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LYT-100 in Post-acute COVID-19 Respiratory Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04652518
Recruitment Status : Recruiting
First Posted : December 3, 2020
Last Update Posted : February 26, 2021
Sponsor:
Collaborators:
Clinipace Worldwide
Novotech (Australia) Pty Limited
Information provided by (Responsible Party):
PureTech

Brief Summary:
This study is a randomized, double-blind, parallel arm study to evaluate the safety and efficacy of LYT-100 compared to placebo in adults with post-acute COVID-19 respiratory complications

Condition or disease Intervention/treatment Phase
Covid19 Drug: LYT-100 Other: Placebo Phase 2

Detailed Description:
This study is a randomized, double-blind, parallel arm study being conducted at up to 20 centers globally to evaluate the safety and efficacy of LYT-100 compared to placebo in 168 adults with post-acute COVID-19 respiratory complications who were treated with, but no longer require mechanical ventilation, extracorporeal membrane oxygenation, non-invasive ventilation (eg CPAP or BiPAP), high-flow nasal oxygen therapy, or combination thereof. LYT-100 or placebo will be taken daily for up to 91 days with the primary outcome of change in distance walked on the six-minute walk test performed in line with the American Thoracic Society Respiratory Society Guidelines assessed at Day 91. Secondary endpoints, including pharmacokinetics, inflammatory biomarkers, imaging, and patient-reported outcomes of dyspnea and the 36-Item Short Form Health Survey will also be evaluated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Double-blind, Placebo-controlled Safety and Efficacy Trial of Deupirfenidone (LYT-100) in Post-acute COVID-19 Respiratory Disease
Actual Study Start Date : December 11, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: LYT-100
LYT-100 taken orally BID for 91 days
Drug: LYT-100
oral administration
Other Name: Deupirfenidone

Placebo Comparator: Placebo
Placebo matching LYT-100 taken orally BID for 91 days
Other: Placebo
oral administration




Primary Outcome Measures :
  1. Change in distance walked on the six-minute walk test (6MWT) [ Time Frame: Baseline to Day 91 ]
    The 6MWT is a validated endpoint commonly used in clinical trial research


Secondary Outcome Measures :
  1. Change in Modified Borg Dyspnoea Scale (mBDS) score [ Time Frame: Baseline to Day 91 ]
    The mBDS is an assessment tool that analyzes breathlessness under exertion

  2. Quality of Life assessment as collected using the SF-36 [ Time Frame: Baseline to Day 91 ]
    The SF-36 (v2) is a self-administered questionnaire containing 36 items that measures functional status, well-being and overall evaluation of health in 8 domains



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Hospitalization for COVID-19 respiratory disease (with positive result of a molecular RT-qPCR diagnostic test or SARS-CoV-2 RNA result) for at least 1-day within the last 42 days prior to screening, and requiring at least one of the listed treatment modalities: MV, ECMO, NIV, HFNO during hospitalization
  • COVID-19 pneumonia findings on imaging (chest X-ray or CT Scan) with a minimum of two lung lobes involvement
  • Able to bear weight and ambulate a minimum of 10 m distance (use of inhaled oxygen permitted)
  • Shortness of breath ≥ grade 3 on mBDS dyspnea scale and not requiring MV, ECMO, NIV, and/or HFNO (nasal O2 is allowed) for at least 72 hours before screening

Key Exclusion Criteria:

  • Pre-existing chronic respiratory condition(s), obstructive or restrictive, for which the patient is actively taking concomitant medication are excluded. Patients with history of Idiopathic Pulmonary Fibrosis (IPF), lung cancer, pulmonary arterial hypertension, other interstitial lung diseases, severe cardiac insufficiency (grade IV) are excluded irrespective of whether they are actively being medicated for those conditions or not.
  • Pre-existing co-morbid conditions preventing outcome assessments, e.g., neurological, medical, orthopedic injury/disability, disease or condition that would prevent ability to transfer and walk for 6 minutes, prior to confirmed COVID-19 diagnosis
  • Unstable angina or myocardial infarction in the last month prior to screening
  • Patients on MV, ECMO, NIV, and/or HFNO within the last 72 hours prior to screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04652518


Contacts
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Contact: Heather Paden 617-226-4813 lyt100clinical@puretechhealth.com

Locations
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United States, California
University of Southern California - Keck School of Medicine Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Study Coordinator    323-409-5383      
Principal Investigator: Toby Maher, MD, PhD         
United States, Florida
Central Florida Pulmonary Group Not yet recruiting
Orlando, Florida, United States, 32803
Contact: Study Coordinator    407-841-1100      
Principal Investigator: Syed Mobin, MD, FCCP         
United States, North Carolina
Southeastern Research Center Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Site Coordinator    336-659-8414      
Principal Investigator: Barry Sigal, MD, FCCP         
United States, Texas
Site Coordinator Recruiting
Austin, Texas, United States, 78763
Contact: Site Coordinator    512-459-0301      
Principal Investigator: Jack Bissett, MD         
Romania
Institutul de Pneumoftiziologie "Marius Nasta" ("Marius Nasta" Pneumoftiziology Institute) Not yet recruiting
Bucharest, Romania, 050159
Contact: Study Coordinator    +40 (0) 21-335-69-10      
Principal Investigator: Florin Dumitru Milhatan, MD, PhD, FCCP         
National Institute for Infectious Diseases "Prof. Dr. Matei Balş" (Arensia Eploratory Medicine) Recruiting
Bucharest, Romania
Contact: Site Coordinator         
Contact    +40 (0) 21-201-09-80      
Principal Investigator: Adrian Streinu-Cercel, MD, PhD         
Spitalul Clinic De Pneumoftiziologie "Leon Daniello" Cluj-Napoca Recruiting
Cluj-Napoca, Romania, 400332
Contact: Study Coordinator         
Contact    +40 (0) 743 434 360      
Principal Investigator: Milena Adina Man, MD, PhD         
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes Craiova Recruiting
Craiova, Romania, 200515
Contact: Study Coordinator    +40 (0) 372-273-665      
Principal Investigator: Mihai Olteanu, MD         
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes - Timisoara Recruiting
Timişoara, Romania, 300310
Contact: Study Coordinator    +40 (0) 256-20-76-70      
Principal Investigator: Monica Marc, MD, PhD         
Sponsors and Collaborators
PureTech
Clinipace Worldwide
Novotech (Australia) Pty Limited
Investigators
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Principal Investigator: Toby Maher, MD Keck School of Medicine, University of Southern California
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Responsible Party: PureTech
ClinicalTrials.gov Identifier: NCT04652518    
Other Study ID Numbers: LYT-100-2020-02
First Posted: December 3, 2020    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PureTech:
COVID-19 Respiratory Disease
novel coronavirus
respiratory complications
SARS-CoV-2
post acute
lung fibrosis
interstitial lung disease
long COVID
long haul COVID
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases