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COVID-19 drug trial halted: LAU-7b studied in hospitalized patients

NCT ID NCT04417257

Disease control Sponsor: Laurent Pharmaceuticals Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called LAU-7b in adults hospitalized with COVID-19 who had health issues like diabetes that put them at higher risk for complications. The goal was to see if LAU-7b could prevent respiratory failure or the need for a breathing machine. The trial was stopped early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

351 people

The number who actually took part.

Started

Aug 2020

Finished

May 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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) 2. Participant was 18 years and older, of either gender 3. Participant must have had at least one of the following factors/co-morbidities: 1. Controlled or uncontrolled diabetes 2. Pre-existing cardiovascular disease, including hypertension 3. Pre-existing respiratory disease such as chronic obstructive pulmonary disease(COPD), asthma, emphysema 4. Active \[Extension Phase 3 study only: or a former smoker\] with 20 pack-years of smoking history 5. Obesity as depicted by BMI ≥30 kg/m2 6. 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 7. Aged 70 years and older who, based on the judgment of the investigator, was at a higher risk of developing complications 4. Participant had a documented positive test for the SARS-CoV-2 virus \[Pilot Phase 2 study only: or was suspected to be positive and with a test result pending\]. \[Extension Phase 3 study only: Co-infection with other viral respiratory infections was allowed and had to be documented in medical history\] 5. 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 6. \[Pilot Phase 2 study only: Participant's hs was 3, 4, or 5 on the WHO ordinal scale and not previously a "6"\] \[Extension Phase 3 study only: 3 or 4 on the World Health Organization (WHO) ordinal scale and not previously a "5 or a 6"\] 7. 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 8. Participant had the ability to understand and give informed consent, which could have been verbal with a witness, according to local requirements 9. Participant was deemed capable of adequate compliance including attending scheduled visits for the duration of the study 10. Participant was able to swallow the study drug capsules Exclusion Criteria: 1. Pregnancy or breastfeeding 2. 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: 1. Presence of inherited retinitis pigmentosa 2. Presence or history of liver failure (Child-Pugh B or C) 3. Presence or history of stage 4 severe chronic kidney disease or dialysis requirement 4. Febrile neutropenia 5. \[Pilot Phase 2 study: Presence of active cancer treated with systemic chemotherapy or radiotherapy\]\[Extension Phase 3 study: Presence of end-stage cancer\] 3. 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 4. 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 5. Calculated creatinine clearance (CrCl), using the Cockroft-Gault equation for example \[Pilot Phase 2 study: \<60 mL/min\] \[Extension Phase 3 study: \<30 mL/min)\] 6. 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 7. \[Extension Phase 3 study only: Subject expected to be transferred to ICU or die in the next 24 hours\]

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Conditions

The condition(s) this trial relates to.

COVID-19 Inflammation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID-19 disease

Contacts and locations

Locations

  • Anne Arundel Medical Center, 2001 Medical Parkway, Belcher Pavillion

    Annapolis, Maryland, 21401, United States

  • Baptist Medical Center Beaches

    Jacksonville Beach, Florida, 32250, United States

  • CISSS Des Laurentides

    Saint-Jérôme, Quebec, J7Z 5T3, Canada

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

    Montreal, Quebec, H1T 2M4, Canada

  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec, H2X2P1, Canada

  • Centre d'études cliniques CIUSS SLJ, Hôpital Chicoutimi

    Chicoutimi, Quebec, G7H 5H6, Canada

  • Chandler Regional Medical Center / Mercy Gilbert Medical Center

    Chandler, Arizona, 85224, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • Kettering Health

    Kettering, Ohio, 45429, United States

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1, Canada

  • MedStar Washington Hospital Center

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

  • NorthShore University Health System - Glenbrook Hospital

    Glenview, Illinois, 60026, United States

  • NorthShore University Health System - Swedish Hospital

    Chicago, Illinois, 60625, United States

  • Nuvance Health - Danbury Hospital

    Danbury, Connecticut, 06810, United States

  • OhioHealth Riverside Methodist Hospital

    Columbus, Ohio, 43214, United States

  • PRX Research /Dallas Regional Medical Center

    Mesquite, Texas, 75149, United States

  • Robert Packer Hospital

    Sayre, Pennsylvania, 18840, United States

  • St Lukes Hospital

    Boise, Idaho, 83702, United States

  • Staten Island University Hospital North

    Staten Island, New York, 10305, United States

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102, United States

  • University of California Davis Medical Center

    Sacramento, California, 95817, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Texas Southwestern

    Dallas, Texas, 75390, United States

  • University of Utah Health

    Salt Lake City, Utah, 84112, United States

  • Wake Forest University Health Science

    Winston-Salem, North Carolina, 27157, United States

  • Wayne State University, Harper University Hospital and Detroit Receiving Hospital

    Detroit, Michigan, 48201, United States

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Other studies related to the condition(s) this trial covers.