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

NCT04321174 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2021-12-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Darrell Tan, MD FRCPC PhD · Unity Health Toronto

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-17
Primary Completion
2021-08-27
Completion
2022-03-31
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04321174 on ClinicalTrials.gov