Ivermectin vs Combined Hydroxychloroquine and Antiretroviral Drugs (ART) Among Asymptomatic COVID-19 Infection
NCT ID: NCT04435587
Last Updated: 2021-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
80 participants
INTERVENTIONAL
2020-07-13
2021-11-30
Brief Summary
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Detailed Description
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* Baseline physical exam and laboratory investigations will be performed.
* Eligible patients will be randomized to one of the two treatment arms.
* Symptoms and signs will be monitored daily.
* NP swab will be done at day5-7, and prior to discharge.
* Complete blood counts, blood chemistries, electrocardiography will be performed for adverse event monitoring within 5 days after end of study drugs' administration.
* Patients will be discharged at 2- 4 weeks after hospitalization, according to PCR results.
* There will be 1-2 follow up visit at out patient clinic for NP swab (patients with +ve last NP swab before discharge), and blood tests.
* Additional 5-8 ml. of EDTA blood will be taken at baseline and weekly for antibody detection.
* Interim analysis of both safety and efficacy will be performed when approximately 50% of enrollment is achieved.
* Intention to treat analysis is planned at the completion of enrollment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ivermectin
Combination 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
Ivermectin Pill
3 days of once daily oral ivermectin 600mcg/kg/d
ART/hydroxychloroquine
Combination 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
Combined ART/hydroxychloroquine
1. Day 1 hydroxychloroquine 400mg bid, Day2-5 hydroxychloroquine 200mg bid
2. Darunavir/ritonavir (400/100mg) q 12 hours for 5 days
Interventions
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Ivermectin Pill
3 days of once daily oral ivermectin 600mcg/kg/d
Combined ART/hydroxychloroquine
1. Day 1 hydroxychloroquine 400mg bid, Day2-5 hydroxychloroquine 200mg bid
2. Darunavir/ritonavir (400/100mg) q 12 hours for 5 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Asymptomatic or upper respiratory symptoms such as runny noses
* No history of fever or oral Temp \<37.8 degree celsius
* informed consent obtained
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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Yupin Suputtamongkol
Professor
Principal Investigators
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Yupin Suputtamongkol, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
Locations
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Siriraj Hospital
Bangkok Noi, Bangkok, Thailand
Siriaj Hospital
Bangkok, N/A = Not Applicable, Thailand
Sireethorn Nimitvilai
Amphoe Maueng, Nakhonpathom, Thailand
Golden Jubilee Medical Center
Phutthamonthon District, Nakhonpathom, Thailand
Countries
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Central Contacts
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Rujipas Sirijatuphat, MD
Role: CONTACT
Facility Contacts
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Other Identifiers
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323/2563 (IRB3)
Identifier Type: -
Identifier Source: org_study_id
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