NCT04372628

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

Trial of Early Therapies During Non-hospitalized Outpatient Window (TREAT NOW) for COVID-19

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 452 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

We will conduct an investigator-initiated, multicenter, blinded, placebo-controlled, randomized clinical trial evaluating lopinavir/ritonavir vs placebo for early treatment of adults with COVID-19 in the outpatient setting prior to hospitalization. Patients, treating clinicians, and study personnel will all be blinded to study group assignment.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Lopinavir/Ritonavir 400 mg/100 mg	Lopinavir/Ritonavir tablets
OTHER	Placebo	Unmatched placebo

Timeline

• Start date: 2020-06-01
• Primary completion: 2021-12-16
• Completion: 2022-01-18
• First posted: 2020-05-04
• Last updated: 2024-02-28
• Results posted: 2023-01-26

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study