COVID-19 DiseasePhase 2/3RESOLUTIONNCT04417257

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

A Phase 2/3 study testing LAU-7b in people with COVID-19 Disease, run by Laurent Pharmaceuticals Inc. at 29 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19 Disease
What is being tested?: LAU-7b
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 351 participants
Where: 29 sitesin 2 countries
Study dates: 18 Aug 2020to 30 May 2024
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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
Participant was deemed capable of adequate compliance including attending scheduled visits for the duration of the study
Participant was able to swallow the study drug capsules

Who cannot join

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

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[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]

Trial locations and contacts

29 sites in 2 countries.

Country

City, postcode or hospital

29 sites in 2 countries

United States23 sites

Anne Arundel Medical Center, 2001 Medical Parkway, Belcher Pavillion
Annapolis, Maryland, 21401
St Lukes Hospital
Boise, Idaho, 83702
Chandler Regional Medical Center / Mercy Gilbert Medical Center
Chandler, Arizona, 85224
NorthShore University Health System - Swedish Hospital
Chicago, Illinois, 60625
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, 43214
University of Texas Southwestern
Dallas, Texas, 75390
Nuvance Health - Danbury Hospital
Danbury, Connecticut, 06810
Wayne State University, Harper University Hospital and Detroit Receiving Hospital
Detroit, Michigan, 48201
Henry Ford Health System
Detroit, Michigan, 48202
NorthShore University Health System - Glenbrook Hospital
Glenview, Illinois, 60026
Houston Methodist Hospital
Houston, Texas, 77030
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Baptist Medical Center Beaches
Jacksonville Beach, Florida, 32250
Kettering Health
Kettering, Ohio, 45429
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
PRX Research /Dallas Regional Medical Center
Mesquite, Texas, 75149
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
University of California Davis Medical Center
Sacramento, California, 95817
University of Utah Health
Salt Lake City, Utah, 84112
Robert Packer Hospital
Sayre, Pennsylvania, 18840
Staten Island University Hospital North
Staten Island, New York, 10305
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Wake Forest University Health Science
Winston-Salem, North Carolina, 27157

Other trials in United States

Canada6 sites

Centre d'études cliniques CIUSS SLJ, Hôpital Chicoutimi
Chicoutimi, Quebec, G7H 5H6
CIUSSSS de l'Est-de-l'Ile-de-Montréal, Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X2P1
Jewish General Hospital
Montreal, Quebec, H3T 1E2
McGill University Health Centre
Montreal, Quebec, H4A 3J1
CISSS Des Laurentides
Saint-Jérôme, Quebec, J7Z 5T3

Other trials in Canada

About this study

Official title: RESOLUTION: A Double-blind, Randomized, Placebo-controlled, Phase II/III Study of the Efficacy and Safety of LAU-7b in the Treatment of Adult Hospitalized Patients With COVID-19 Disease

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.

Read the detailed description

RESOLUTION is a multicenter, randomized, double-blind, placebo-controlled Phase 2/3 study of LAU-7b for the treatment of COVID-19 Disease in participants at a higher risk than the general COVID-19 Disease population to develop complications while hospitalized.

The goal of the study is to evaluate the efficacy of LAU-7b therapy + standard-of-care relative to placebo + standard-of-care in participants with COVID-19 Disease with confirmed SARS-CoV-2 infection. SARS is "severe acute respiratory syndrome". CoV is " Coronavirus".

The purpose of the treatment with LAU-7b is to prevent the worsening of the health of hospitalized participants including aggravation such as recourse to mechanical ventilation and death.

The means are the direct effects of LAU-7b on the resolution of inflammation, interference with viral proliferation and protection from excessive pro-inflammatory response.

Conditions: COVID-19 Disease
Being tested: LAU-7b, Placebo oral capsule
Keywords: Inflammation, Antiviral, Host-directed treatment, Docosahexaenoic acid, Pro-resolving
Medical subject headings: Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LAU-7bDrug
Also called fenretinide
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.
Placebo oral capsuleDrug
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.

Study groups in NCT04417257
Study group	Role	What they receive
LAU-7b	Experimental	Active drug as LAU-7b capsules Receives: Drug: LAU-7b
Placebo	Placebo comparator	Placebo oral capsule (as inactive capsules identical to active arm) Receives: Drug: Placebo oral capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: By Day 60

Secondary outcomes (22)

