UnknownPhase 4

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

Thailand80 participantsStarted 2020-07-13

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adverse event rates

Timeframe: after first dose until day 28 of follow up

Efficacy for shortening duration of SAR-CoV2 detection by PCR

Timeframe: weekly after treatment until 4th week

Trial details

NCT IDNCT04435587

SponsorMahidol University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06

Contact for this trial

Yupin Suputtamongkol, MD

+66817545573 ysuputtamongkol@gmail.com

View on ClinicalTrials.gov More Asymptomatic Infections trials