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An International, Multicenter, Randomized, Double-blind, Adaptive Placebo-controlled Study of the Efficacy and Safety of a Single Administration of Olokizumab and RPH-104 With Standard Therapy in Patients With Severe SARS-CoV-2 Infection (COVID-19)

Samsonov et al., NCT04380519, NCT04380519, Jan 2022
Late treatmentDouble-blind RCT · NCT04380519 · 372 patients · Russia
Olokizumab for COVID-19
Samsonov et al. NCT04380519 · January 2022
Outcome
Improvement
Relative Risk · 95% CI
Mortality
-50%1.50 · 0.55–4.09
Improvement 2+ points
30%0.70 · 0.42–1.15
Improvement 1+ points
30%0.70 · 0.45–1.09
00.511.52+
← Olokizumab
reduces riskOlokizumab
increases risk →
Higher mortality and greater improvement
Not statistically significant · p = 0.6 (mortality) and p = 0.21 (improvement)
RCT 248 hospitalized patients showing no significant differences with olokuzimab.
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Study covers olokizumab and goflikicept.
OutcomeImprovementEffect · pTreatmentControl
risk of death 50.0% higher · RR 1.50 · p = 0.60 50.0% higherRR 1.50p = 0.60 9 of 124 (7.3%) 6 of 124 (4.8%) treatment 9 of 124 (7.3%), control 6 of 124 (4.8%)day 29
risk of no improvement 2+ points 30.0% lower · RR 0.70 · p = 0.21 30.0% lowerRR 0.70p = 0.21 21 of 124 (16.9%) 30 of 124 (24.2%) treatment 21 of 124 (16.9%), control 30 of 124 (24.2%)NNT 14day 29
risk of no improvement 1+ points 29.7% lower · RR 0.70 · p = 0.14 29.7% lowerRR 0.70p = 0.14 26 of 124 (21.0%) 37 of 124 (29.8%) treatment 26 of 124 (21.0%), control 37 of 124 (29.8%)NNT 11day 29

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

Samsonov et al., 24 Jan 2022, Double Blind Randomized Controlled Trial, placebo-controlled, Russia, preprint, 1 author, trial NCT04380519 (history). Contact: sa.grishin@rpharm.ru.
$0 $500 $1,000+ Efficacy vs. cost for COVID-19 treatment protocols c19early.org November 2026 Russia Angola Colombia Kenya Mozambique Myanmar South Africa Peru Philippines USA Brazil France Italy Canada Pakistan Spain Vietnam Japan 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 Dominican Republic Bolivia Bulgaria Greece Slovakia Iceland New Zealand Trinidad and Tobago Mongolia Czechia Belarus Israel Haiti North Macedonia Hong Kong Qatar Panama Serbia Russia favored low-cost treatments.The average efficacy of treatments was moderate.Low-cost treatments improve early treatment, andprovide 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 November 2026 Russia Angola Colombia Kenya Mozambique Myanmar South Africa Peru Philippines USA Brazil France Italy Canada Pakistan Spain Vietnam Japan 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 Dominican Rep. Bolivia Côte d'Ivoire Bulgaria Greece Slovakia New Zealand Trinidad and Tobago Mongolia Zimbabwe Czechia Belarus Israel North Macedonia Hong Kong Qatar Panama Serbia Russia favored low-cost treatments.The average efficacy was moderate.Low-cost protocols improve early treatment,and add complementary/synergistic benefits. More effective More expensive 75% 50% 25% ≤0%
Late treatment
is less effective