A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of INB03 in the Treatment of Participants With Pulmonary Complications From Coronavirus Disease (COVID-19)

Tesi et al., NCT04370236, NCT04370236, Nov 2021

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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%).

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%).

risk of progression, 62.4% higher, RR 1.62, p = 0.40, treatment 10 of 39 (25.6%), control 6 of 38 (15.8%).

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.

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

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

Tesi et al., 18 Nov 2021, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, 1 author, trial NCT04370236 (history).

This Paper Pegipanermin All

Late treatment
is less effective

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