A Randomized Phase 2 Study of Anti-IL-8 Therapy Versus Standard of Care in the Treatment of Hospitalized Patients With Severe COVID-19

Stein et al., NCT04347226, NCT04347226, May 2025

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https://c19early.org/stein.html

RCT 43 hospitalized patients in the USA showing no significant benefit with HuMax-IL8 (BMS-986253) treatment.

Standard of Care (SOC) for COVID-19 in the study country, the USA, is very poor with very low average efficacy for approved treatments1. Only expensive, high-profit treatments were approved. Low-cost treatments were excluded, reducing the probability of treatment—especially early—due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments. This may explain in part the very high mortality seen in this study. Results may differ in countries with improved SOC.

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risk of death, 6.2% higher, RR 1.06, p = 1.00, treatment 11 of 29 (37.9%), control 5 of 14 (35.7%).

risk of death, 3.4% lower, RR 0.97, p = 1.00, treatment 8 of 29 (27.6%), control 4 of 14 (28.6%), NNT 102, day 28.

risk of ICU admission, 100% higher, RR 2.00, p = 0.59, treatment 9 of 18 (50.0%), control 1 of 4 (25.0%).

time to improvement, 107.1% higher, relative time 2.07, p = 0.08, treatment mean 29.0 (±30.2) n=29, control mean 14.0 (±8.59) n=14.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

1. c19early.org, c19early.org/soc/usa.html.c19early.org/soc/usa.html.

Stein et al., 22 May 2025, Randomized Controlled Trial, USA, preprint, 1 author, trial NCT04347226 (history). Contact: mns2146@cumc.columbia.edu.

This Paper HuMax-IL8 All

Late treatment
is less effective

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