A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of INB03 in the Treatment of Participants With Pulmonary Complications From Coronavirus Disease (COVID-19)
et al., NCT04370236, NCT04370236, Nov 2021
RCT 79 hospitalized COVID-19 patients showing no significant differences with pegipanermin (INB03) 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.
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risk of death, 289.7% higher, RR 3.90, p = 0.36, treatment 4 of 39 (10.3%), control 1 of 38 (2.6%).
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risk of ICU admission, 241.0% higher, RR 3.41, p = 0.15, treatment 7 of 39 (17.9%), control 2 of 38 (5.3%).
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risk of progression, 62.4% higher, RR 1.62, p = 0.40, treatment 10 of 39 (25.6%), control 6 of 38 (15.8%).
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hospitalization time, 38.0% higher, relative time 1.38, p = 0.16, treatment mean 9.8 (±10.17) n=39, control mean 7.1 (±5.76) n=38.
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| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
Tesi et al., 18 Nov 2021, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, 1 author, trial NCT04370236 (history).
Pegipanermin (XPro1595, INB03) is a biologic immunomodulator that uses dominant-negative TNF technology to selectively inhibit soluble tumor necrosis factor (sTNF) while sparing transmembrane TNF and its receptors.
Late treatment
is less effective
is less effective
