ArticleThe Lancet regional health. Western Pacific2023
Efficacy and safety of SIM0417 (SSD8432) plus ritonavir for COVID-19 treatment: a randomised, double-blind, placebo-controlled, phase 1b trial.
Article in The Lancet regional health. Western Pacific, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05369676 (Randomized, Double-blind, Phase Ib Clinical Trial to Evaluate the Safety, Pharmacodynamics, and Pharmacokinetic of SSD8432/ Ritonavir Multiple Doses in Treatment of Adults With Asymptomatic Infection, Mild, and Common Type of COVID-19), which is not on this map. Cited by 20 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Randomized, Double-blind, Phase Ib Clinical Trial to Evaluate the Safety, Pharmacodynamics, and Pharmacokinetic of SSD8432/ Ritonavir Multiple Doses in Treatment of Adults With Asymptomatic Infection, Mild, and Common Type of COVID-19
Who cites it
20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 33 citations in OpenAlex.
- Efficacy and safety of 3CL protease inhibitors in patients with mild or moderate COVID-19: a systematic review and meta-analysis of randomized controlled trials.Virology journal · 2025Pooled it
- Drug treatments for mild or moderate covid-19: systematic review and network meta-analysis.BMJ (Clinical research ed.) · 2025Pooled it
- Model-informed drug development in public health emergency of international concern: accelerating marketing authorization of simnotrelvir.Antimicrobial agents and chemotherapy · 2025Trial
- Efficacy and safety of SHEN26, a novel oral small molecular RdRp inhibitor for COVID-19 treatment: a multicenter, randomized, double-blinded, placebo-controlled, phase II clinical trial.Virology journal · 2025Trial
- Oral Simnotrelvir for Adult Patients with Mild-to-Moderate Covid-19.The New England journal of medicine · 2024Trial
- Current landscape of innovative drug development and regulatory support in China.Signal transduction and targeted therapy · 2025Review
- Shufeng Jiedu Granule against mild COVID-19: Protocol of the randomized, double-blind, placebo-controlled, multi-center heal-COVID phase III study.Chinese herbal medicines · 2025Article
- Effectiveness and Safety of Simnotrelvir/Ritonavir and Nirmatrelvir/Ritonavir in the Treatment of Moderate to Severe COVID-19.Immunity, inflammation and disease · 2025Article
- Article
- Optimization of SARS-CoV-2 MInternational journal of molecular sciences · 2025Article
- Adverse drug reactions associated with COVID-19 management.Naunyn-Schmiedeberg's archives of pharmacology · 2024Review
- Advances in the Search for SARS-CoV-2 MPathogens (Basel, Switzerland) · 2024Review
- Identification of novel small-molecule inhibitors of SARS-CoV-2 by chemical genetics.Acta pharmaceutica Sinica. B · 2024Article
- Review
- Inhibitors of SARS-CoV-2 Main Protease (Mpro) as Anti-Coronavirus Agents.Biomolecules · 2024Review
- Review
- On the origins of SARS-CoV-2 main protease inhibitors.RSC medicinal chemistry · 2024Review
- Epigenetic regulation of human FOXP3+ Tregs: from homeostasis maintenance to pathogen defense.Frontiers in immunology · 2024Review
- Small-molecule anti-COVID-19 drugs and a focus on China's homegrown mindeudesivir (VV116).Frontiers of medicine · 2023Review
- Deuremidevir and Simnotrelvir-Ritonavir for the Treatment of COVID-19.ACS pharmacology & translational science · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: SIM0417 (SSD8432) is an orally administered coronavirus main proteinase (3CL Methods: This was a randomised, double-blind, placebo-controlled, phase 1b study in China. Adults with asymptomatic infection, mild or moderate COVID-19 were randomly assigned (3:3:2) to receive either 750 mg SIM0417 plus 100 mg ritonavir, 300 mg SIM0417 plus 100 mg ritonavir or placebo every 12 h for 10 doses. The main efficacy endpoints included SARS-CoV-2 viral load, proportion of participants with positive SARS-CoV-2 nucleic acid test and time to alleviation of COVID-19 symptoms. This trial is registered with ClinicalTrials.gov, NCT05369676. Findings: Between May 12 and August 29, 2022, 32 participants were enrolled and randomised to high dose group (n = 12), low dose group (n = 12) or placebo (n = 8). The viral load change from baseline in high dose group was statistically lower compared with placebo, with a maximum mean difference of -2.16 ± 0.761 log Interpretation: SIM0417 plus ritonavir was generally well tolerated. The efficacy of SIM0417 showed a monotonic dose-response relationship, and the 750 mg SIM0417 plus 100 mg ritonavir was selected as the recommended clinical dose. Funding: The study was funded by Jiangsu Simcere Pharmaceutical Co., Ltd.
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