Covid19Phase 2NCT04652518
LYT-100 in Post-acute COVID-19 Respiratory Disease
A Phase 2 study testing LYT-100 in people with Covid19 and Post-acute COVID-19 Respiratory Disease, run by PureTech at 31 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19, Post-acute COVID-19 Respiratory Disease
- What is being tested?
- LYT-100
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 185 participants
- Where
- 31 sitesin 8 countries
- Study dates
- 11 Dec 2020to 18 Jul 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
31 sites in 8 countries.
31 sites in 8 countries
United States15 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
GenHarp Clinical Solutions
Evergreen Park, Illinois, 60805
North Alabama Medical Center
Florence, Alabama, 35630
Center for Advanced Research and Education
Gainesville, Georgia, 30501
Frostwood Family Medicine
Houston, Texas, 77024
University of Southern California - Keck School of Medicine
Los Angeles, California, 90033
Vista Health Research
Miami, Florida, 33176
Circuit Clinical/Crystal Run Healthcare LLP
Middletown, New York, 10941
Affinity Health Corp
Nashville, Tennessee, 37203
Central Florida Pulmonary Group
Orlando, Florida, 32803
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, 15213
The University of Texas Health Sciences Center at San Antonio
San Antonio, Texas, 78229
Coastal Pulmonary and Critical Care
St. Petersburg, Florida, 33704
Tampa General Hospital
Tampa, Florida, 33606
Southeastern Research Center
Winston-Salem, North Carolina, 27103
Romania4 sites
National Institute for Infectious Diseases "Prof. Dr. Matei Balş" (Arensia Eploratory Medicine)
Bucharest
Spitalul Clinic De Pneumoftiziologie "Leon Daniello" Cluj-Napoca
Cluj-Napoca, 400332
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes Craiova
Craiova, 200515
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes - Timisoara
Timișoara, 300310
Argentina3 sites
Fundacion Estudios Clinicos
Rosario, Santa Fe Province, 2000
Investigaciones en Patologias Respiratorias
San Miguel de Tucumán, Tucumán Province, 4000
Clinica Central S.A
Villa Regina, Río Negro Province, 8336
Brazil3 sites
CETI - Centro de Estudos em Terapias Inovadoras
Curitiba, Paraná, 80030-110
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Instituto de Doencas do Torax
Rio de Janeiro, 21941-913
Philippines2 sites
University of the Philippines Manila - Philippine General Hospital (PGH)
Manila, 1000
Quirino Memorial Medical Center (QMMC)
Quezon City, 1109
United Kingdom2 sites
Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital
London, SE1 9RT
St George's University Hospitals NHS Foundation Trust - St George's Hospital
London, SW17 0QT
Ukraine1 site
Medical Center of Limited Liability Company "Harmoniya krasy"
Kiev, 01135
About this study
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
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.
Read the 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.
- Conditions
- Covid19, Post-acute COVID-19 Respiratory Disease
- Being tested
- LYT-100, Placebo
- 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
- Medical subject headings
- COVID-19, Pulmonary Fibrosis, Lung Diseases, Interstitial, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LYT-100Drug
Also called Deupirfenidone
oral administration
PlaceboOther
oral administration
| Study group | Role | What they receive |
|---|---|---|
| LYT-100 | Experimental | LYT-100 taken orally twice a day (BID) for 91 days Receives: Drug: LYT-100 |
| Placebo | Placebo comparator | Placebo matching LYT-100 taken orally BID for 91 days Receives: Other: Placebo |
| Open Label Extension LYT-100 | Other | Open Label Extension: LYT-100 taken orally BID for 91 days The Open Label Extension (Part B) was terminated after results of the Double Blind Portion. Receives: Drug: LYT-100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Distance Walked During the Six-Minute Walk Test (6MWT)
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.
Measured: Baseline to Day 91
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start11 Dec 2020
- Primary completion28 Jun 2022
- Study completion18 Jul 2022
Why it stopped: Part A of the study was completed; Part B of the study was terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- PureTech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinipace Worldwide, Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
- Investigators
- Toby Maher, MD, Principal investigator, Keck School of Medicine, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652518
- Sponsor's protocol ID
- LYT-100-2020-02
- Status last verified
- May 2026
- First submitted
- 2 Dec 2020
- Last updated
- 23 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kulkarni T, Santiaguel J, Aul R, Harnett M, Krop J, Chen MC, Graham CS, Maher TM. Deupirfenidone (LYT-100) in post-acute sequelae of SARS-CoV-2 with respiratory complications. ERJ Open Res. 2025 Jul 21;11(4):01142-2024. doi: 10.1183/23120541.01142-2024. eCollection 2025 Jul.
PubMed 40692836
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04652518
- Acronym / sponsor ID
- LYT-100-2020-02
- Conditions
- Covid19, Post-acute COVID-19 Respiratory Disease
- Keywords
- COVID-19 Respiratory Disease, novel coronavirus, respiratory complications, SARS-CoV-2, post acute, lung fibrosis, interstitial lung disease, long COVID
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Part A of the study was completed; Part B of the study was terminated
- Enrolment
- 185 participants (actual)
- Lead sponsor
- PureTechIndustry (pharma, biotech, devices)
- Collaborators
- Clinipace Worldwide, Novotech (Australia) Pty Limited
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 18 Jul 2022 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Posted 23 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LYT-100 | Experimental | Drug: LYT-100LYT-100 taken orally twice a day (BID) for 91 days |
| Placebo | Placebo comparator | Other: PlaceboPlacebo matching LYT-100 taken orally BID for 91 days |
| Open Label Extension LYT-100 | Other | Drug: LYT-100Open Label Extension: LYT-100 taken orally BID for 91 days The Open Label Extension (Part B) was terminated after results of the Double Blind Portion. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LYT-100Also: Deupirfenidoneoral administration | Drug | LYT-100, Open Label Extension LYT-100 |
| Placebooral administration | Other | Placebo |
Primary outcome
Change From Baseline in Distance Walked During the Six-Minute Walk Test (6MWT)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40692836Kulkarni T, Santiaguel J, Aul R, Harnett M, Krop J, Chen MC, Graham CS, Maher TM. Deupirfenidone (LYT-100) in post-acute sequelae of SARS-CoV-2 with respiratory complications. ERJ Open Res. 2025 Jul 21;11(4):01142-2024. doi: 10.1183/23120541.01142-2024. eCollection 2025 Jul.
Related trials for Covid19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
RecruitingPhase 3
A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)
Coronavirus Disease (COVID-19)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toby Maher, MD principal investigator
Keck School of Medicine, University of Southern California
31 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LYT-100 in people with Covid19 and Post-acute COVID-19 Respiratory Disease, run by PureTech at 31 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Romania, Argentina, Brazil, Philippines and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Distance Walked During the Six-Minute Walk Test (6MWT) (time frame: Baseline to Day 91). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04652518, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.