NCT04435587

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

Comparative Efficacy of Ivermectin Versus Combination of Hydroxychloroquine Plus Darunavir/ Ritonavir for Shortening Duration of SARS-CoV2 Detection From Respiratory Secretion Among Asymptomatic or Afebrile COVID-19 Infection

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Asymptomatic Infections
• SARS-CoV2 Infection

Interventions

Type	Name	Description
DRUG	Ivermectin Pill	3 days of once daily oral ivermectin 600mcg/kg/d
DRUG	Combined ART/hydroxychloroquine	1. Day 1 hydroxychloroquine 400mg bid, Day2-5 hydroxychloroquine 200mg bid 2. Darunavir/ritonavir (400/100mg) q 12 hours for 5 days

Timeline

• Start date: 2020-07-13
• Primary completion: 2021-06-01
• Completion: 2021-11-01
• First posted: 2020-06-17
• Last updated: 2021-01-11

Locations

4 sites across 1 country: Thailand