Ivermectin vs Combined Hydroxychloroquine and Antiretroviral Drugs (ART) Among Asymptomatic COVID-19 Infection
IDRA-COVID19
Comparative Efficacy of Ivermectin Versus Combination of Hydroxychloroquine Plus Darunavir/ Ritonavir for Shortening Duration of SARS-CoV2 Detection From Respiratory Secretion Among Asymptomatic or Afebrile COVID-19 Infection
1 other identifier
interventional
80
1 country
4
Brief Summary
This is an open label randomised controlled study of oral ivermectin (600 mcg/kg/d\* 3 day) versus combined of hydroxychloroquine plus darunavir/ ritonavir for 5 days treatment among asymptomatic carrier of SAR-CoV2 adult Thai population. Both study treatment regimens will have oral zinc sulfate combination treatment ( 200mg. twice daily). Outcomes include safety and duration of detectable of SAR-CoV2 in nasopharyngeal/ throat (NP) swab by polymerase chain reaction amplification (PCR) after treatment. 40-50 patients in each treatment arm is planned, with an interim analysis when approximately 50% of cases is enrolled.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2020
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2020
CompletedFirst Posted
Study publicly available on registry
June 17, 2020
CompletedStudy Start
First participant enrolled
July 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedJanuary 11, 2021
January 1, 2021
11 months
June 15, 2020
January 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adverse event rates
Comparison of adverse event rates between treatment arms
after first dose until day 28 of follow up
Efficacy for shortening duration of SAR-CoV2 detection by PCR
comparison of median duration for detectable SAR-CoV2 by PCR from NP swab in each arm
weekly after treatment until 4th week
Secondary Outcomes (1)
Antibody detection rates
weekly after treatment until 4th week
Study Arms (2)
ivermectin
EXPERIMENTALCombination of 1. oral ivermectin 600 mcg/kg/day once daily for 3 days 2. Zinc sulfate (100mg/tab) 2 tab every 12 hours for 3 days
ART/hydroxychloroquine
ACTIVE COMPARATORCombination of 1. Day1 hydroxychloroquine 400mg bid, then 200mg bid on Day 2-5 2. Darunavir/ritonavir (400/100mg) every 12 hours for 5 days 3. Zinc sulfate (100/tab) 2 tab every 12 hours for 5 days
Interventions
3 days of once daily oral ivermectin 600mcg/kg/d
1. Day 1 hydroxychloroquine 400mg bid, Day2-5 hydroxychloroquine 200mg bid 2. Darunavir/ritonavir (400/100mg) q 12 hours for 5 days
Eligibility Criteria
You may qualify if:
- SAR-CoV2 detected by PCR from NP swab
- Asymptomatic or upper respiratory symptoms such as runny noses
- No history of fever or oral Temp \<37.8 degree celsius
- informed consent obtained
You may not qualify if:
- Fever or respiratory rate \>24/minute or oxygen saturation at room air\< 94%
- Any serious co-morbidity such as chronic lung disease, chronic kidney disease, cardiovascular diseases, arrythmia, diabetes mellitus with HbA1C \> 8%, chronic liver disease, lymphocyte count \<1,000cell/cu.mm.
- History of ivermectin or any of the study drug allergy.
- Concomitant medication with potential drug interaction with any of the study drugs such as alfuzosin, colchicine, ergot derivatives, cisapride, simvastatin and rifampicin
- Pregnant or lactating woman
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Siriraj Hospital
Bangkok Noi, Bangkok, 10700, Thailand
Siriaj Hospital
Bangkok, N/A = Not Applicable, 10700, Thailand
Sireethorn Nimitvilai
Amphoe Maueng, Nakhonpathom, 73000, Thailand
Golden Jubilee Medical Center
Phutthamonthon District, Nakhonpathom, 73170, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yupin Suputtamongkol, MD
Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- PCR for SAR-CoV2 detection will be performed by technician without knowledge of treatment arm
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 15, 2020
First Posted
June 17, 2020
Study Start
July 13, 2020
Primary Completion
June 1, 2021
Study Completion
November 1, 2021
Last Updated
January 11, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share