Peginterferon Lambda-1a for treatment of outpatients with uncomplicated COVID-19: a randomized placebo-controlled trial
Prasanna Jagannathan, Jason R Andrews, Hector Bonilla, Haley Hedlin, Karen B Jacobson, Vidhya Balasubramanian, Natasha Purington, Savita Kamble, Christiaan R De Vries, Orlando Quintero, Kent Feng, Catherine Ley, Dean Winslow, Jennifer Newberry, Karlie Edwards, Colin Hislop, Ingrid Choong, Yvonne Maldonado, Jeffrey Glenn, Ami Bhatt, Catherine Blish, Taia Wang, Chaitan Khosla, Benjamin A Pinsky, Manisha Desai, Julie Parsonnet, Upinder Singh
Nature Communications, doi:10.1038/s41467-021-22177-1
Type III interferons have been touted as promising therapeutics in outpatients with coronavirus disease 2019 (COVID-19). We conducted a randomized, single-blind, placebocontrolled trial (NCT04331899) in 120 outpatients with mild to moderate COVID-19 to determine whether a single, 180 mcg subcutaneous dose of Peginterferon Lambda-1a (Lambda) within 72 hours of diagnosis could shorten the duration of viral shedding (primary endpoint) or symptoms (secondary endpoint). In both the 60 patients receiving Lambda and 60 receiving placebo, the median time to cessation of viral shedding was 7 days (hazard ratio [HR] = 0.81; 95% confidence interval [CI] 0.56 to 1.19). Symptoms resolved in 8 and 9 days in Lambda and placebo, respectively, and symptom duration did not differ significantly between groups (HR 0.94; 95% CI 0.64 to 1.39). Both Lambda and placebo were welltolerated, though liver transaminase elevations were more common in the Lambda vs. placebo arm (15/60 vs 5/60; p = 0.027). In this study, a single dose of subcutaneous Peginterferon Lambda-1a neither shortened the duration of SARS-CoV-2 viral shedding nor improved symptoms in outpatients with uncomplicated COVID-19.
Author contributions P.J., J.R.A., J.P., and U.S. designed the study and wrote the study protocol. C.L., H.H., J.P., V.B. developed study data instruments. C.H., I.C. provided study drug. P.J., J.R.A., H.B., K.B.J., S.K., C.R.d.V., O.Q., K.F., D.W., J.N., K.E., C.B., T.W., B.A.P., J.P., and U.S. collected data. C.H., I.C., Y.M., J.G., A.B., C.K. provided input on study procedures and data analysis. H.H., N.P., V.B., and M.D. prepared the statistical analysis plan and analyzed the data. All authors participated in data interpretation. K.B.J. and P.J. wrote the first draft and writing the manuscript and agreed on the decision to publish. There were no confidentiality agreements between the sponsors and authors.
Competing interests C.H. and I.C. are scientists at Eiger BioPharmaceuticals, Inc., which provided the Interferon Lambda used for this study. J.G. serves on the board of Eiger BioPharmaceuticals, Inc. C.H. and I.C. own stock and options of Eiger BioPharmaceuticals, Inc. J.G. has an equity interest in Eiger BioPharmaceuticals, Inc. J.G. and I.C. are inventors on a pending patent application relating to the use of interferon lambda for coronavirus. Eiger BioPharmaceuticals played no role in study design, conduct of the study, or analysis of the data. All other authors declare no competing interests.
Additional information
Supplementary information The online version contains supplementary material available at https://doi.org/10.1038/s41467-021-22177-1...
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