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

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Laurent Pharmaceuticals Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jean-Marie Houle, PhD

Principal Investigator

Laurent Pharmaceuticals Inc.

Eligibility Criteria

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.

Inclusion Criteria

I am 18 or older and can give my consent.

I am a woman following the required birth control guidelines or am not of childbearing potential, and my pregnancy test was negative.

I have had severe Long COVID symptoms from the core list for at least 2 weeks.

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Exclusion Criteria

Your blood tests show high levels of bilirubin, alanine aminotransferase, or aspartate aminotransferase.

You have had a serious allergic reaction to retinoids or any of the ingredients in the oral capsules used in the study.

I have not had a COVID vaccine in the last 4 weeks and do not plan to get one during the study.

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Treatment Details

Interventions

LAU-7b (Other)
Placebo (Other)

Trial OverviewThe 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.

Participant Groups

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.