NCT04321174

COVID-19 Ring-based Prevention Trial With Lopinavir/Ritonavir

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Months
• Healthy volunteers: Not accepted

Summary

COVID-19 has rapidly evolved into a generalized global pandemic. Post-exposure prophylaxis (PEP) against on COVID-19 was identified as an urgent research priority by the WHO, and lopinavir/ritonavir (LPV/r) is a promising candidate for both COVID-19 treatment and PEP, with a good safety profile and global availability. This is a cluster randomized controlled trial (RCT) of oral LPV/r as PEP against COVID-19, that will address the immediate need for preventive interventions, generate key data on COVID-19 transmission, and serve as a research platform for future vaccines and preventive agents.

Conditions

• Coronavirus Infections
• Post-exposure Prophylaxis

Interventions

Type	Name	Description
DRUG	Lopinavir/ritonavir	The intervention is a 14-day course of LPV/r 400/100 mg orally twice daily, or equivalent weight-based dosing, to be initiated as soon as possible (within 1-7 days) after the last exposure.

Timeline

• Start date: 2020-04-17
• Primary completion: 2021-08-27
• Completion: 2022-03-31
• First posted: 2020-03-25
• Last updated: 2021-12-14

Locations

4 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study