A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of ATYR1923 In Adult Patients With Severe Pneumonia Related to SARS-CoV-2 Infection (COVID-19)
et al., NCT04412668, NCT04412668, Oct 2020
RCT 32 hospitalized COVID-19 patients showing no significant differences with efzofitimod.
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.
|
risk of death, 290.9% higher, RR 3.91, p = 1.00, treatment 2 of 22 (9.1%), control 0 of 10 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).
|
|
hospitalization time, 24.4% higher, relative time 1.24, p = 0.53, treatment 12, control 10, both arms.
|
|
hospitalization time, 22.2% higher, relative time 1.22, p = 0.58, treatment mean 5.5 (±3.53) n=12, control mean 4.5 (±4.84) n=10.
|
|
hospitalization time, 55.6% higher, relative time 1.56, p = 0.74, treatment mean 7.0 (±22.6) n=10, control mean 4.5 (±4.84) n=10.
|
|
risk of no recovery, 11.1% higher, RR 1.11, p = 1.00, treatment 2 of 18 (11.1%), control 1 of 10 (10.0%), both arms, day 28.
|
|
risk of no recovery, 16.7% lower, RR 0.83, p = 1.00, treatment 1 of 12 (8.3%), control 1 of 10 (10.0%), NNT 60, 3 mg/kg, day 28.
|
|
risk of no recovery, 66.7% higher, RR 1.67, p = 1.00, treatment 1 of 6 (16.7%), control 1 of 10 (10.0%), 1 mg/kg, day 28.
|
|
risk of no recovery, 6.7% higher, RR 1.07, p = 1.00, treatment 2 of 15 (13.3%), control 1 of 8 (12.5%), both arms, day 14.
|
|
risk of no recovery, 20.0% lower, RR 0.80, p = 1.00, treatment 1 of 10 (10.0%), control 1 of 8 (12.5%), NNT 40, 3 mg/kg, day 14.
|
|
risk of no recovery, 60.0% higher, RR 1.60, p = 1.00, treatment 1 of 5 (20.0%), control 1 of 8 (12.5%), 1 mg/kg, day 14.
|
| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
Walker et al., 23 Oct 2020, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, 1 author, trial NCT04412668 (history).
Contact: clinicaltrials@atyrpharma.com.