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0 0.5 1 1.5 2+ Hospitalization 0% Improvement Relative Risk ER visit 75% Viral clearance 66% Peg.. Lambda  Feld et al.  EARLY TREATMENT  DB RCT Is early treatment with peginterferon lambda beneficial for COVID-19? Double-blind RCT 60 patients in Canada (May - September 2020) Improved viral clearance with peginterferon lambda (p=0.029) Feld et al., The Lancet Respiratory Me.., Nov 2020 Favors peg.. lambda Favors control

Peginterferon lambda for the treatment of outpatients with COVID-19: a phase 2, placebo-controlled randomised trial

Feld et al., The Lancet Respiratory Medicine, doi:10.1016/S2213-2600(20)30566-X (date from preprint), NCT04354259
Nov 2020  
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Small outpatient RCT with 30 peginterferon lambda and 30 control patients, showing improved viral clearance with treatment. Single subcutaneous injection of peginterferon lambda 180μg. NCT04354259 (history).
risk of hospitalization, no change, RR 1.00, p = 1.00, treatment 1 of 30 (3.3%), control 1 of 30 (3.3%).
risk of ER visit, 75.0% lower, RR 0.25, p = 0.35, treatment 1 of 30 (3.3%), control 4 of 30 (13.3%), NNT 10.0.
risk of no viral clearance, 66.4% lower, RR 0.34, p = 0.03, treatment 6 of 30 (20.0%), control 11 of 30 (36.7%), NNT 6.0, inverted to make RR<1 favor treatment, odds ratio converted to relative risk, adjusted for baseline viral load, day 7.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Feld et al., 12 Nov 2020, Double Blind Randomized Controlled Trial, placebo-controlled, Canada, peer-reviewed, 35 authors, study period 18 May, 2020 - 4 September, 2020, average treatment delay 4.3 days, trial NCT04354259 (history).
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This PaperPeg.. LambdaAll
Peginterferon lambda for the treatment of outpatients with COVID-19: a phase 2, placebo-controlled randomised trial
MD Jordan J Feld, PhD Mia J Biondi, PhD Muhammad Atif Zahoor, S Noureldin, MSc J Booth, D Hong, PhD W Smookler, MD A Aleyadeh, B Barber RN J Patel, J Casey, PhD Gehring, B E Hansen L A Janssen, PhD), Toronto General Hospital, Multiorgan Transplant Centre (D Kumar E Hansen, Health Network (j J Feld, J Biondi, MD Camille Lemieux, MD Andrea K Boggild, MD B Coburn, R Hong, D Smookler, W Aleyadeh, A Patel, B Barber, Prof Adam J Gehring, PhD A Kozak, MD R Chan, H Hiebert, Michael Mistry, J Garron, MD Jeff Powis, MD St Mccready, D H S Michael's Hospital, MD Tan, North York General Hospital B O'neil, PhD Ingrid Choong, Christopher Kandel, Robert A Kozak, Sergio M Borgia, Janine Mccready, Henna Mistry, Colin Hislop, Deanna M Santer, Prof D Lorne Tyrrell, Jeffrey S Glenn, Harry L A Janssen, Bettina E Hansen
Background 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. Methods 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 computergenerated 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, NCT04354259. Findings 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 viral load above 10⁶ copies per mL, 15 (79%) of 19 patients in the peginterferon lambda group had undetectable virus on day 7, compared with six (38%) of 16 in the placebo group (OR 6•25 [95% CI 1•49-31•06]; p=0•012). Peginterferon lambda was well tolerated, and adverse events were similar between groups with mild and transient aminotransferase, concentration increases more frequently observed in the peginterferon lambda group. Two individuals met the threshold of grade 3 increase, one in each group, and no other grade 3 or 4 laboratory adverse events were reported. Interpretation Peginterferon lambda accelerated viral decline in outpatients with COVID-19, increasing the proportion of patients with viral clearance by day 7, particularly in those with high baseline viral load. Peginterferon lambda has potential to prevent clinical deterioration and shorten duration of viral shedding.
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