NCT06252961

A 3- to 5-day Clinical Trial of Levamisole in Loiasis Infected Subjects

Randomized, Double-blind Trial Evaluating the Safety and Efficacy of a 3- or 5- Day Course of Levamisole 2.5 mg/kg in Subjects With Loa Loa Microfilaremia

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: Programme National de Lutte contre l'Onchocercose, Republic of the Congo · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate the safety and efficacy of a 3- and 5-day course of levamisole (2.5 mg/kg) in management of loiasis microfilaremia.

Detailed description

Onchocerciasis and loiasis are parasitic diseases caused by Onchocerca volvulus and Loa loa, respectively. Onchocerciasis is endemic in 31 African countries, parts of South America, and Yemen, affecting around 37 million people, while loiasis is present in Central Africa, infecting approximately 15 million individuals. Both diseases are associated with severe complications and increased mortality. African countries have implemented mass drug administration (MDA) programs using ivermectin to combat onchocerciasis. However, co-endemic loiasis poses challenges due to the risk of severe adverse events. Current strategies involve alternative treatments and chemoprophylaxis to accelerate onchocerciasis elimination. The project aims to evaluate the use of levamisole as an alternative treatment. This project will assess the safety and efficacy of administering levamisole for 3 and 5 days to reduce Loa microfilarial density. Previous research demonstrated the safety of a single dose of levamisole but indicated the need for longer treatment regimens to achieve a significant reduction in Loa microfilarial density. The project aims to test whether 3- and 5-day levamisole regimens induce an acceptable safety profile and a stronger reduction in Loa microfilarial density.

Conditions

• Loiasis

Interventions

Type	Name	Description
DRUG	Levamisole 3 days	Levamisole for 3 days (2,5 mg/kg) then placebo for 2 days
DRUG	Levamisole 5 days	Levamisole for 5 days (2,5 mg/kg)
DRUG	Placebo	Placebo for 5 days

Timeline

• Start date: 2024-06-21
• Primary completion: 2024-09-18
• Completion: 2026-02-01
• First posted: 2024-02-12
• Last updated: 2024-09-20

Locations

2 sites across 1 country: Republic of the Congo