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Clinical trial

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

ID
Name
EC:55-141-14-1-3/sub1
Description
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 arms
Trial start
2018-01-01
Estimated PCD
2021-12-31
Trial end
2024-01-26
Status
Completed
Phase
Early phase I
Treatment
Ivermectin
3-day 1 daily dose of 400 μg/kg oral ivermectin
Arms:
Patients received oral ivermectin, adjunctive to conventional treatment
Size
120
Primary endpoint
Day of fever clearance
1 week
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ACTUAL'}}
Updated at
2024-02-14

1 organization

1 product

1 indication

Organization
Prince of Songkla University
Product
Ivermectin
Indication
Clinical Syndrome