Ivermectin vs Combined Hydroxychloroquine and Antiretroviral Drugs (ART) Among Asymptomatic COVID-19 Infection — IDRA-COVID19  

SARS-CoV2 Infection Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Asymptomatic Infections
• Communicable Diseases
• Infection
• SARS-CoV2 Infection

• NCT number: NCT04435587
• Study type: Interventional
• Source: Mahidol University
• Contact: Yupin Suputtamongkol, MD
• Phone: +66817545573
• Email: ysuputtamongkol@gmail.com
• Status: Recruiting
• Phase: Phase 4
• Start date: July 13, 2020
• Completion date: November 2021