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

NCT04417257 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: LAU-20-01
• Study Type: interventional
• Target: 351
• Locations: 2 countries
• Sites: 29

Brief 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.

Conditions

COVID-19 Disease

Keywords

Inflammation; Antiviral; Host-directed treatment; Docosahexaenoic acid; Pro-resolving

Outcome Measures

Primary Outcomes (2)

• Primary Outcome for Phase 2: Proportion of Participants Alive and Free of Respiratory Failure by Day 29 (Ordinal Scale Scores 1-4, Inclusively)

  This will be assessed through health status scoring using the WHO 7-point Ordinal Scale, a higher score is worse than a low score. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death

  On Day 29

• Primary Outcome for Phase 3: Proportion of Participants Requiring Mechanical Ventilation (Includes Extra-corporeal Membrane Oxygenation - ECMO) AND/OR Deceased (All Causes) by Day 60 (Ordinal Scale Scores 1-4, Inclusively)

  This will be assessed through health status scoring using the WHO 7-point Ordinal Scale, a higher score is worse than a low score. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death

  By Day 60

Secondary Outcomes (22)

• The Safety of LAU-7b Therapy, Overview.

  From baseline to Day 60

• The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group

  From baseline to Day 60

• Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups.

  On Days 14 and 29

• For Phase 2 Portion: Rate of All-causes Death by Day 29, Depicted by a Change From Baseline in the Ordinal Scale Score to Category 7

  On Day 29

• For Phase 3 Portion: Rate of All-causes Death by Day 29, Depicted by a Change From Baseline in the Ordinal Scale Score to Category 7

  On Day 29

Study Arms (2)

LAU-7b

EXPERIMENTAL

Active drug as LAU-7b capsules

Drug: LAU-7b

Placebo

PLACEBO COMPARATOR

Placebo oral capsule (as inactive capsules identical to active arm)

Drug: Placebo oral capsule

Interventions

LAU-7b DRUG

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.

Also known as: fenretinide

LAU-7b

Placebo oral capsule DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant exhibited symptoms \[Extension Phase 3 study only: (including at least one lower respiratory symptom such as shortness of breath or dyspnea)\] of COVID-19 disease at screening and/or since the start of their hospitalization (may have included treated symptoms)
• Participant was 18 years and older, of either gender
• Participant must have had at least one of the following factors/co-morbidities:
• Controlled or uncontrolled diabetes
• Pre-existing cardiovascular disease, including hypertension
• Pre-existing respiratory disease such as chronic obstructive pulmonary disease(COPD), asthma, emphysema
• Active \[Extension Phase 3 study only: or a former smoker\] with 20 pack-years of smoking history
• Obesity as depicted by BMI ≥30 kg/m2
• Laboratory tests indicative of a higher risk of COVID-19-related complications, such as troponin \>1.5 the upper limit of normal (ULN), \[Extension Phase 3 study only: D-dimer \>3.0 ULN\] and/or C reactive protein (CRP) \>1.5 ULN
• Aged 70 years and older who, based on the judgment of the investigator, was at a higher risk of developing complications
• Participant had a documented positive test for the SARS-CoV-2 virus \[Pilot Phase 2 study only: or was suspected to be positive and with a test result pending\]. \[Extension Phase 3 study only: Co-infection with other viral respiratory infections was allowed and had to be documented in medical history\]
• Participant was under observation by, or admitted to, a controlled facility or hospital \[Extension Phase 3 study only: for no more than 48 hours (72 hours from amendment 3 onwards) before screening, including any prior stay in another hospital\] to receive standard of care (SoC) for COVID-19 disease
• \[Pilot Phase 2 study only: Participant's hs was 3, 4, or 5 on the WHO ordinal scale and not previously a "6"\] \[Extension Phase 3 study only: 3 or 4 on the World Health Organization (WHO) ordinal scale and not previously a "5 or a 6"\]
• If female, participant was either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who were capable of conception had to be practicing a highly effective method of birth control (acceptable methods included intrauterine device, complete abstinence, spermicide + barrier, male partner surgical sterilization, or hormonal contraception) during the study and through 30 days after the last dose of the study medication. Periodical abstinence was not classified as an effective method of birth control. A pregnancy test had to be negative at the Screening Visit
• Participant had the ability to understand and give informed consent, which could have been verbal with a witness, according to local requirements

