Evidence map›Paper›PMID 39523543›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2025

Alleviation of COVID-19 Symptoms and Reduction in Healthcare Utilization Among High-risk Patients Treated With Nirmatrelvir/Ritonavir (NMV/R): A Phase 3 Randomized Trial.

Jennifer Hammond, Heidi Leister-Tebbe, Annie Gardner, Paula Abreu, Weihang Bao, Wayne Wisemandle, Wajeeha Ansari, Magdalena Alicja Harrington, Abraham Simón-Campos, Kara W Chew and 2 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIClinical Trial, Phase II
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 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 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 citing papers in PubMed.

  1. Trial
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  7. Observational
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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

12 authors.

Jennifer HammondPfizer Research and Development, Pfizer, Collegeville, Pennsylvania, USA.
Heidi Leister-TebbePfizer Research and Development, Pfizer, Collegeville, Pennsylvania, USA.
Annie GardnerPfizer Research and Development, Pfizer, Cambridge, Massachusetts, USA.
Paula AbreuPfizer Research and Development, Pfizer, New York, New York, USA.
Weihang BaoPfizer Research and Development, Pfizer, New York, New York, USA.
Wayne WisemandlePfizer Research and Development, Pfizer, Lake Forest, Illinois, USA.
Wajeeha AnsariGlobal Access & Value, Pfizer, New York, New York, USA.ORCID 0000-0002-1910-5836
Magdalena Alicja HarringtonGlobal Access & Value, Pfizer, New York, New York, USA.
Abraham Simón-CamposKöhler and Milstein Research, Anahuac-Mayab University, Mérida, Yucatan, Mexico.
Kara W ChewInfectious Diseases, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California, USA.ORCID 0000-0003-4865-4348
Rienk PypstraPfizer Research and Development, Pfizer, New York, New York, USA.
James M RusnakPfizer Research and Development, Pfizer, Tampa, Florida, USA.

Funding

Pfizer Inc
6 · The paper itself

Abstract

backgroundNirmatrelvir/ritonavir (NMV/r) is an oral antiviral treatment for mild to moderate coronavirus disease 2019 (COVID-19).

methodsThis phase 2/3, double-blind, randomized (1:1) study assessed oral NMV/r 300 mg/100 mg versus placebo every 12 hours for 5 days in high-risk, unvaccinated, nonhospitalized, symptomatic adults with COVID-19 from 343 sites across 21 countries. In testing the primary endpoint of COVID-19‒related hospitalization and all-cause deaths and key secondary endpoints, including symptom duration and COVID-19‒related medical visits, type I error was controlled with prespecified sequential testing and the Hochberg procedure.

resultsAmong 2113 randomized patients enrolled from July 2021 through December 2021, 1966 (NMV/r, n = 977; placebo, n = 989) were included in the prespecified analysis population (symptom onset ≤5 days, did not receive monoclonal antibodies). NMV/r significantly reduced times to sustained alleviation (median, 13 vs 15 days; hazard ratio = 1.27, P < .0001) and resolution (16 vs 19 days; hazard ratio = 1.20, P = .0022) through day 28 and significantly reduced the number of COVID-19‒related medical visits and the proportion of patients with such visits. Hospitalized patients treated with NMV/r had shorter stays, none required intensive care unit admission or mechanical ventilation, and all were discharged to home/self-care. Fewer NMV/r-treated patients required additional treatment for COVID-19. No NMV/r-treated patients died through week 24 compared with 15 placebo-treated patients.

conclusionsIn addition to reducing COVID-19‒related hospitalization or death from any cause through day 28, NMV/r was found to also reduce duration of COVID-19 symptoms and utilization of healthcare resources versus placebo in patients at high risk of progressing to severe disease. CLINICAL TRIAL INFORMATION: ClinicalTrials.gov, NCT04960202, https://clinicaltrials.gov/study/NCT04960202.

Indexed as

Antiviral AgentsCOVID-19COVID-19 Drug TreatmentPatient Acceptance of Health CareRitonavirAdultAgedDouble-Blind MethodFemaleHospitalizationHumansMaleMiddle AgedSARS-CoV-2Treatment OutcomeAntiviral AgentsRitonavirCOVID-19 drug therapyEPIC-HRnirmatrelvirritonavirsymptoms

Identifiers

PMID39523543
PMCPMC11848284

What OpenQuestion holds

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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.