The Safety of LAU-7b Therapy, Overview.
This will be assessed through monitoring of treatment emergent adverse events and serious adverse events, vital signs including oxygen saturation and body temperature, symptom-directed physical examinations and safety laboratory tests.
Measured: 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
This will be assessed through monitoring of treatment emergent adverse events and serious adverse events, vital signs including oxygen saturation and body temperature, symptom-directed physical examinations and safety laboratory tests.
Measured: 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.
The health status was graded using the World Health Organization 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
Measured: 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
This was assessed with Day 29 (and Day 60, presented separately) Health Status grading using the World Health Organization 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
Measured: 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
This was assessed with Day 29 (and Day 60, presented separately) Health Status grading using the World Health Organization 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
Measured: On Day 29
For Phase 2 Portion: Rate of All-causes Death By Day 60, Depicted by a Change From Baseline in the Ordinal Scale Score to Category 7
This was assessed with Day 60 (and Day 29, presented separately) Health Status grading using the World Health Organization 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
Measured: On Day 60
For Phase 3 Portion: Rate of All-causes Death By Day 60, Depicted by a Change From Baseline in the Ordinal Scale Score to Category 7
This was assessed with Day 60 (and Day 29, presented separately) Health Status grading using the World Health Organization 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
Measured: On Day 60
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
Measured: Day 29
For Phase 2 Portion: Rate of COVID-19 Disease-related Aggravation, Depicted by a Change From Baseline in the Ordinal Scale Score of at Least One Category
This was assessed through daily health status scoring using the World Health Organization 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
Measured: From baseline to Day 60
For Phase 3 Portion: Rate of COVID-19 Disease-related Aggravation, Depicted by a Change From Baseline in the Ordinal Scale Score of at Least One Category
This was assessed through daily health status scoring using the World Health Organization 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
Measured: From baseline to Day 60
For Phase 2 Only: Rate of COVID-19 Disease-related Transfer to Intensive Care Unit, Depicted by a Change From Baseline in the Ordinal Scale Score to Categories 5 or 6.
This was assessed through daily health status scoring using the World Health Organization 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
Measured: From baseline to Day 60
For Phase 2 Only: Rate of COVID-19 Disease-related Transfer to Mechanical Ventilation, Depicted by a Change From Baseline in the Ordinal Scale Score to Category 6
This was assessed through daily health status scoring using the World Health Organization 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
Measured: From baseline to Day 60
For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time.
This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score.
Outcome measure data are counts of participants with a given change from baseline in number of categories, by treatment group.
The mean change from baseline is compared between treatment groups.
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
Measured: From baseline to Day 60
For Phase 2 Only: Time to a Participant's Improvement of at Least One Category on the Ordinal Scale Health Status.
This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score.
If health status was not improved (remains stable or aggravates) by Day 60, it was censored at Day 60.
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
Measured: From baseline to Day 60
For Phase 2 Portion: Time to Recovery, Defined as the Time to Reach Categories 2 or 1 on the Ordinal Scale Participant Health Status (First Occurrence if More Than Once).
This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score.
If health status did not reach categories 2 or 1 by Day 60, it was censored at Day 60.
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
Measured: From baseline to Day 60
For Phase 3 Portion: Time to Recovery, Defined as the Time to Reach Categories 2 or 1 on the Ordinal Scale Participant Health Status (First Occurrence if More Than Once).
This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score.
If health status did not reach categories 2 or 1 by Day 60, it was censored at Day 60.
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
Measured: From baseline to Day 60
For Phase 2 Only: Time to Mechanical Ventilation, Defined Here as Time to Reach Category 6 on the Ordinal Scale Participant Health Status.
This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score.
If category 6 was skipped and the subject died (category 7), it was considered an event.
Subjects with missing observations were censored at their last available assessment if they did not need mechanical ventilation while on study.
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
Measured: From baseline to Day 60
For Phase 2 Only: Time to Death, Defined Here as a Time to Reach Category 7 on the Ordinal Scale Participant Health Status, Censored to Day 60 if it Happens Later Than Day 60
This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score.
It was censored to Day 60 if it happened later than Day 60, or at the last available visit where the subject was alive if no further ordinal scale health status.
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
Measured: From baseline to Day 60
For Phase 2 Portion: Duration of Hospitalization (Days) Within the Study Period Days 1-60
Monitoring of the hospitalization. In case of re-hospitalization within Day 60 for a given participant, the additional hospitalization time was included. Hospitalization for more than 60 days was considered 60 days in the calculation.
Measured: From baseline to Day 60
For Phase 3 Portion: Duration of Hospitalization (Days) Within the Study Period Days 1-60
Monitoring of the hospitalization. In case of re-hospitalization within Day 60 for a given participant, the additional hospitalization time was included. Hospitalization for more than 60 days was considered 60 days in the calculation.
Measured: From baseline to Day 60
For Phase 2 Only: Time to Attain an Undetectable Viral Load in Oropharyngeal Swabs.
Intent was to compare median time to undetectable viral load between treatment groups, through oropharyngeal swabs done at specified times while hospitalized. However, almost all sites were unable to obtain serial samples until discharge of participants. Therefore, with only a handful of results (reported herein), it was not possible to estimate the time to undetectable viral load.
Measured: Until discharge of participants, up to Day 60
The Change From Baseline in the Score Obtained on the EuroQol Five-dimensions Five-level (EQ-5D-5L) Quality-of-life Survey
This will be assessed in person or remotely, in participants reaching Days 14, 29, 45 and 60 and able to fill the questionnaire. EQ-5D-5L value was calculated based on the EQ-5D-5L user guide, and a higher value indicated better health status. The upper anchor point, full health, was 1.0 and the minimum value was 0.0.
Measured: On Days 1, 14, 29, 45 and 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Aug 202030 May 2024

