IVERCoV: Evaluation of the Impact of the Administration of Single Dose of Ivermectin in the Early Phase of COVID-19

Sponsor
Raincy Montfermeil Hospital Group (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05040724
Collaborator
(none)
200
1
2
12.1
16.5

Study Details

Study Description

Brief Summary

The action of ivermectin in vitro on the viral replication of SARS-CoV-2 was demonstrated and published by an Australian team in June 2020. On the other hand, the doses to be administered in vivo to reach the concentrations described in vitro would lead to toxicities especially neurological, in treated patients, . However, some trials and studies, such as the ICON3 study, demonstrate the clinical efficacy of ivermectin administered at lower doses (200 µg / kg) in hospitalized patients with COVID-19.

The use of ivermectin in the early stages of the disease has not yet been studied. The administration of the maximum authorized dose (MA) of ivermectin could at least slow down the replication of the virus in vivo before the inflammatory phase of COVID-19, and reduce the duration of symptoms as well as the risk of hospitalization of patients, especially in critical care.

Unlike other studies conducted so far on COVID-19, IVERCoV will target the "viral" phase of the disease by screening patients in the city. In addition, home visits (symptom recording +/- PCR) will make it easier to monitor patients during the study.

Detailed Description

The action of ivermectin in vitro on viral replication of SARS-CoV-2 was demonstrated and published by an Australian team in June 2020. On the other hand, the doses to be administered in vivo making it possible to reach the concentrations described in vitro would result in toxicities in treated patients, especially neurological. However, some trials and studies, such as the ICON3 study, demonstrate the clinical efficacy of ivermectin administered at lower doses (200 µg / kg) in hospitalized patients with COVID-19.

The use of ivermectin in the early stages of the disease has not yet been studied. The administration of the maximum authorized dose (MA) of ivermectin could at least slow down the replication of the virus in vivo before the inflammatory phase of COVID-19, and reduce the duration of symptoms as well as the risk of hospitalization of patients, especially in critical care.

Unlike other studies conducted so far on COVID-19, IVERCoV will target the "viral" phase of the disease by screening patients in the city. In addition, home visits (symptom recording +/- PCR) will make it easier to monitor patients during the study.

Prospective, multicenter, double-blind, randomized trial in two parallel groups:
  • a control group: with administration of a placebo in addition to the usual treatment

  • an experimental group: treated with ivermectin 400 µg / kg in addition to the usual treatment.

The primary endpoint: negation of the RT-PCR test on nasopharyngeal samples of SARS-CoV-2 on D3 of taking Ivermectin compared to the control group (placebo).

The secondary endpoints are:
  • Evolution of symptoms from D0 to D28,

  • SARS-CoV-2 viral load negativation kinetics measured on D0, D3, D7, D14 after treatment by ivermectin,

  • comparison of the number of RT-PCR amplification cycles (Ct: Cycle threshold) in each group,

  • number of patients having recourse to home oxygen therapy,

  • number of patients hospitalized and / or requiring oxygen therapy,

  • number of patients admitted to intensive care,

  • number of deaths.

200 patients will be enrolled: 100 patients for each randomization group.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, multicenter, double-blind, randomized trial in two parallel groupsProspective, multicenter, double-blind, randomized trial in two parallel groups
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Patients will be randomized into one of two groups in a 1: 1 ratio The randomization will be centralized and carried out electronically by IWRS.
Primary Purpose:
Treatment
Official Title:
Evaluation of the Impact of the Administration of Single Dose of Ivermectin in the Early Phase of COVID-19 on the Time to Negativation of the SARS-COV-2 Viral Load Determinated by RT-PCR
Actual Study Start Date :
May 28, 2021
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ivermectin

Ivermectin 3mg, on tablet. As a single dose of 400 µg / kg orally (rounded down to the nearest unit). T+ usual care

Drug: Ivermectin
ivermectin placebo
Other Names:
  • placebo
  • Placebo Comparator: control

    placebo of ivermectin administered in the same manner as the active drug in experimental arm + usual care

    Drug: Ivermectin
    ivermectin placebo
    Other Names:
  • placebo
  • Outcome Measures

    Primary Outcome Measures

    1. negativation of the RT-PCR test on nasopharyngeal samples of SARS-CoV-2 [Day 3]

      negativation of the RT-PCR test on nasopharyngeal samples of SARS-CoV-2 on D3 of taking Ivermectin compared to the control group (placebo).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patient ≥ 18 years old,

    • symptomatic COVID-19 for less than 96 hours (see list of symptoms in appendix),

    • tested positive for SARS-CoV-2 by RT-PCR on a nasopharyngeal sample within 48 hours of inclusion,

    • following an effective method of contraception for women of childbearing age,

    • affiliated to a social security scheme,

    • informed and written consent from patient.

    Exclusion Criteria:
    • patient requiring normal hospitalization or intensive care

    • oxygen-requiring patient,

    • with a history of parasitosis, in particular filariasis,

    • with a history of hypereosinophilia,

    • notion of recent travel (less than 3 months) in poor hygienic conditions

    • taking ivermectin in the last 12 months,

    • contraindications to ivermectin or one of the constituents of the drug (known history of allergies),

    • pregnant or breastfeeding women,

    • participation in another interventional study relating to COVID-19 concerning a drug during this research,

    • patient under AME or without social security coverage.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 GHI Le Raincy Montfermeil Montfermeil France 93370

    Sponsors and Collaborators

    • Raincy Montfermeil Hospital Group

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Raincy Montfermeil Hospital Group
    ClinicalTrials.gov Identifier:
    NCT05040724
    Other Study ID Numbers:
    • 2020-005423-37
    First Posted:
    Sep 10, 2021
    Last Update Posted:
    Sep 10, 2021
    Last Verified:
    Jun 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 10, 2021