LYT-100 in Post-acute COVID-19 Respiratory Disease
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|ClinicalTrials.gov Identifier: NCT04652518|
Recruitment Status : Completed
First Posted : December 3, 2020
Last Update Posted : March 1, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Covid19||Drug: LYT-100 Other: Placebo||Phase 2|
Part A of this study is a randomized, double-blind, parallel arm study being conducted at approximately 35 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 mechanical ventilation, extracorporeal membrane oxygenation, non-invasive ventilation (eg CPAP or BiPAP), high-flow nasal oxygen therapy or any other means of oxygen administration in the hospital for at least 1 day and have required only low flow nasal oxygen or no oxygen supplementation for at least 72 hours prior to screening. 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.
The second part of the study, Part B, is an open-label extension in which eligible patients who completed Part A will be enrolled and treated with open-label LYT-100 for an additional 91 days. The primary endpoint for Part B of the study is to assess the longer-term safety, tolerability, and efficacy of LYT-100 through up to 182 days of treatment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||185 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2 Randomized, Double-blind, Placebo-controlled Trial and Open Label Extension to Evaluate the Safety and Efficacy of Deupirfenidone (LYT-100) in Post-acute COVID-19 Respiratory Disease|
|Actual Study Start Date :||December 11, 2020|
|Actual Primary Completion Date :||June 28, 2022|
|Actual Study Completion Date :||July 18, 2022|
LYT-100 taken orally BID for 91 days
Other Name: Deupirfenidone
Placebo Comparator: Placebo
Placebo matching LYT-100 taken orally BID for 91 days
- 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
- Change in Dyspnoea-12 score [ Time Frame: Baseline to Day 91 ]Dyspnoea-12 measures "breathlessness severity" without reference to current activity and was developed for use in interstitial lung disease and COPD current experience ("these days.") The tool generates a total score using 12 descriptor items including seven physical and five affective items with response options none (0), mild (1), moderate (2) or severe (3). The total score ranges from 1 to 36 whereby the higher score correlates with greater breathlessness severity.
- Change in Saint George Respiratory Questionnaire-I (SGRQ-I) score [ Time Frame: Baseline to Day 91 ]Saint George Respiratory Questionnaire-I (SGRQ-I) is an idiopathic pulmonary fibrosis disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with interstitial lung disease. There are 34 self-completed items with 3 domain component scores (Symptoms, Activities, and Impacts), with higher scores indicating more limitations.
- 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. It starts at number 0 where breathing is causing no difficulty at all and progresses through to number 10 where breathing difficulty is maximal.
- 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|
Key Inclusion Criteria:
- Positive result of a molecular RT-qPCR diagnostic test or SARS-CoV-2 RNA result from a clinical specimen deemed clinically associated with the current episode of illness, warranting hospital admission as per investigator's judgement, or previously hospitalized (central and/or local laboratory COVID-19 test results are accepted from any biological material source)
- Hospitalization for COVID-19 respiratory disease and treated with supplemental oxygen (including MV, ECMO or any other means of oxygen administration) in hospital for at least 1 day
- 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
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
|Principal Investigator:||Toby Maher, MD||Keck School of Medicine, University of Southern California|
|Other Study ID Numbers:||
|First Posted:||December 3, 2020 Key Record Dates|
|Last Update Posted:||March 1, 2023|
|Last Verified:||February 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
COVID-19 Respiratory Disease
interstitial lung disease
long haul COVID
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal