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

Primary Purpose

Onchocerciasis, Ocular, Loiasis

Status

Completed

Phase

Phase 2

Locations

Congo

Study Type

Interventional

Intervention

LEV 1 mg/kg

LEV 1,5 mg/kg

LEV 2,5 mg/kg

Placebo

About this trial

This is an interventional treatment trial for Onchocerciasis, Ocular

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Secteur opérationnelle de la Santé, Ministère de la Santé et de la Population

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

LEV 1 mg/kg

LEV 1,5 mg/kg

LEV 2,5 mg/kg

Placebo

Arm Description

Tablets of LEV at 1 mg/kg will be administrated to the participant ; in single dose only one time. The number of tablets of LEV of 50 mg or 10 mg will be adapted according to the weight of the participant.

Tablet of LEV at 1,5 mg/kg will be administrated to the participant ; in single dose only one time. The number of tablets of LEV of 50 mg or 10 mg will be adapted according to the weight of the participant.

Tablet of LEV at 2,5 mg/kg will be administrated to the participant ; in single dose only one time. The number of tablets of LEV of 50 mg or 10 mg will be adapted according to the weight of the participant.

Tablets of placebo will be administrated to the participant in single dose only one time.

Outcomes

Primary Outcome Measures

Safety and tolerability of levamisole

Absence of severe adverse events during the first week

Incidence of adverse events with levamisole

Proportion of adverse events during the first week

Secondary Outcome Measures

Efficacy of levamisole

Proportion of reduction of the microfilarial density of Loa loa at Day 2, Day 7, and Month 1

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

Full Information

NCT ID

NCT04049630

First Posted

July 26, 2019

Last Updated

September 14, 2021

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT04049630

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

January 16, 2021 (Actual)

Primary Completion Date

April 24, 2021 (Actual)

Study Completion Date

July 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Onchocerciasis, Ocular, Loiasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

255 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LEV 1 mg/kg

Arm Type

Experimental

Arm Description

Arm Title

LEV 1,5 mg/kg

Arm Type

Experimental

Arm Description

Arm Title

LEV 2,5 mg/kg

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Tablets of placebo will be administrated to the participant in single dose only one time.

Intervention Type

Drug

Intervention Name(s)

LEV 1 mg/kg

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

LEV 1,5 mg/kg

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

LEV 2,5 mg/kg

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

5 tablets of placebo will be administrated to the participants.

Primary Outcome Measure Information:

Title

Safety and tolerability of levamisole

Description

Absence of severe adverse events during the first week

Time Frame

1 week

Title

Incidence of adverse events with levamisole

Description

Proportion of adverse events during the first week

Time Frame

1 week

Secondary Outcome Measure Information:

Title

Efficacy of levamisole

Description

Proportion of reduction of the microfilarial density of Loa loa at Day 2, Day 7, and Month 1

Time Frame

Day 2, Day 7, and Month 1

Title

Proportion of individuals without microfilariae of Loa loa

Description

Proportion of individuals with a diminution of 40% and 80% and more of the microfilarial density at Day 7 and Month 1

Time Frame

Day 7 and 1 Month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Facility Information:

Facility Name

Secteur opérationnelle de la Santé, Ministère de la Santé et de la Population

City

Sibiti

Country

Congo

12. IPD Sharing Statement

Citations:

PubMed Identifier

34651190

Citation

Campillo JT, Bikita P, Hemilembolo M, Louya F, Missamou F, Pion SDS, Boussinesq M, Chesnais C. Safety and Efficacy of Levamisole in Loiasis: A Randomized, Placebo-controlled, Double-blind Clinical Trial. Clin Infect Dis. 2022 Aug 24;75(1):19-27. doi: 10.1093/cid/ciab906.

Results Reference

derived

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

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