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

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ClinicalTrials.gov Identifier: NCT04652518
Recruitment Status : Recruiting
First Posted : December 3, 2020
Last Update Posted : July 27, 2021
Sponsor:
Collaborators:
Clinipace Worldwide
Novotech (Australia) Pty Limited
Information provided by (Responsible Party):
PureTech

Brief Summary:
This study is being conducted in two parts, A and B. Part A 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. Part B is an Open Label Extension (OLE) study for patients who complete Part A.

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

Detailed Description:

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.

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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 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
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:

  • 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

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 clinicaltrials@puretechhealth.com

Locations
Show Show 22 study locations
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: July 27, 2021
Last Verified: July 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