Olgotrelvir as a Single-Agent Treatment of Nonhospitalized Patients with Covid-19
et al., NEJM Evidence, doi:10.1056/EVIDoa2400026, MPR-COV-301CN, NCT05716425, May 2024
RCT 1,212 outpatients with mild to moderate COVID-19 showing faster recovery with olgotrelvir.
Standard of Care (SOC) for COVID-19 in the study country,
China, is average with moderate efficacy for approved treatments1.
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risk of oxygen therapy, 66.6% lower, RR 0.33, p = 1.00, treatment 0 of 604 (0.0%), control 1 of 608 (0.2%), NNT 608, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
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risk of hospitalization, 66.6% lower, RR 0.33, p = 1.00, treatment 0 of 604 (0.0%), control 1 of 608 (0.2%), NNT 608, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
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risk of no recovery, 22.5% lower, HR 0.78, p < 0.001, treatment 604, control 608, inverted to make HR<1 favor treatment.
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| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
Jiang et al., 28 May 2024, Double Blind Randomized Controlled Trial, placebo-controlled, China, peer-reviewed, median age 33.0, 44 authors, study period February 2023 - June 2023, average treatment delay 2.0 days, trial NCT05716425 (history) (MPR-COV-301CN).
Contact: xxu@aceatherapeutics.com, 13911900791@163.com, luhongzhou@szsy.sustech.edu.cn.
Olgotrelvir as a Single-Agent Treatment of Nonhospitalized Patients with Covid-19
NEJM Evidence, doi:10.1056/evidoa2400026
BACKGROUND Olgotrelvir is an oral antiviral with dual mechanisms of action targeting severe acute respiratory syndrome coronavirus 2 main protease (i.e., M pro ) and human cathepsin L. It has potential to serve as a single-agent treatment of coronavirus disease 2019 (Covid-19). METHODS We conducted a phase 3, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of olgotrelvir in 1212 nonhospitalized adult participants with mild to moderate Covid-19, irrespective of risk factors, who were randomly assigned to receive orally either 600 mg of olgotrelvir or placebo twice daily for 5 days. The primary and key secondary end points were time to sustained recovery of a panel of 11 Covid-19-related symptoms and the viral ribonucleic acid (RNA) load. The safety end point was incidence of treatment-emergent adverse events.
RESULTS The baseline characteristics of 1212 participants were similar in the two groups. In the modified intention-to-treat population (567 patients in the placebo group and 558 in the olgotrelvir group), the median time to symptom recovery was 205 hours in the olgotrelvir group versus 264 hours in the placebo group (hazard ratio, 1.29; 95% confidence interval [CI], 1.13 to 1.46; P<0.001). The least squares mean (95% CI) changes of viral RNA load from baseline were -2.20 (-2.59 to -1.81) log 10 copies/ml in olgotrelvirtreated participants and -1.40 (-1.79 to -1.01) in participants receiving placebo at day 4. Skin rash (3.3%) and nausea (1.5%) were more frequent in the olgotrelvir group than in the placebo group; there were no treatment-related serious adverse events, and no deaths were reported.
Author Affiliations
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