1. In this randomized control trial, pegylated interferon lambda reduced the risk of coronavirus disease 2019 (COVID-19)-related hospitalization as compared to placebo control.
2. Pegylated interferon lambda treatment for COVID-19 was associated with a greater viral load reduction by day seven compared to placebo.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Type III interferons are naturally produced in response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and act as an early line of defense for upper respiratory tract infections. Previous clinical trials have demonstrated favorable safety and efficacy profile of pegylated interferon lambda for the treatment of viral infections, including hepatitis B, C, and D, as well as COVID-19. This large-scale, phase three randomized control trial assessed the efficacy of pegylated interferon lambda for the early treatment of COVID-19. Patients over the age of 18 with a COVID-19 diagnosis within seven days of randomization that fit the high-risk criterion for progression were randomized to receive either a single subcutaneous dose of pegylated interferon lambda treatment or a dose of placebo saline solution. For the primary outcome, significantly fewer patients in the interferon group had COVID-19-related hospitalizations or emergency room visits. For the secondary outcomes, the risk of death from COVID-19 and time to hospitalization were significantly lower in the interferon group. There was no significant difference in median time to recovery or the number of adverse events between the two groups. Patients in the interferon group had a greater reduction in viral load by day seven compared to the placebo group. As a limitation, results from this analysis are a subset of a larger multigroup trial, and the placebo group included both oral and subcutaneous administrations.
In-Depth [randomized controlled trial]: In this randomized controlled trial, single dose subcutaneous pegylated interferon lambda was compared to oral and subcutaneous saline placebo for the early treatment of COVID-19. Patients over the age of 18 with a COVID-19 diagnosis within seven days of baseline that fit the high-risk criterion for COVID-19 progression were randomized to receive either a single subcutaneous dose of pegylated interferon lambda (n=933) or a placebo control (n=1,018). Patients were followed for a total of 28 days. The primary outcome event, defined by COVID-19-related hospitalization or emergency department visit, occurred in fewer patients in the interferon group compared to the placebo group (2.7% and 5.6%, respectively; relative risk, 0.49; 95% Bayesian credible interval, 0.30 to 0.76). Subgroup analyses by age, sex, days since symptom onset, or vaccination status did not alter primary outcome results. Primary outcome events consisted mainly of COVID-19-related hospitalizations (74%) and occurred a median of five days after randomization. For the secondary outcomes, the risk of COVID-19-related hospitalization or death from any cause was lower in the interferon group (hazard ratio, 0.53; 95% Bayesian credible interval, 0.31 to 0.91). The median time to recovery and number of adverse events were not significantly different between groups. Viral load in the interferon group had a greater reduction by day seven than that in the placebo group (median log(10) decline, 8.29 and 5.16 in the interferon and placebo groups, respectively). This difference between groups in viral load reduction was driven by patients with higher viral load at baseline. In summary, this study demonstrates that early treatment with a single dose of subcutaneous pegylated interferon lambda reduces adverse outcomes of COVID-19 infections.
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