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

Loiasis Clinical Trial

— EOLoa  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04049630
• Other study ID #: EOLoa/LEV
• Status: Completed
• Phase: Phase 2
• Start date: January 16, 2021
• Est. completion date: July 15, 2021

Study information

• Verified date: September 2021
• Source: Programme National de Lutte contre l'Onchocercose, Republic of the Congo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: July 15, 2021
• Est. primary completion date: April 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Written consent written, signed (or with thumbprint) and dated

• Aged 18 to 65 inclusive

• Individual microfilarial density = 1mf/mL

• Body weight = 40 kg in women and = 45 kg in men; and less than 85 kg

• In good health condition, as determined by the medical questionnaire and the general clinical examination: absence of acute or chronic infection

Exclusion Criteria:

• Participation in any study other than purely observational, in the 4 weeks preceding this study (determined by the theoretical date of administration of LEV or placebo).

• Any vaccination in the 4 weeks preceding this study.

• Acute infection requiring a treatment in the 10 days preceding this study, determined by the anamnesis during the medical interview (example: pulmonary infection, ENT, digestive, cutaneous, with implementation of an antibiotic treatment or not)

• Warfarin treatment

• Treatment with clozapine, phenythiazines, sulfasalazine, carbamazepine, synthetic antithyroid, ticlopidine, cimetidine, and gold salts: whether it is a long-term treatment, or a treatment given in a single dose 10 days before the start of treatment for the clinical trial (precaution of use compared to the risk of agranulocytosis of immuno-allergic or toxic origin)

• Known immunosuppressive pathology

• Past or current history of neurological (including epilepsy) or neuropsychiatric disease

• History of agranulocytosis

• Consumption of alcohol, taking cocaine or other drugs of abuse in the 72 hours preceding the administration of the treatment of the test determined by the anamnesis during the medical interview

• Any condition, in the opinion of the investigator, which exposes the subject to an undue risk

• Known intolerance to levamisole

• Subjects who gave blood in the 8 weeks before entry into the study, with a standard volume (> 500 mL)

• During the clinical examination: symptoms, physical signs or biological constants suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, cutaneous, immunodeficiency, psychiatric disorders and other abnormalities likely to interfere with the interpretation results of the test. The doctor may then give a favorable or unfavorable opinion for the inclusion of the participant

• Taking IVM and / or LEV during the last six months; and / or mebendazole or albendazole in the last month

• Pregnant and lactating women (based on self-declaration)

Related Conditions & MeSH terms

• Loiasis
• Onchocerciasis
• Onchocerciasis, Ocular

Intervention

Drug:
• LEV 1 mg/kg
A combinaison of LEV 10 mg, 50 mg, and placebo will be adapted to the weight ; all the tablets will be blinded, and each participant will receive 5 tablets.
• LEV 1,5 mg/kg
A combinaison of LEV 10 mg, 50 mg, and placebo will be adapted to the weight ; all the tablets will be blinded, and each participant will receive 5 tablets.
• LEV 2,5 mg/kg
A combinaison of LEV 10 mg, 50 mg, and placebo will be adapted to the weight ; all the tablets will be blinded, and each participant will receive 5 tablets.
• Placebo
5 tablets of placebo will be administrated to the participants.

Locations

Country	Name	City	State
Congo	Secteur opérationnelle de la Santé, Ministère de la Santé et de la Population	Sibiti

Sponsors (1)

Lead Sponsor	Collaborator
Programme National de Lutte contre l'Onchocercose, Republic of the Congo

Country where clinical trial is conducted

Congo, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of levamisole	Absence of severe adverse events during the first week	1 week
Primary	Incidence of adverse events with levamisole	Proportion of adverse events during the first week	1 week
Secondary	Efficacy of levamisole	Proportion of reduction of the microfilarial density of Loa loa at Day 2, Day 7, and Month 1	Day 2, Day 7, and Month 1
Secondary	Proportion of individuals without microfilariae of Loa loa	Proportion of individuals with a diminution of 40% and 80% and more of the microfilarial density at Day 7 and Month 1	Day 7 and 1 Month