drugset / Trial / NCT04435587

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

NCT04435587

Phase 4 Unknown 80 enrolled Mahidol University
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2020-07-13
Primary completion
2021-06
Completion
2021-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Darunavir Small molecule 400 mg
Comparator Hydroxychloroquine Small molecule 200 mg
Subject Ivermectin Small molecule 600 ug/kg Oral
Subject Ritonavir Other / unclassified 100 mg

Indications