Oral Ivermectin for Chikungunya Viral Infection

February 12, 2024 updated by: Sarunyou Chusri, Prince of Songkla University

A Randomized Controlled Trial of Oral Ivermectin for Patients With Chikungunya Viral Infection During Urban Outbreak in Southern Thailand

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Songkhla
      • Hat Yai, Songkhla, Thailand, 90110
        • Prince of Songkla University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients received oral ivermectin, adjunctive to conventional treatment
Drug: Ivermectin
3-day 1 daily dose of 400 μg/kg oral ivermectin
No Intervention: Patients received conventional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Day of fever clearance
Time Frame: 1 week
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Day of virologic clearance
Time Frame: 1 week
120 participants would be obtained blood examination for virological testing every day until virological clearance at least in 7 days
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prince of Songkla University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

January 26, 2024

Study Registration Dates

First Submitted

January 26, 2024

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Estimated)

February 14, 2024

Study Record Updates

Last Update Posted (Estimated)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC:55-141-14-1-3/sub1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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