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

• Status: Recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mahidol University
• Treatments: Darunavir; Hydroxychloroquine; Ivermectin; Ritonavir

Criteria

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