NCT04417257

Study of LAU-7b for the Treatment of Coronavirus Disease 2019 (COVID-19) Disease in Adults

RESOLUTION: A Double-blind, Randomized, Placebo-controlled, Phase II/III Study of the Efficacy and Safety of LAU-7b in the Treatment of Adult Hospitalized Patients With COVID-19 Disease

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 351 (actual)
• Sponsor: Laurent Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A randomized, double-blind, placebo-controlled Phase 2/3 Study of LAU-7b against confirmed COVID-19 Disease in hospitalized patients at a higher risk of complications.

Detailed description

RESOLUTION is a multicenter, randomized, double-blind, placebo-controlled Phase 2/3 study of LAU-7b for the treatment of COVID-19 Disease in participants at a higher risk than the general COVID-19 Disease population to develop complications while hospitalized. The goal of the study is to evaluate the efficacy of LAU-7b therapy + standard-of-care relative to placebo + standard-of-care in participants with COVID-19 Disease with confirmed SARS-CoV-2 infection. SARS is "severe acute respiratory syndrome". CoV is " Coronavirus". The purpose of the treatment with LAU-7b is to prevent the worsening of the health of hospitalized participants including aggravation such as recourse to mechanical ventilation and death. The means are the direct effects of LAU-7b on the resolution of inflammation, interference with viral proliferation and protection from excessive pro-inflammatory response.

Conditions

• COVID-19 Disease

Interventions

Type	Name	Description
DRUG	LAU-7b	LAU-7b will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
DRUG	Placebo oral capsule	Placebo will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.

Timeline

• Start date: 2020-08-18
• Primary completion: 2024-02-15
• Completion: 2024-05-30
• First posted: 2020-06-04
• Last updated: 2025-11-13
• Results posted: 2025-11-13

Locations

29 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study