Ivermectin vs Combined Hydroxychloroquine and Antiretroviral Drugs (ART) Among Asymptomatic COVID-19 Infection

  • STATUS
    Recruiting
  • days left to enroll
    63
  • participants needed
    80
  • sponsor
    Mahidol University
Updated on 27 January 2021

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.

Description

  • Study procedure will be carried out after informed consent is obtained.
    • 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.

Details
Condition Subclinical infection, asymptomatic infections, asymptomatic infection, SARS-CoV2 Infection, SARS-CoV2 Infection
Treatment Ivermectin Pill, Combined ART/hydroxychloroquine
Clinical Study IdentifierNCT04435587
SponsorMahidol University
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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