Covid19, Post-acute COVID-19 Respiratory Disease
Conditions
Keywords
COVID-19 Respiratory Disease, novel coronavirus, respiratory complications, SARS-CoV-2, post acute, lung fibrosis, interstitial lung disease, long COVID, long haul COVID, Post-acute COVID-19 Respiratory Disease
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.
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.
Interventions
DRUGLYT-100
oral administration
OTHERPlacebo
oral administration
Sponsors
PureTech
Clinipace Worldwide
Novotech (Australia) Pty Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Distance Walked During the Six-Minute Walk Test (6MWT) | Baseline to Day 91 | The 6MWT is a validated endpoint commonly used in clinical trial research. The 6MWT measures the distance a subject can quickly walk on a flat, hard surface in a period of 6 minutes. It evaluates the global and integrated response of all the systems involved during exercise. |
Countries
Argentina, Brazil, Moldova, Philippines, Romania, Ukraine, United Kingdom, United States
Contacts
PRINCIPAL_INVESTIGATORToby Maher, MD
Keck School of Medicine, University of Southern California
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 52.7 years STANDARD_DEVIATION 12.49 |
| Age, Customized <65 years | 136 Participants |
| Age, Customized >=65 years | 41 Participants |
| BMI | 30.05 kg/m^2 STANDARD_DEVIATION 4.71 |
| Days since discharge from hospital | 34.2 days STANDARD_DEVIATION 29.11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 158 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Height | 169.24 cm STANDARD_DEVIATION 10.178 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 20 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 79 Participants |
| Region of Enrollment Argentina | 8 participants |
| Region of Enrollment Brazil | 2 participants |
| Region of Enrollment Moldova | 22 participants |
| Region of Enrollment Philippines | 8 participants |
| Region of Enrollment Romania | 25 participants |
| Region of Enrollment Ukraine | 20 participants |
| Region of Enrollment United Kingdom | 5 participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 50 Participants |
| Time from COVID diagnosis to first dose of study drug | 56.3 days STANDARD_DEVIATION 28.16 |
| Weight | 87.82 kg STANDARD_DEVIATION 16.99 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 90 | 0 / 95 | 0 / 107 |
| other Total, other adverse events | 19 / 90 | 52 / 95 | 41 / 107 |
| serious Total, serious adverse events | 3 / 90 | 3 / 95 | 4 / 107 |
Outcome results
None listed