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

Overview

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.

* 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.