RECLAIM
Research type
Research Study
Full 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
IRAS ID
287129
Contact name
Heather Paden
Contact email
Sponsor organisation
PureTech LYT 100, Inc.
Eudract number
2020-003210-13
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
151467, IND Number
Duration of Study in the UK
1 years, 4 months, 0 days
Research summary
COVID-19 is a respiratory infection caused by the SARS-CoV-2 virus. The aim of this study is to test the efficacy of a medicine called LYT-100 (Deupirfenidone) in patients with post-acute COVID-19 respiratory disease.
LYT-100 is a different form of pirfenidone, a drug that is approved for idiopathic pulmonary fibrosis (a chronic scarring lung disease). There is some evidence that scarring of the lungs occurs during COVID-19 infection and therefore LYT-100 is being investigated to see whether it can help people with COVID-19 lung infections with improved tolerability and efficacy compared with pirfenidone. This study will be the first time that patients with post-acute COVID-19 respiratory disease will receive LYT-100.
The study will last up to 113 days. This timeframe includes a screening period which will be followed by a study treatment period of up to 91 days, with off-treatment safety follow-up of 14 days.
This study will enroll adults aged 18 to 80 that have been diagnosed with post-acute COVID-19 respiratory disease. Their COVID-19 status will be confirmed with a positive RT-qPCR diagnostic test. Women of childbearing age can also participate in this study as long as contraceptive requirements are met during and post follow-up phases. Women of childbearing age who choose to participate into this trial must have a negative pregnancy test during screening and prior to study drug administration.
The study is a Phase II randomised double-blind placebo-controlled study. In other words, neither patient nor study doctor will know what substance is being prescribed. Each patient has a 50% chance of receiving active study drug or placebo. Patients will be asked to take 3 capsules twice a day with a gap of 10-12 hours.REC name
London - Chelsea Research Ethics Committee
REC reference
20/HRA/4623
Date of REC Opinion
25 Jan 2021
REC opinion
Further Information Favourable Opinion