LYT-100 in Post-acute COVID-19 Respiratory Disease
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| ClinicalTrials.gov Identifier: NCT04652518 |
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Recruitment Status :
Recruiting
First Posted : December 3, 2020
Last Update Posted : February 26, 2021
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Sponsor:
PureTech
Collaborators:
Clinipace Worldwide
Novotech (Australia) Pty Limited
Information provided by (Responsible Party):
PureTech
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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 |
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.
| 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 |
|---|---|
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Experimental: LYT-100
LYT-100 taken orally BID for 91 days
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Drug: LYT-100
oral administration
Other Name: Deupirfenidone |
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Placebo Comparator: Placebo
Placebo matching LYT-100 taken orally BID for 91 days
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Other: Placebo
oral administration |
Primary Outcome Measures :
- 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 :
- 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
- 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
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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
| Contact: Heather Paden | 617-226-4813 | lyt100clinical@puretechhealth.com |
Locations
| 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
| Principal Investigator: | Toby Maher, MD | Keck School of Medicine, University of Southern California |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by PureTech:
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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 |