Evidence map›Paper›PMID 40592258›Full record

Trial reportEBioMedicine2025

Integrated virologic analysis of resistance to nirmatrelvir/ritonavir in individuals across four phase 2/3 clinical studies for the treatment of COVID-19.

Mary Lynn Baniecki, Shunjie Guan, Devendra K Rai, Qingyi Yang, Jonathan T Lee, Li Hao, Edward Weinstein, Craig Hyde, Rhonda D Cardin, Holly Soares and 1 more

4 registry-linked trialsAbstract readClinical Trial, Phase IIClinical Trial, Phase III
In one paragraph

Trial report in EBioMedicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT04960202 phase2 / phase3completednot on this map

An interventional efficacy and safety, phase 2/3, double-blind, 2-arm study to investigate orally administered pf-07321332/ritonavir compared with placebo in nonhospitalized symptomatic adult participants with covid-19 who are at increased risk of progressing to severe illness

TypeinterventionalSponsorPfizerRan2021 to 2022Enrolled2,091ConditionsCOVID-19ArmsPF-07321332, Ritonavir, Placebo
NCT05011513 phase2 / phase3terminatednot on this map

An interventional efficacy and safety, phase 2/3, double-blind, 2 arm study to investigate orally administered pf 07321332/ritonavir compared with placebo in nonhospitalized symptomatic adult participants with covid-19 who are at low risk of progressing to severe illness

TypeinterventionalSponsorPfizerRan2021 to 2022Enrolled1,440ConditionsCOVID-19ArmsPF-07321332, Ritonavir, Placebo
NCT05438602 phase2completednot on this map

An interventional efficacy and safety, phase 2, randomized, double-blind, 3-arm study to investigate nirmatrelvir/ritonavir in nonhospitalized participants at least 12 years of age with symptomatic covid-19 who are immunocompromised

TypeinterventionalSponsorPfizerRan2022 to 2023Enrolled158ConditionsCOVID-19ArmsNirmatrelvir, Ritonavir, Placebo for nirmatrelvir, Placebo for ritonavir
NCT05567952 phase2completednot on this map

An interventional, efficacy and safety, phase 2, randomized, double-blind, 2-arm study to investigate a repeat 5-day course of nirmatrelvir/ritonavir compared to placebo/ritonavir in participants at least 12 years of age with rebound of covid-19 symptoms and rapid antigen test positivity

TypeinterventionalSponsorPfizerRan2022 to 2024Enrolled436ConditionsCOVID-19Armsnirmatrelvir, ritonavir, placebo for nirmatrelvir
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Mary Lynn BanieckiPfizer Research and Development, 1 Portland St, Cambridge, MA, 02139, USA. Electronic address: mary.baniecki@pfizer.com.
Shunjie GuanPfizer Research and Development, 1 Portland St, Cambridge, MA, 02139, USA. Electronic address: Shunjie.Guan@pfizer.com.
Devendra K RaiPfizer Research and Development, 280 Shennecossett Rd, Groton, CT, 06340, USA.
Qingyi YangPfizer Research and Development, 1 Portland St, Cambridge, MA, 02139, USA.
Jonathan T LeePfizer Research and Development, 401 N Middletown Rd, Pearl River, NY, 10965, USA.
Li HaoPfizer Research and Development, 401 N Middletown Rd, Pearl River, NY, 10965, USA.
Edward WeinsteinPfizer Research and Development, 66 Hudson Blvd, New York, NY, 10001, USA.
Craig HydePfizer Research and Development, 280 Shennecossett Rd, Groton, CT, 06340, USA.
Rhonda D CardinPfizer Research and Development, 401 N Middletown Rd, Pearl River, NY, 10965, USA.
Holly SoaresPfizer Research and Development, 280 Shennecossett Rd, Groton, CT, 06340, USA.
Jennifer HammondPfizer Research, Development & Medical, 500 Arcola Rd, Collegeville, 19426, PA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSARS-CoV-2 resistance to nirmatrelvir/ritonavir (NMV/r) surveillance is essential to identify emergence and track treatment-resistance.

methodsThis integrative virologic analysis across EPIC (Evaluation of Protease Inhibition of COVID-19) phase 2/3 clinical studies (-High Risk [HR], -Standard Risk [SR], -Immunocompromised [IC], -Retreatment) used next-generation sequencing to identify SARS-CoV-2 variants and M

findingsSequences were evaluated in 1605 NMV/r, 1216 placebo (PBO), and 114 PBO/r-treated participants. NMV/r M

interpretationIn EPIC, NMV-resistance mutations were infrequent. E166V was the only resistance-associated substitution but was not identified in participants experiencing hospitalisation or with immunocompromising conditions. NCT04960202, NCT05011513, NCT05438602, NCT05567952.

fundingPfizer Inc.

Indexed as

Antiviral AgentsCOVID-19 Drug TreatmentDrug Resistance, ViralOxadiazolesRitonavirSARS-CoV-2COVID-19FemaleHumansMaleMiddle AgedAntiviral AgentsOxadiazolesRitonavirCOVID-19EPIC trialsMutationsNirmatrelvirResistance

Identifiers

PMID40592258
PMCPMC12266373

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.