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

October 29, 2025 updated by: Laurent Pharmaceuticals Inc.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

351

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Centre d'études cliniques CIUSS SLJ, Hôpital Chicoutimi
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre
      • Montreal, Quebec, Canada, H1T 2M4
        • CIUSSSS de l'Est-de-l'Ile-de-Montréal, Hôpital Maisonneuve-Rosemont
      • Montreal, Quebec, Canada, H2X2P1
        • Centre Hospitalier de l'Universite de Montreal
      • Saint-Jérôme, Quebec, Canada, J7Z 5T3
        • CISSS des Laurentides
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Chandler Regional Medical Center / Mercy Gilbert Medical Center
    • California
      • Newport Beach, California, United States, 92663
        • Hoag Memorial Hospital Presbyterian
      • Sacramento, California, United States, 95817
        • University of California Davis Medical Center
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Nuvance Health - Danbury Hospital
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Medstar Washington Hospital Center
    • Florida
      • Jacksonville Beach, Florida, United States, 32250
        • Baptist Medical Center Beaches
    • Idaho
      • Boise, Idaho, United States, 83702
        • St Lukes Hospital
    • Illinois
      • Chicago, Illinois, United States, 60625
        • NorthShore University Health System - Swedish Hospital
      • Glenview, Illinois, United States, 60026
        • NorthShore University Health System - Glenbrook Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Anne Arundel Medical Center, 2001 Medical Parkway, Belcher Pavillion
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Detroit, Michigan, United States, 48201
        • Wayne State University, Harper University Hospital and Detroit Receiving Hospital
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • University Medical Center of Southern Nevada
    • New York
      • Staten Island, New York, United States, 10305
        • Staten Island University Hospital North
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Science
    • Ohio
      • Columbus, Ohio, United States, 43214
        • OhioHealth Riverside Methodist Hospital
      • Kettering, Ohio, United States, 45429
        • Kettering Health
    • Pennsylvania
      • Sayre, Pennsylvania, United States, 18840
        • Robert Packer Hospital
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • Mesquite, Texas, United States, 75149
        • PRX Research /Dallas Regional Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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]

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LAU-7b
Active drug as LAU-7b capsules
Drug: LAU-7b
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.
Other Names:
  • fenretinide
Placebo Comparator: Placebo
Placebo oral capsule (as inactive capsules identical to active arm)
Drug: Placebo oral capsule
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
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
By Day 60

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Safety of LAU-7b Therapy, Overview.
Time Frame: From baseline to Day 60
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.
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
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.
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

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
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

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
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

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
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

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
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

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
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

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
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

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
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

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
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

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
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

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
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

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
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

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
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

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
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

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
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

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
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

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
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
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.
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
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.
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
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.
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
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.
On Days 1, 14, 29, 45 and 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laurent Pharmaceuticals Inc.

Investigators

  • Study Director: Jean-Marie Houle, PhD, Laurent Pharmaceuticals Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2020

Primary Completion (Actual)

February 15, 2024

Study Completion (Actual)

May 30, 2024

Study Registration Dates

First Submitted

May 28, 2020

First Submitted That Met QC Criteria

June 3, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Estimated)

November 13, 2025

Last Update Submitted That Met QC Criteria

October 29, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAU-20-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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