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Peer reviewedOpen accessCOVID-19SARS

Real-world effectiveness of early nirmatrelvir/ritonavir initiation after COVID-19 diagnosis in outpatient setting against severe illness, hospitalization, death, and long COVID in N3C

BMC Infectious Diseases·

Steve R. Makkar, Kristen Hansen, Arjun S. Yadaw, Therese Tripler, David Sahner, Josh Fessel, Nathan Hotaling, Hythem Sidky, Kenneth R. Gersing, Mariam Deacy, Rebecca Erwin-Cohen, Samuel Bozzette, Valery Gordon, Christopher Chute, Adam B. Wilcox, Adam M. Lee, Alexis Graves, Alfred Jerrod Anzalone, Amin Manna, Andrew T. Girvin, Benjamin Amor, Katie Rebecca Bradwell, Mark M. Bissell, Michael G. Kurilla, Shawn T. O’Neil, Amit Saha, Amy Olex, Andrea Zhou, Andrew E. Williams, Andrew M. Southerland, Anita Walden, Anjali Sharathkumar, Benjamin Bates, Brian Hendricks, Brijesh Patel, G. Caleb Alexander, Carolyn T. Bramante, Cavin Ward-Caviness, Charisse Madlock-Brown, Christine Suver, Christopher Dillon, Chunlei Wu, Clare Schmitt, Joni L. Rutter, Cliff Takemoto, Dan Housman, Davera Gabriel, Harold P. Lehmann, Richard L. Zhu, Stephanie S. Hong, Xiaohan Tanner Zhang, David A. Eichmann, Diego Mazzotti, Donald E. Brown, Eilis Boudreau, Elaine L. Hill, Emily Carlson Marti, Emily R. Pfaff, Kellie M. Walters, Evan French, Farrukh M. Koraishy, Randeep Jawa, Federico Mariona, Fred Prior, George Sokos, Greg Martin, Heidi Spratt, Hemalkumar B. Mehta, J. W. Awori Hayanga, Lee Pyles, Lesley Cottrell, Jami Pincavitch, Jaylyn Clark, Jeremy Richard Harper, Jessica Yasmine Islam, Jin Ge, Joel Gagnier, Johanna J. Loomba, John B. Buse, Jomol Mathew, Julie A. McMurry, Justin Guinney, Justin Starren, Karen Crowley, Ken Wilkins, Kenrick Cato, Kimberly Murray, Kristin Kostka, Lavance Northington, Lili M. Portilla, Marshall Clark, Mary Emmett, Matvey B. Palchuk, Melissa A. Haendel, Meredith Adams, Umit Topaloglu, Meredith Temple-O’Connor, Michele Morris, Nasia Safdar, Nicole Garbarini, Noha Sharafeldin, Ofer Sadan, Patricia A. Francis, Penny Wung Burgoon, Philip R. O. Payne, Rena C. Patel, Richard A. Moffitt, Rishikesan Kamaleswaran, Robert Hurley, Robert T. Miller, Saiju Pyarajan, Sam G. Michael, Sandeep K. Mallipattu, Satyanarayana Vedula, Scott Chapman, Soko Setoguchi, Steven G. Johnson, Tellen D. Bennett, Tiffany J. Callahan, Vignesh Subbian, Warren A. Kibbe, Wenndy Hernandez, Will Beasley, William Cooper, William Hillegass

DOI
10.1186/s12879-026-13588-w
PMID
PMCID
OpenAlex
W7203779271
Study type
Cohort study
Publisher
Springer Science and Business Media LLC
Article type
journal-article
Integrity
current

Why this research matters now

Findings suggest nirmatrelvir/ritonavir may reduce risks of both acute severe outcomes and post-acute sequelae including long-COVID in high-risk outpatient populations, supporting continued use as a therapeutic option.

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Structured evidence summary

Research question

The study evaluated real-world effectiveness of nirmatrelvir/ritonavir in preventing severe illness, hospitalization, death, and long-COVID among outpatients with COVID-19 who had at least one risk factor for severe disease.

Study design

Population-based retrospective cohort study using emulated target trials within the National COVID Cohort Collaborative, comparing nirmatrelvir/ritonavir initiators to non-initiators across sequential trials beginning on each of the first five days following COVID-19 diagnosis.

Population and setting

Nationwide cohort of outpatients with confirmed SARS-CoV-2 infection diagnosed between December 2021 and February 2023 in the United States, restricted to individuals with at least one risk factor for severe COVID-19 and without contraindicating conditions, medications, or immediate hospitalization at eligibility.

Main findings

Across 921,034 eligible person-trials, nirmatrelvir/ritonavir initiators demonstrated significantly lower hazards compared to non-initiators for all outcomes: severe illness (HR 0.76), hospitalization or death (HR 0.50), hospitalization alone (sdHR 0.52), death (HR 0.33), and long-COVID (sdHR 0.85). Larger associations were observed with earlier treatment initiation and among unvaccinated patients.

Public-health relevance

Findings suggest nirmatrelvir/ritonavir may reduce risks of both acute severe outcomes and post-acute sequelae including long-COVID in high-risk outpatient populations, supporting continued use as a therapeutic option.

Important limitations

This summary is limited to the supplied single-article abstract and metadata. The abstract does not explicitly state limitations; the original paper would be required for complete assessment of potential confounding, generalizability, and other methodological considerations relevant to decision-grade interpretation.

GIDS interpretation

This single retrospective cohort study provides real-world evidence regarding nirmatrelvir/ritonavir effectiveness in a large U.S. outpatient population. The emulated target trial design and sensitivity analyses strengthen causal inference, though residual confounding cannot be fully excluded. Findings are contextual to the study period and population characteristics and should not be extrapolated beyond the available evidence.

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Related GIDS surveillance

Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.

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Evidence relationships

This article has 7 auditable classifier relationships to diseases, places, topics, and study design.

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