Clinical Trial Evaluating the Safety and Efficacy of Levamisole in Loa Loa Microfilaremic Patients — EOLoa

Loiasis Clinical Trial

Official title:
Randomized Clinical Trial, Double-blind, Dose-escalating of Drug Intensities, Evaluating the Safety and Efficacy of Levamisole in Loa Loa Microfilaremic Patients

Status Completed

Clinical Trial Summary

This study aims at evaluating the safety and efficacy of levamisole in patients with loiasis infection.

Clinical Trial Description

This clinical trial will be conducted in Republic of Congo. This is a pragmatic and adaptative randomized, double-blind clinical trial. Levamisole will be tested at 1 and 1,5 mg/kg, and compared to placebo (36:36:36); or 2,5 mg/kg compared to placebo (36:36) in case of adaptation of the dose for cohorts II and III. We will perform three cohorts of patients according to the microfilarial density : 1-1,999 mf/ml, 1-14,999 mf/ml, and all microfilaremic individuals; in order to respect the safety potentially related to loiasis. The first cohort was to evaluate the most appropriate dose of levamisole, with a possibility to increase (to 2.5 mg/kg) the dose of levamisole for the cohorts II and III in case of lack of efficacy and in case of good safety profil. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04049630
Study type	Interventional
Source	Programme National de Lutte contre l'Onchocercose, Republic of the Congo
Contact
Status	Completed
Phase	Phase 2
Start date	January 16, 2021
Completion date	July 15, 2021

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See also
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