Efficacy and Safety of Ivermectin Against Dengue Infection

• ClinicalTrials.gov Identifier: NCT02045069
• Recruitment Status: Unknown
• First Posted: January 24, 2014
• Last Update Posted: November 1, 2015
• Sponsor: Mahidol University
• Collaborator: Ministry of Health, Thailand
• Information provided by (Responsible Party): Mahidol University

Tracking Information

• First Submitted Date: January 13, 2014
• First Posted Date: January 24, 2014
• Last Update Posted Date: November 1, 2015
• Study Start Date: February 2014
• Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 22, 2014): Time to resolution of viremia [ Time Frame: Every 12 hr, from date of randomization until resolution of viremia or until fever subsides for 1 day, whichever came first. ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 22, 2014)

• Time to clearance of NS1 antigen [ Time Frame: Every 12 hr, from date of randomization until resolution of viremia or until fever subsides for 1 day, whichever came first. ]
• Time of subsidence of fever [ Time Frame: From date of randomization until fever subsides ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety of Ivermectin Against Dengue Infection
• Official Title: A Phase II/III, Randomized, Placebo Controlled Trial of Efficacy and Safety of Ivermectin in Children and Adult Patients With Dengue Infection
• Brief Summary: This is a Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of Ivermectin in Children and Adult patients with Dengue Infection.
• Detailed Description: Patients with confirmed dengue infection who meet all inclusion and exclusion criteria will be enrolled in the study and admitted in the hospital. Patients will be randomly assigned in a pre-specified ratio of 1:1:1 to one of the following study groups: ivermectin 200-400 µg/kg single daily dose for 2 days, ivermectin 200-400 µg/kg single daily dose for 3 days, or placebo. Tablets of ivermectin or placebo will be administered for 3 days. Clinical exam will be performed daily during hospitalization and blood samples will be collected for hematology, clinical chemistry, serology, viral load and quantitative nonstructural 1 (NS1) antigen. Safety assessment will be conducted during admission. Patients will be discharged one day after fever subsidence and will be asked to return 2 weeks after first dose of study medication for safety assessment and blood sampling.
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Dengue Fever

Intervention

• Drug: 2 days Ivermectin
  200-400 µg/kg once daily for 2 days and placebo once daily at D3
  Other Names:

  • Mectizan
  • Ivomec
  • Stromectol
• Drug: 3 days Ivermectin
  200 -400 µg/kg once daily for 3 days
• Drug: Placebo
  Placebo once daily for 3 days

Study Arms

• Experimental: 2 days Ivermectin
  Ivermectin 200 - 400 µg/kg once daily for 2 days
  Intervention: Drug: 2 days Ivermectin
• Experimental: 3 days Ivermectin
  Ivermectin 200-400 µg/kg once daily for 3 days
  Intervention: Drug: 3 days Ivermectin
• Placebo Comparator: Placebo
  Placebo
  Intervention: Drug: Placebo

• Publications *: Ooi EE. Repurposing Ivermectin as an Anti-dengue Drug. Clin Infect Dis. 2021 May 18;72(10):e594-e595. doi: 10.1093/cid/ciaa1341. No abstract available.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 22, 2014): 360
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2016
• Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Adults ages of 15 or greater.
• History or presence of fever (temperature > 38°C) of ≤ 72 hr duration.
• Clinical suspicion of dengue infection such as high fever without an evidence or suspected focus of infection on clinical examination.
• Positive NS 1 strip assay

Exclusion Criteria:

• Clinically significant abnormal laboratory results which are deemed to be unassociated with dengue infection
• Clinical evidence or a history of significant respiratory, metabolic, renal, hepatic, hematologic or chronic diseases
• History of autoimmune, immune dysfunction disorder or taking warfarin
• Clinical suspicion of any bacterial infection
• Pregnancy and lactating women

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 15 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Thailand

Administrative Information

• NCT Number: NCT02045069
• Other Study ID Numbers: ESIDEN
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Mahidol University
• Original Responsible Party: Same as current
• Current Study Sponsor: Mahidol University
• Original Study Sponsor: Same as current
• Collaborators: Ministry of Health, Thailand

Investigators

• Principal Investigator: Panisadee Avirutnan, MD, PhD.; Division of Dengue Hemorrhagic Fever Research Department of Research and Development, Faculty of Medicine Siriraj Hospital Mahidol University, Bangkok 10700, THAILAND

• PRS Account: Mahidol University
• Verification Date: October 2015