The CRISIS2 Study: A Phase 2, Randomized, Double Blind, Placebo-controlled, Multi-center Study Assessing the Safety and Anti-coronavirus Response of Suppression of Host Nucleotide Synthesis in Out-patient Adults With SARS-CoV-2

Powers et al., NCT04575038, CRISIS2, NCT04575038, Apr 2021

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https://c19early.org/powers2.html

RCT 115 outpatients in the USA, showing no significant differences with brequinar 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 hospitalization, 205.4% higher, RR 3.05, p = 0.49, treatment 1 of 56 (1.8%), control 0 of 59 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).

viral load, 33.9% higher, relative load 1.34, treatment 34, control 38, mid-recovery, day 8.

viral load, 7.9% lower, relative load 0.92, treatment 38, control 40, day 29.

viral load, 24.1% lower, relative load 0.76, treatment 36, control 39, day 15.

viral load, 13.9% higher, relative load 1.14, treatment 39, control 40, day 4.

time to viral-, 50.0% higher, relative time 1.50, treatment 43, control 45.

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

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

Powers et al., 28 Apr 2021, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, 1 author, trial NCT04575038 (history) (CRISIS2). Contact: clinical@clearcreekbio.com.

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