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

MacDonald-Berko et al., NCT04527471, NCT04527471, May 2021

Source

PDF

All
Studies

Meta
Analysis

https://c19early.org/macdonaldberko.html

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.

Important missing comments or errors? Let us know.

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.

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.

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

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

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.

This Paper Ensifentrine All

Late treatment
is less effective

Please send us corrections, updates, or comments. c19early involves the extraction of 200,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. IMA and WCH provide treatment protocols.

Submit

Post

@CovidAnalysis

FAQ

Public domain CC0 1.0