci CN, Martinez SM, Segovia JE, Reynoso PI, Sosa NC, Robledo ME, Guarrochena JM, Vernengo MM, Ruiz Diaz N, Meza E, Aguirre MG. Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19) a randomized, double-blind, placebo-controlled trial. BMC Infect Dis. 2021 Jul 2;21(1):635. doi: 10.1186/s12879-021-06348-5.
Results Reference
derived
PubMed Identifier
33234158
Citation
Vallejos J, Zoni R, Bangher M, Villamandos S, Bobadilla A, Plano F, Campias C, Chaparro Campias E, Achinelli F, Guglielmone HA, Ojeda J, Medina F, Farizano Salazar D, Andino G, Ruiz Diaz NE, Kawerin P, Meza E, Dellamea S, Aquino A, Flores V, Martemucci CN, Vernengo MM, Martinez SM, Segovia JE, Aguirre MG. Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19): a structured summary of a study protocol for a randomized controlled trial. Trials. 2020 Nov 24;21(1):965. doi: 10.1186/s13063-020-04813-1.
Results Reference
derived

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Ivermectin to Prevent Hospitalizations in COVID-19

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