NCT06259383

Brief Summary

Chikungunya viral infection (CVI) is a mosquito-borne infection, caused by chikungunya virus (CHIKV), an alphavirus, belonging to the family Togaviridae. This infection causes febrile illness associated with high fever, rash, acute deliberating and persistent arthralgia. There is no licensed vaccine or specific treatment for this infection. Ivermectin (IVM), commonly-used antiparasitic, has been demonstrated to inhibit replication of CHIKV.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2018

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

4 years

First QC Date

January 26, 2024

Last Update Submit

February 12, 2024

Conditions

Clinical Syndrome

Outcome Measures

Primary Outcomes (1)

  • Day of fever clearance

    120 participants would be under Body Temperature Assessment - the staff would assess once daily until the fever clearance was below 38C and the measure proportion of patients with fever clearance in each day of assessment until fever clearance at least in 7 days

    1 week

Secondary Outcomes (1)

  • Day of virologic clearance

    1 week

Study Arms (2)

Patients received oral ivermectin, adjunctive to conventional treatment

EXPERIMENTAL
Drug: Ivermectin

Patients received conventional treatment

NO INTERVENTION

Interventions

IvermectinDRUG

3-day 1 daily dose of 400 μg/kg oral ivermectin

Patients received oral ivermectin, adjunctive to conventional treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with virologic confirmation of chikungunya infection who had symptoms less than 72 hours prior to visit

You may not qualify if:

  • patients with virologic confirmation of chikungunya infection who had symptoms more than 72 hours prior to visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Interventions

Ivermectin

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 26, 2024

First Posted

February 14, 2024

Study Start

January 1, 2018

Primary Completion

December 31, 2021

Study Completion

January 26, 2024

Last Updated

February 14, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)