You may not qualify if:

• Pregnancy or breastfeeding
• Health condition deemed to possibly interfere with the study endpoints and/or the safety of the participants. For example, the following conditions were considered contraindicated for participation in the study, but this was not an exhaustive list. In case of doubt, the investigator was to consult with the Sponsor's medical representative:
• Presence of inherited retinitis pigmentosa
• Presence or history of liver failure (Child-Pugh B or C)
• Presence or history of stage 4 severe chronic kidney disease or dialysis requirement
• Febrile neutropenia
• \[Pilot Phase 2 study: Presence of active cancer treated with systemic chemotherapy or radiotherapy\]\[Extension Phase 3 study: Presence of end-stage cancer\]
• Known history of a severe allergy or sensitivity to retinoids, or with known allergies to excipients in the oral capsule formulation used in the study
• Participation in another drug clinical trial within 30 days (or a minimum of 5 t½) prior to screening, except ongoing participation in non-interventional studies
• Calculated creatinine clearance (CrCl), using the Cockroft-Gault equation for example \[Pilot Phase 2 study: \<60 mL/min\] \[Extension Phase 3 study: \<30 mL/min)\]
• Presence of total bilirubin \>1.5 x ULN (in the absence of demonstrated Gilbert's syndrome), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>2.5 x ULN
• \[Extension Phase 3 study only: Subject expected to be transferred to ICU or die in the next 24 hours\]

Sponsors & Collaborators

• Laurent Pharmaceuticals Inc.: lead

Study Sites (29)

Chandler Regional Medical Center / Mercy Gilbert Medical Center

Chandler, Arizona, 85224, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Nuvance Health - Danbury Hospital

Danbury, Connecticut, 06810, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Baptist Medical Center Beaches

Jacksonville Beach, Florida, 32250, United States

Location

St Lukes Hospital

Boise, Idaho, 83702, United States

Location

NorthShore University Health System - Swedish Hospital

Chicago, Illinois, 60625, United States

Location

NorthShore University Health System - Glenbrook Hospital

Glenview, Illinois, 60026, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Anne Arundel Medical Center, 2001 Medical Parkway, Belcher Pavillion

Annapolis, Maryland, 21401, United States

Location

Wayne State University, Harper University Hospital and Detroit Receiving Hospital

Detroit, Michigan, 48201, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

Staten Island University Hospital North

Staten Island, New York, 10305, United States

Location

Wake Forest University Health Science

Winston-Salem, North Carolina, 27157, United States

Location

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Kettering Health

Kettering, Ohio, 45429, United States

Location

Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

PRX Research /Dallas Regional Medical Center

Mesquite, Texas, 75149, United States

Location

University of Utah Health

Salt Lake City, Utah, 84112, United States

Location

Centre d'études cliniques CIUSS SLJ, Hôpital Chicoutimi

Chicoutimi, Quebec, G7H 5H6, Canada

Location

CIUSSSS de l'Est-de-l'Ile-de-Montréal, Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X2P1, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

CISSS Des Laurentides

Saint-Jérôme, Quebec, J7Z 5T3, Canada

Location

MeSH Terms

Conditions

Inflammation

Interventions

Fenretinide

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Limitations and Caveats

The Pilot Phase 2 was conducted prior to the Omicron variants and completed normally. Participants with Health Status 3 + 4 grouped together were further studied in a Phase 3 extension, conducted with Omicron variants and vaccination. The Phase 3 was terminated early for futility due to lack of aggravation events (primary efficacy endpoint). The Phase 3 SAP pre-specified the efficacy analyses performed under such a scenario.

Results Point of Contact

• Title: Vice president Clinical Development
• Organization: Laurent Pharmaceuticals Inc.

jmhoule@laurentpharma.com

514-941-2313

Study Officials

• Jean-Marie Houle, PhD

  Laurent Pharmaceuticals Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomly assigned to take either the active drug (LAU-7b capsule) or a matching inactive placebo (inactive capsule)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized, parallel groups and placebo-controlled trial

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 4, 2020
• Study Start: August 18, 2020
• Primary Completion: February 15, 2024
• Study Completion: May 30, 2024
• Last Updated: November 13, 2025
• Results First Posted: November 13, 2025

Record last verified: 2025-10

Locations

CA (6); US (23)