Oral Ivermectin for Chikungunya Viral Infection

Clinical Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06259383
• Other study ID #: EC:55-141-14-1-3/sub1
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2018
• Est. completion date: January 26, 2024

Study information

• Verified date: February 2024
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 26, 2024
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Clinical Syndrome
• Virus Diseases

Intervention

Drug:
• Ivermectin
3-day 1 daily dose of 400 µg/kg oral ivermectin

Locations

Country	Name	City	State
Thailand	Prince of Songkla University	Hat Yai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day of virologic clearance	120 participants would be obtained blood examination for virological testing every day until virological clearance at least in 7 days	1 week