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

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Raincy Montfermeil Hospital Group
• Treatments: Ivermectin

Criteria

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.