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
Late treatmentDouble-blind RCT · NCT04370236 · 79 patients · USA
Pegipanermin for COVID-19
Tesi et al. NCT04370236 · November 2021
Outcome
Improvement
Relative Risk · 95% CI
Higher mortality and ICU admission
Not statistically significant · p = 0.36 (mortality) and p = 0.15 (ICU admission)
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.
OutcomeImprovementEffect · pTreatmentControl
risk of death 289.7% higher · RR 3.90 · p = 0.36 289.7% higherRR 3.90p = 0.36 4 of 39 (10.3%) 1 of 38 (2.6%) treatment 4 of 39 (10.3%), control 1 of 38 (2.6%)
risk of ICU admission 241.0% higher · RR 3.41 · p = 0.15 241.0% higherRR 3.41p = 0.15 7 of 39 (17.9%) 2 of 38 (5.3%) treatment 7 of 39 (17.9%), control 2 of 38 (5.3%)
risk of progression 62.4% higher · RR 1.62 · p = 0.40 62.4% higherRR 1.62p = 0.40 10 of 39 (25.6%) 6 of 38 (15.8%) treatment 10 of 39 (25.6%), control 6 of 38 (15.8%)
hospitalization time 38.0% higher · relative time 1.38 · p = 0.16 38.0% higherrelative time 1.38p = 0.16 mean 9.8 (±10.17) n=39 mean 7.1 (±5.76) n=38 mean 9.8 (±10.17) n=39, mean 7.1 (±5.76) n=38

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).
$0 $500 $1,000+ Efficacy vs. cost for COVID-19 treatment protocols c19early.org November 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 November 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%
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