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

NCT05040724 | Unknown Phase 3

• 1 other identifier: 2020-005423-37
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

To Assess the Reduction in the Viral Load of SARS-CoV-2 in Patients Receiving Ivermectin Compared to Those Receiving Standard Care

Outcome Measures

Primary Outcomes (1)

• negativation of the RT-PCR test on nasopharyngeal samples of SARS-CoV-2

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

  Day 3

Study Arms (2)

Ivermectin

EXPERIMENTAL

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

Drug: Ivermectin

control

PLACEBO COMPARATOR

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

Drug: Ivermectin

Interventions

Ivermectin DRUG

ivermectin placebo

Also known as: placebo

Ivermectin; control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient ≥ 18 years old,
• symptomatic COVID-19 for less than 96 hours (see list of symptoms in appendix),
• following an effective method of contraception for women of childbearing age,
• affiliated to a social security scheme,
• informed and written consent from patient.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Raincy Montfermeil Hospital Group: lead

Study Sites (1)

GHI Le Raincy Montfermeil

Montfermeil, 93370, France

Location

MeSH Terms

Interventions

Ivermectin

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, double-blind, randomized trial in two parallel groups

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 10, 2021
• Study Start: May 28, 2021
• Primary Completion: May 1, 2022
• Study Completion: June 1, 2022
• Last Updated: September 10, 2021

Record last verified: 2021-06

Locations

FR (1)