A Single-center, Pilot, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Ensifentrine in the Recovery of Hospitalized Patients With COVID-19
et al., NCT04527471, NCT04527471, May 2021
RCT 45 hospitalized COVID-19 patients showing no significant difference with ensifentrine 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, 150.0% higher, RR 2.50, p = 1.00, treatment 1 of 30 (3.3%), control 0 of 15 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm), day 60.
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risk of no recovery, 150.0% higher, RR 2.50, p = 1.00, treatment 1 of 30 (3.3%), control 0 of 15 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm), day 29.
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| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
MacDonald-Berko et al., 1 May 2021, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, 1 author, trial NCT04527471 (history).
Contact: margot.macdonald-berko@veronapharma.com.
Late treatment
is less effective
is less effective
