NCT04652518

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: PureTech · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19
• Post-acute COVID-19 Respiratory Disease

Interventions

Type	Name	Description
DRUG	LYT-100	oral administration
OTHER	Placebo	oral administration

Timeline

• Start date: 2020-12-11
• Primary completion: 2022-06-28
• Completion: 2022-07-18
• First posted: 2020-12-03
• Last updated: 2024-02-14

Locations

31 sites across 8 countries: United States, Argentina, Brazil, Moldova, Philippines, Romania, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study