Clinical Trials Directory

Trials / Completed

CompletedNCT05999435

Study of LAU-7b for the Treatment of Long COVID in Adults

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, ADAPTIVE PHASE 2/3 STUDY OF THE EFFICACY OF LAU-7b IN THE TREATMENT OF ADULTS WITH LONG COVID AND MODERATE TO SEVERE SYMPTOMS

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

Summary

ESSOR is a double-blind, placebo-controlled study of the orally-administered antiviral and inflammation-controlling LAU-7b for the treatment of adults with Long COVID and moderate to severe symptoms.

Detailed description

ESSOR is a multicenter, randomized, double-blind, placebo-controlled Phase 2/3 study of LAU-7b for the treatment of Long COVID in non-hospitalized adults with moderate to severe Long COVID symptoms. The goal of the study is to evaluate the efficacy of LAU-7b therapy + stable symptomatic standard-of-care relative to placebo + stable symptomatic standard-of-care at reducing the overall Long COVID burden by improving multiple dimensions of quality-of-life and alleviating the symptoms. This study is a logical extension of investigating LAU-7b as a potential therapeutic against various phases of COVID-19. LAU-7b is therefore being proposed as a potential disease-modifying medication for the treatment of Long COVID.

Conditions

Interventions

TypeNameDescription
DRUGLAU-7b for 3 cyclesThree cycles of 14 days of once-a-day intake of LAU-7b, each followed by a treatment intake pause of 14 days.
DRUGLAU-7b for 1 cycle, then placeboOne cycle of 14 days of once-a-day intake of LAU-7b followed by two cycles of 14 days of placebo administered similarly, each followed by a treatment intake pause of 14 days.
OTHERPlacebo for 3 cyclesThree cycles of 14 days of once-a-day intake of placebo, each followed by a treatment intake pause of 14 days

Timeline

Start date
2023-11-15
Primary completion
2024-08-05
Completion
2024-11-30
First posted
2023-08-21
Last updated
2026-01-06
Results posted
2026-01-06

Locations

5 sites across 1 country: Canada

Source: ClinicalTrials.gov record NCT05999435. Inclusion in this directory is not an endorsement.