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
Late treatmentRCT · NCT04347226 · 43 patients · USA
HuMax-IL8 for COVID-19
Stein et al. NCT04347226 · May 2025
Higher ICU admission and slower improvement
Not statistically significant · p = 0.59 (ICU admission) and p = 0.077 (slower improvement)
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 for early treatment. Low-cost treatments were excluded, reducing the probability of early treatment 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 29.0 [5.0-27.0] n=29, control 14.0 [4.0-13.0] n=14.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Stein et al., 22 May 2025, Randomized Controlled Trial, USA, preprint, 1 author, trial NCT04347226 (history). Contact: mns2146@cumc.columbia.edu.
$0 $500 $1,000+ Efficacy vs. cost for COVID-19 treatment protocols c19early.org October 2026 USA Angola Colombia Kenya Mozambique Myanmar South Africa Peru Philippines Vietnam Japan Argentina Nepal Iran Bangladesh Ethiopia Ghana Germany Mexico South Korea United Kingdom Saudi Arabia Algeria Morocco Yemen Poland Uzbekistan India China Venezuela DR Congo Madagascar Thailand Uganda Egypt Nigeria Taiwan Fiji Zambia Bosnia-Herzegovina Jordan Georgia Switzerland Dominican Republic Bolivia Côte d'Ivoire Eritrea Togo Bulgaria Greece Slovakia Iceland New Zealand Trinidad and Tobago Mongolia Czechia Belarus Israel Haiti North Macedonia Hong Kong Qatar Panama Serbia USA favored high-profit treatments.The average efficacy of treatments was very low.High-cost protocols reduce early treatment, andforgo complementary/synergistic benefits. More effective More expensive 75% 50% 25% ≤0%
$0 $500 $1,000+ Efficacy vs. cost for COVID-19treatment protocols worldwide c19early.org October 2026 USA Angola Colombia Kenya Mozambique Myanmar South Africa Peru Philippines Vietnam Japan Argentina Nepal Iran Bangladesh Ethiopia Ghana Germany Mexico South Korea United Kingdom Saudi Arabia Algeria Morocco Yemen Poland Uzbekistan India China Venezuela DR Congo Madagascar Thailand Uganda Egypt Taiwan Fiji Zambia Jordan Georgia Switzerland Dominican Rep. Bolivia Côte d'Ivoire Eritrea Togo Sri Lanka Bulgaria Greece Slovakia New Zealand Trinidad and Tobago Mongolia Czechia Belarus Israel North Macedonia Hong Kong Qatar Panama Serbia USA favored high-profit treatments.The average efficacy was very low.High-cost protocols reduce early treatment,and forgo complementary/synergistic benefits. More effective More expensive 75% 50% 25% ≤0%
Late treatment
is less effective
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