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LAU-7b for Post-COVID Syndrome (ESSOR Trial)

Phase 2 & 3
Waitlist Available
Research Sponsored by Laurent Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
If female, must meet specific criteria related to menopause, sterilization, or birth control, and must have a negative pregnancy test at the Screening Visit
At least one of the Long COVID symptoms must be from the core list of Long COVID symptoms, and be present for a minimum of 2 weeks prior to screening and of moderate or severe intensity as per the 4-level Likert severity scale
Must not have
Subject is currently hospitalized (any reason)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 4, 8 and 12
Awards & highlights

Summary

This trial will test if an oral antiviral drug can reduce symptoms of Long COVID in adults with moderate to severe symptoms.

Who is the study for?
Adults over 18 with Long COVID, experiencing specific symptoms for at least 12 weeks post-infection. Participants must be able to swallow capsules, follow the study protocol including ePRO or paper questionnaires, and have stable health as judged by lab tests and vital signs. Women of childbearing potential must use birth control and have a negative pregnancy test.
What is being tested?
The ESSOR trial is testing LAU-7b, an oral medication thought to fight viruses and control inflammation in adults with Long COVID. It's a double-blind study where patients randomly receive either LAU-7b or a placebo for up to three cycles without knowing which one they're getting.
What are the potential side effects?
While the side effects of LAU-7b are not detailed here, similar antiviral and anti-inflammatory drugs can cause issues like headache, nausea, digestive problems, skin reactions or increased liver enzymes. Allergic reactions could occur in those sensitive to retinoids or capsule ingredients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman following the required birth control guidelines or am not of childbearing potential, and my pregnancy test was negative.
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I have had severe Long COVID symptoms from the core list for at least 2 weeks.
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I can swallow pills without difficulty.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently in the hospital.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 4, 8 and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 4, 8 and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in Physical Functioning Score (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Week 12
Secondary study objectives
Change from baseline in Physical Functioning Score (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Weeks 4 and 8
Change from baseline in the DePaul Post-Exertional Malaise Questionnaire (DPEMQ)
Change from baseline in the EQ-5D-5L score
+13 more
Other study objectives
Changes relative to baseline (percent change) of systemic biomarkers of hematologic, inflammation and immunologic functions
Health and survival follow-up 1
Health and survival follow-up 2

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: LAU-7b for 3 cyclesExperimental Treatment1 Intervention
Each study arm will consist of three (3) cycles of 14 days of treatment intake each spaced by a treatment holiday of 14 days.
Group II: LAU-7b for 1 cycle, then placeboExperimental Treatment1 Intervention
Each study arm will consist of three (3) cycles of 14 days of treatment intake each spaced by a treatment holiday of 14 days.
Group III: Placebo for 3 cyclesPlacebo Group1 Intervention
Each study arm will consist of three (3) cycles of 14 days of treatment intake each spaced by a treatment holiday of 14 days.

Find a Location

Who is running the clinical trial?

Laurent Pharmaceuticals Inc.Lead Sponsor
2 Previous Clinical Trials
291 Total Patients Enrolled
1 Trials studying COVID-19
125 Patients Enrolled for COVID-19
Jean-Marie Houle, PhDStudy DirectorLaurent Pharmaceuticals Inc.
1 Previous Clinical Trials
125 Total Patients Enrolled
1 Trials studying COVID-19
125 Patients Enrolled for COVID-19
~148 spots leftby Sep 2025
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