First posted4 Jun 2020
Study start18 Aug 2020
Primary completion15 Feb 2024
Study completion30 May 2024

Why it stopped: Phase 2 completed normally, Phase 3 terminated for futility due to lack of aggravation events.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COVID-19 DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Double-blind, randomized, parallel groups and placebo-controlled trial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 351 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04417257
Sponsor's protocol ID: LAU-20-01
Acronym: RESOLUTION
Status last verified: Oct 2025
First submitted: 28 May 2020
Last updated: 13 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: RESOLUTION: A Double-blind, Randomized, Placebo-controlled, Phase II/III Study of the Efficacy and Safety of LAU-7b in the Treatment of Adult Hospitalized Patients With COVID-19 Disease
ClinicalTrials.gov ID: NCT04417257
Acronym / sponsor ID: RESOLUTION / LAU-20-01
Conditions: COVID-19 Disease
Keywords: Inflammation, Antiviral, Host-directed treatment, Docosahexaenoic acid, Pro-resolving
Phase: Phase 2/3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Phase 2 completed normally, Phase 3 terminated for futility due to lack of aggravation events.
Enrolment: 351 participants (actual)
Lead sponsor: Laurent Pharmaceuticals Inc.Industry (pharma, biotech, devices)
Study start: 18 Aug 2020 (actual)
Primary completion: 15 Feb 2024 (actual)
Study completion: 30 May 2024 (actual)
First posted: 4 Jun 2020 (actual)
Results: Posted 13 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

The purpose of the treatment with LAU-7b is to prevent the worsening of the health of hospitalized participants including aggravation such as recourse to mechanical ventilation and death.

The means are the direct effects of LAU-7b on the resolution of inflammation, interference with viral proliferation and protection from excessive pro-inflammatory response.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Double-blind, randomized, parallel groups and placebo-controlled trial

Arm	Type	Receives
LAU-7b	Experimental	Drug: LAU-7bActive drug as LAU-7b capsules
Placebo	Placebo comparator	Drug: Placebo oral capsulePlacebo oral capsule (as inactive capsules identical to active arm)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

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:
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

Key exclusion criteria (12 listed)

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:
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)]

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LAU-7bAlso: fenretinideLAU-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.	Drug	LAU-7b
Placebo oral capsulePlacebo will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.	Drug	Placebo

Primary outcome

Primary Outcome for Phase 2: Proportion of Participants Alive and Free of Respiratory Failure by Day 29 (Ordinal Scale Scores 1-4, Inclusively)
Time frame: On Day 29
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
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)
Time frame: By Day 60
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

