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
| Type | Name | Description |
|---|---|---|
| DRUG | LAU-7b for 3 cycles | Three cycles of 14 days of once-a-day intake of LAU-7b, each followed by a treatment intake pause of 14 days. |
| DRUG | LAU-7b for 1 cycle, then placebo | One 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. |
| OTHER | Placebo for 3 cycles | Three 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.