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0 0.5 1 1.5 2+ Mortality 27% Improvement Relative Risk Mortality, day 28 61% Hospitalization 42% Hospitalization or ER >6h.. 51% primary c19early.org/il Reis et al. NCT04727424 TOGETHER Peg.. Lambda RCT EARLY Is early treatment with peginterferon lambda beneficial for COVID-19? Double-blind RCT 1,949 patients in Brazil (June 2021 - February 2022) Lower hospitalization (p=0.039) and fewer hosp./ER visits (p=0.0027) Multiple critical issues, see discussion Reis et al., New England J. Medicine, doi:10.1056/NEJMoa2209760 Favors peg.. lambda Favors control
Early Treatment with Pegylated Interferon Lambda for Covid-19
Reis et al., New England Journal of Medicine, doi:10.1056/NEJMoa2209760, TOGETHER, NCT04727424 (history)
Reis et al., Early Treatment with Pegylated Interferon Lambda for Covid-19, New England Journal of Medicine, doi:10.1056/NEJMoa2209760, TOGETHER, NCT04727424
Feb 2023   Source   PDF   DATA  
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Critical issues, see discussion. Authors claim data is on Vivli, but no data is listed for any arm of this trial
High-risk outpatient RCT with 931 peginterferon lambda patients and 1,018 control patients, showing significantly lower hospitalization/ER visits with treatment. Single subcutaneous injection.
There were 85/931 and 286/1018 patients for which baseline SARS-CoV-2 status was unknown, p = 1.4e-27 (about 1 in 704 septillion).
The most frequent risk factors were more common in the placebo group, for example obesity 39.1% control vs. 34.5% treatment, p = 0.04.
Authors claim patients were unaware or the randomization assignments, however some patients received oral placebo in a trial of a treatment requiring subcutaneous injection.
The numbers in Table 1 and Table S1 do not match, e.g., the text and Table 1 indicate 931 ITT interferon patients, while Table S1 shows 916.
All deaths in the placebo arm were attributed to COVID-19, while only 50% were in the interferon arm. One placebo death is listed as both due to COVID-19 and due to acute myeloid leukemia (Table S6).
Other arms of this trial show many critical issues [Reis], many of which may also apply to this arm.
See also [Kelleni].
risk of death, 27.1% lower, RR 0.73, p = 0.76, treatment 4 of 931 (0.4%), control 6 of 1,018 (0.6%), NNT 626, all-cause, Table S6.
risk of death, 61.0% lower, RR 0.39, p = 0.32, treatment 1 of 931 (0.1%), control 4 of 1,018 (0.4%), adjusted per study, attributed to COVID, day 28.
risk of hospitalization, 42.0% lower, RR 0.58, p = 0.04, treatment 21 of 931 (2.3%), control 40 of 1,018 (3.9%), NNT 60, adjusted per study, day 28.
hospitalization or ER >6hrs, 51.0% lower, RR 0.49, p = 0.003, treatment 25 of 931 (2.7%), control 57 of 1,018 (5.6%), NNT 34, adjusted per study, day 28, primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Reis et al., 9 Feb 2023, Double Blind Randomized Controlled Trial, placebo-controlled, Brazil, peer-reviewed, 41 authors, study period 24 June, 2021 - 7 February, 2022, trial NCT04727424 (history) (TOGETHER).
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