22 secondary outcomes

The Safety of LAU-7b Therapy, Overview.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: On Day 29
For Phase 2 Portion: Rate of All-causes Death By Day 60, Depicted by a Change From Baseline in the Ordinal Scale Score to Category 7
Time frame: On Day 60
For Phase 3 Portion: Rate of All-causes Death By Day 60, Depicted by a Change From Baseline in the Ordinal Scale Score to Category 7
Time frame: On Day 60
Proportion of Participants Alive and Free of Respiratory Failure by Day 29 (Ordinal Scale Scores 1-4, Inclusively)
Time frame: Day 29
For Phase 2 Portion: Rate of COVID-19 Disease-related Aggravation, Depicted by a Change From Baseline in the Ordinal Scale Score of at Least One Category
Time frame: From baseline to Day 60
For Phase 3 Portion: Rate of COVID-19 Disease-related Aggravation, Depicted by a Change From Baseline in the Ordinal Scale Score of at Least One Category
Time frame: From baseline to Day 60
For Phase 2 Only: Rate of COVID-19 Disease-related Transfer to Intensive Care Unit, Depicted by a Change From Baseline in the Ordinal Scale Score to Categories 5 or 6.
Time frame: From baseline to Day 60
For Phase 2 Only: Rate of COVID-19 Disease-related Transfer to Mechanical Ventilation, Depicted by a Change From Baseline in the Ordinal Scale Score to Category 6
Time frame: From baseline to Day 60
For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time.
Time frame: From baseline to Day 60
For Phase 2 Only: Time to a Participant's Improvement of at Least One Category on the Ordinal Scale Health Status.
Time frame: From baseline to Day 60
For Phase 2 Portion: Time to Recovery, Defined as the Time to Reach Categories 2 or 1 on the Ordinal Scale Participant Health Status (First Occurrence if More Than Once).
Time frame: From baseline to Day 60
For Phase 3 Portion: Time to Recovery, Defined as the Time to Reach Categories 2 or 1 on the Ordinal Scale Participant Health Status (First Occurrence if More Than Once).
Time frame: From baseline to Day 60
For Phase 2 Only: Time to Mechanical Ventilation, Defined Here as Time to Reach Category 6 on the Ordinal Scale Participant Health Status.
Time frame: From baseline to Day 60
For Phase 2 Only: Time to Death, Defined Here as a Time to Reach Category 7 on the Ordinal Scale Participant Health Status, Censored to Day 60 if it Happens Later Than Day 60
Time frame: From baseline to Day 60
For Phase 2 Portion: Duration of Hospitalization (Days) Within the Study Period Days 1-60
Time frame: From baseline to Day 60
For Phase 3 Portion: Duration of Hospitalization (Days) Within the Study Period Days 1-60
Time frame: From baseline to Day 60
For Phase 2 Only: Time to Attain an Undetectable Viral Load in Oropharyngeal Swabs.
Time frame: Until discharge of participants, up to Day 60
The Change From Baseline in the Score Obtained on the EuroQol Five-dimensions Five-level (EQ-5D-5L) Quality-of-life Survey
Time frame: On Days 1, 14, 29, 45 and 60

Results and safety

Results posted to the registry on 13 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LAU-7b	117	89
Placebo	115	91

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

Time frame: On Day 29. Count of participants. Unit: Participants

Measure	LAU-7b Phase 2 n = 117	Placebo Phase 2 n = 115
ITT population, alive and free of respiratory failure. Missing data as failure.	81	83
Per-Protocol Population, alive and free of respiratory failure, no imputation	65	65
Health Status 3 + 4 at baseline alive and free of respiratory failure. Missing data as failure.	60	54
Health Status 5 at baseline alive and free of respiratory failure. Missing data as failure.	21	29
Health Status 3 + 4 at baseline with Day 29 data (no imputation)	60	54

LAU-7b Phase 2 vs Placebo Phase 2: Mean Difference (Final Values): -2.9 (95% CI -15 to 9), p = 0.7377, Fisher Exact
LAU-7b Phase 2 vs Placebo Phase 2: Mean Difference (Final Values): -3.0 (95% CI -10.0 to 2.8), p = 1.000, Fisher Exact
LAU-7b Phase 2 vs Placebo Phase 2: Odds Ratio (OR): 0.570 (95% CI 0.359 to 0.907), p = 0.0177, Regression, Logistic

Population analysed: ITT population (received a minimum of one study treatment dose), per-protocol (PP) population (received a minimum of 12 days of study treatment and no major protocol deviation)

Primary outcome: 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)

Time frame: By Day 60. Count of participants. Unit: Participants

Measure	LAU-7b Phase 3 n = 57	Placebo Phase 3 n = 62
ITT population with Day 60 data (no imputation)	3	2
Per-Protocol Population, alive and free of respiratory failure, no imputation	2	2

LAU-7b Phase 3 vs Placebo Phase 3: Mean Difference (Net): 2.7 (95% CI -6.9 to 13.9), p = 0.6600, Fisher Exact
LAU-7b Phase 3 vs Placebo Phase 3: Mean Difference (Net): 0.5 (95% CI -10.6 to 12.6), p = 1.000, Fisher Exact

Population analysed: ITT population (received a minimum of one study treatment dose), per-protocol (PP) population (received a minimum of 12 days of study treatment and no major protocol deviation)

22 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of informed consent until the End-of-Study follow-up on Day 60, or until early termination or death, whichever occurred first.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LAU-7b Phase 2	23 of 117 (19.7%)	97 of 117 (82.9%)	14 of 117
Placebo Phase 2	22 of 115 (19.1%)	94 of 115 (81.7%)	11 of 115
LAU-7b Phase 3	12 of 57 (21.1%)	45 of 57 (78.9%)	3 of 57
Placebo Phase 3	13 of 62 (21%)	54 of 62 (87.1%)	1 of 62

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jean-Marie Houle, PhD study director

Laurent Pharmaceuticals Inc.

29 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing LAU-7b in people with COVID-19 Disease, run by Laurent Pharmaceuticals Inc. at 29 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome for Phase 2: Proportion of Participants Alive and Free of Respiratory Failure by Day 29 (Ordinal Scale Scores 1-4, Inclusively) (time frame: On Day 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04417257.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.