Peginterferon lambda for the treatment of outpatients with COVID-19: a phase 2, placebo-controlled randomised trial.
description: To date, only monoclonal antibodies have been shown to be effective for outpatients with COVID-19. Interferon lambda-1 is a type III interferon involved in innate antiviral responses with activity against respiratory pathogens. We aimed to investigate the safety and efficacy of peginterferon lambda in the treatment of outpatients with mild-to-moderate COVID-19. In this double-blind, placebo-controlled trial, outpatients with laboratory-confirmed COVID-19 were randomly assigned to a single subcutaneous injection of peginterferon lambda 180 μg or placebo within 7 days of symptom onset or first positive swab if asymptomatic. Participants were randomly assigned (1:1) using a computer-generated randomisation list created with a randomisation schedule in blocks of four. At the time of administration, study nurses received a sealed opaque envelope with the treatment allocation number. The primary endpoint was the proportion of patients who were negative for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA on day 7 after the injection, analysed by a χ2 test following an intention-to-treat principle. Prespecified analysis of the primary endpoint, adjusted for baseline viral load, using bivariate logistic regression was done. The trial is now complete. This trial is registered with ClinicalTrials.gov, NCT04354259. Between May 18, and Sept 4, 2020, we recruited 30 patients per group. The decline in SARS-CoV-2 RNA was greater in those treated with peginterferon lambda than placebo from day 3 onwards, with a difference of 2·42 log copies per mL at day 7 (p=0·0041). By day 7, 24 (80%) participants in the peginterferon lambda group had an undetectable viral load, compared with 19 (63%) in the placebo group (p=0·15). After controlling for baseline viral load, patients in the peginterferon lambda group were more likely to have undetectable virus by day 7 than were those in the placebo group (odds ratio [OR] 4·12 [95% CI 1·15-16·73; p=0·029). Of those with baseline vi…
creator: Jordan J Feld, Christopher Kandel, Mia J Biondi, Robert A Kozak, Muhammad Atif Zahoor, Camille Lemieux, Sergio M Borgia, Andrea K Boggild, Jeff Powis, Janine McCready, Darrell H S Tan, Tiffany Chan, Bryan Coburn, Deepali Kumar, Atul Humar, Adrienne Chan, Braden O'Neil, Seham Noureldin, Joshua Booth, Rachel Hong, David Smookler, Wesam Aleyadeh, Anjali Patel, Bethany Barber, Julia Casey, Ryan Hiebert, Henna Mistry, Ingrid Choong, Colin Hislop, Deanna M Santer, D Lorne Tyrrell, Jeffrey S Glenn, Adam J Gehring, Harry L A Janssen, Bettina E Hansen
source: The Lancet. Respiratory medicine
date: 2021