Evidence map›Paper›PMID 40809391›Full record

ArticleOpen forum infectious diseases2025

Patient-Reported Outcomes of Nirmatrelvir Treatment for High-Risk, Nonhospitalized Adults With Symptomatic COVID-19.

Wajeeha Ansari, Henriette Coetzer, Kelly A Gebo, Jinma Ren, Amie Scott, Joseph C Cappelleri, Ashley S Cha-Silva, Heidi Leister-Tebbe

Registry-linked trialAbstract read
In one paragraph

Article in Open forum infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04960202 (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), which is 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
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
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

8 authors.

Wajeeha AnsariGlobal Biopharmaceuticals Group, Pfizer Inc., New York, New York, USA.ORCID https://orcid.org/0000-0002-1910-5836
Henriette CoetzerBlue Health Intelligence® (BHI®), Chicago, Illinois, USA.
Kelly A GeboJohns Hopkins University School of Medicine, Baltimore, Maryland, USA.ORCID https://orcid.org/0000-0003-4010-398X
Jinma RenGlobal Biometrics and Data Management, Pfizer Inc., Collegeville, Pennsylvania, USA.
Amie ScottGlobal Real World Evidence, Pfizer Inc., New York, New York, USA.ORCID https://orcid.org/0000-0002-1488-2687
Joseph C CappelleriGlobal Biometrics and Data Management, Pfizer Inc., Groton, Connecticut, USA.
Ashley S Cha-SilvaGlobal Biopharmaceuticals Group, Pfizer Inc., New York, New York, USA.ORCID https://orcid.org/0000-0002-8484-6251
Heidi Leister-TebbePfizer Research and Development, Pfizer Inc., Collegeville, Pennsylvania, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Nirmatrelvir/ritonavir (NMV/r) is an antiviral treatment for COVID-19. We describe patient-reported outcomes with NMV/r in nonhospitalized adults with COVID-19 at high risk of severe disease. Methods: In a phase 2/3 double-blind study, high-risk adults with SARS-CoV-2 and ≤5 days of symptoms were randomized 1:1 to receive NMV/r or placebo twice daily for 5 days. Patients recorded responses to 3 Global Impression Questions (GIQs) daily through day 28 to assess return to usual health, return to usual activities, and overall severity of COVID-19-related symptoms. The COVID-19-specific Work Productivity and Activity Impairment Questionnaire (WPAI-COVID-19) and EuroQol Quality of Life 5-dimension 5-level scale (EQ-5D-5L) were completed at specified visits through week 24. Results: Compared with placebo, patients receiving NMV/r had a significant 3-day reduction in median time to return to usual health (hazard ratio [HR], 1.3; 95% confidence interval [CI], 1.2‒1.4; Conclusions: Patients receiving NMV/r for COVID-19 reported a reduced duration and severity of COVID-19 symptoms based on their global impression of overall symptom burden and quicker return to usual health and usual activities compared with those receiving placebo. Clinical Trial Information: ClinicalTrials.gov, NCT04960202, https://clinicaltrials.gov/study/NCT04960202.

Indexed as

antiviral agentsCOVID-19/drug therapyhealth-related quality of lifepatient outcomesviral protease inhibitors

Identifiers

PMID40809391
PMCPMC12345624

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.