Trial of Early Therapies During Non-hospitalized Outpatient Window for COVID-19

NCT04372628 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 452

Last updated 2024-02-28

Study results available
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Summary

Blinded, multicenter, placebo-controlled, randomized clinical trial evaluating lopinavir/ritonavir vs placebo in early outpatient treatment of adults with COVID-19

Conditions

Interventions

DRUG

Lopinavir/Ritonavir 400 mg/100 mg

Lopinavir/Ritonavir tablets

OTHER

Placebo

Unmatched placebo

Sponsors & Collaborators

  • AbbVie

    collaborator INDUSTRY
  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Todd Rice, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2021-12-16
Completion
2022-01-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT04372628 on ClinicalTrials.gov