Trial reportAntimicrobial agents and chemotherapy2022
A Randomized Phase 2/3 Study of Ensitrelvir, a Novel Oral SARS-CoV-2 3C-Like Protease Inhibitor, in Japanese Patients with Mild-to-Moderate COVID-19 or Asymptomatic SARS-CoV-2 Infection: Results of the Phase 2a Part.
Trial report in Antimicrobial agents and chemotherapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 80 papers, 4 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
80 citing papers in PubMed, 4 syntheses or guidelines pooled it, 129 citations in OpenAlex.
- Efficacy and safety of Ensitrelvir in COVID-19 patients: a systematic review and meta-analysis with focus on viral clearance and RNA change.European journal of clinical pharmacology · 2026Pooled it
- Pooled it
- 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
- A Phase 3 Study of Ensitrelvir in Japanese Participants Aged 6-11 Years with SARS-CoV-2 Infection.Journal of the Pediatric Infectious Diseases Society · 2026Trial
- A randomized, double-blind, placebo-controlled trial of niclosamide nanohybrid for the treatment of patients with mild to moderate COVID-19.Nature communications · 2025Trial
- Ensitrelvir for the Treatment of Nonhospitalized Adults with COVID-19: Results from the SCORPIO-HR, Phase 3, Randomized, Double-blind, Placebo-Controlled Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Trial
- Implementation of an Online Drug-Drug Interaction Screener for the STRIVE Ensitrelvir Trial for COVID-19.Open forum infectious diseases · 2025Trial
- Population Pharmacokinetics of Ensitrelvir in Healthy Participants and Participants with SARS-CoV-2 Infection in the SCORPIO-SR Study.Clinical pharmacokinetics · 2024Trial
- Efficacy and Safety of Ensitrelvir for Asymptomatic or Mild COVID-19: An Exploratory Analysis of a Multicenter, Randomized, Phase 2b/3 Clinical Trial.Influenza and other respiratory viruses · 2024Trial
- SARS-CoV-2 viral dynamics in a placebo-controlled phase 2 study of patients infected with the SARS-CoV-2 Omicron variant and treated with pomotrelvir.Microbiology spectrum · 2024Trial
- Efficacy and Safety of 5-Day Oral Ensitrelvir for Patients With Mild to Moderate COVID-19: The SCORPIO-SR Randomized Clinical Trial.JAMA network open · 2024Trial
- Oral Simnotrelvir for Adult Patients with Mild-to-Moderate Covid-19.The New England journal of medicine · 2024Trial
- A Phase 1 Study of Ensitrelvir Fumaric Acid Tablets Evaluating the Safety, Pharmacokinetics and Food Effect in Healthy Adult Populations.Clinical drug investigation · 2023Trial
- Efficacy and Safety of Ensitrelvir in Patients With Mild-to-Moderate Coronavirus Disease 2019: The Phase 2b Part of a Randomized, Placebo-Controlled, Phase 2/3 Study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Trial
- Article
- Association between clinical symptoms and time to pharyngeal PCR negativity among mild omicron COVID-19 patients: a retrospective study.BMC infectious diseases · 2026Article
- Targeting SARS-CoV-2 Non-Structural Proteins: A Blueprint for Next-Generation Small-Molecule Coronavirus Antivirals.Pharmaceutics · 2026Review
- Prospective Study of Treatment with Ensitrelvir for COVID-19 in Patients Undergoing Hemodialysis (PROTECT-HD).Infectious diseases and therapy · 2026Article
- Ordinary differential equation models of SARS-CoV-2 replication dynamics and antiviral drug efficacies.Npj viruses · 2026Review
20 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This multicenter, double-blind, phase 2a part of a phase 2/3 study assessed the efficacy and safety of ensitrelvir, a novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 3C-like protease inhibitor, in Japanese patients with mild-to-moderate coronavirus disease 2019 (COVID-19) or asymptomatic SARS-CoV-2 infection. Sixty-nine patients were randomized (1:1:1) to orally receive 5-day ensitrelvir fumaric acid (375 mg on day 1 followed by 125 mg daily, or 750 mg on day 1 followed by 250 mg daily) or placebo and followed up until day 28. The primary outcome was the change from baseline in the SARS-CoV-2 viral titer. A total of 16, 14, and 17 patients in the ensitrelvir 125 mg, ensitrelvir 250 mg, and placebo groups, respectively, were included in the intention-to-treat population (mean age: 38.0 to 40.4 years). On day 4, the change from baseline in SARS-CoV-2 viral titer (log
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.