Early Treatment with Pegylated Interferon Lambda for Covid-19.
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Reis Gilmar, Moreira Silva Eduardo A S, Medeiros Silva Daniela C, Thabane Lehana, Campos Vitoria H S, Ferreira Thiago S, Santos Castilho V Q, Nogueira Ana M R, Almeida Ana P F G, Savassi Leonardo C M, Figueiredo-Neto Adhemar D, Dias Ana C F, Freire Júnior Adelino M, Bitarães Carina, Milagres Aline C, Callegari Eduardo D, Simplicio Maria I C, Ribeiro Luciene B, Oliveira Rosemary, Harari Ofir, Wilson Lindsay A, Forrest Jamie I, Ruton Hinda, Sprague Sheila, McKay Paula, Guo Christina M, Limbrick-Oldfield Eve H, Kanters Steve, Guyatt Gordon H, Rayner Craig R, Kandel Christopher, Biondi Mia J, Kozak Robert, Hansen Bettina, Zahoor M Atif, Arora Paul, Hislop Colin, Choong Ingrid, Feld Jordan J, Mills Edward J, Glenn Jeffrey S, TOGETHER Investigators
Аннотация
METHODS: We conducted a randomized, controlled, adaptive platform trial involving predominantly vaccinated adults with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in Brazil and Canada. Outpatients who presented with an acute clinical condition consistent with Covid-19 within 7 days after the onset of symptoms received either pegylated interferon lambda (single subcutaneous injection, 180 μg) or placebo (single injection or oral). The primary composite outcome was hospitalization (or transfer to a tertiary hospital) or an emergency department visit (observation for >6 hours) due to Covid-19 within 28 days after randomization.
RESULTS: A total of 933 patients were assigned to receive pegylated interferon lambda (2 were subsequently excluded owing to protocol deviations) and 1018 were assigned to receive placebo. Overall, 83% of the patients had been vaccinated, and during the trial, multiple SARS-CoV-2 variants had emerged. A total of 25 of 931 patients (2.7%) in the interferon group had a primary-outcome event, as compared with 57 of 1018 (5.6%) in the placebo group, a difference of 51% (relative risk, 0.49; 95% Bayesian credible interval, 0.30 to 0.76; posterior probability of superiority to placebo, >99.9%). Results were generally consistent in analyses of secondary outcomes, including time to hospitalization for Covid-19 (hazard ratio, 0.57; 95% Bayesian credible interval, 0.33 to 0.95) and Covid-19-related hospitalization or death (hazard ratio, 0.59; 95% Bayesian credible interval, 0.35 to 0.97). The effects were consistent across dominant variants and independent of vaccination status. Among patients with a high viral load at baseline, those who received pegylated interferon lambda had lower viral loads by day 7 than those who received placebo. The incidence of adverse events was similar in the two groups.
CONCLUSIONS: Among predominantly vaccinated outpatients with Covid-19, the incidence of hospitalization or an emergency department visit (observation for >6 hours) was significantly lower among those who received a single dose of pegylated interferon lambda than among those who received placebo. (Funded by FastGrants and others; TOGETHER ClinicalTrials.gov number, NCT04727424.).