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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06259383
Other study ID # EC:55-141-14-1-3/sub1
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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