Evidence map›Paper›PMID 39321181›Full record

ArticlePloS one2024

A SONAR report on Nirmatrelvir/ritonavir-associated rebound COVID-19: Using new databases for evaluating new diseases.

Charles L Bennett, Joseph Magagnoli, Krishna Gundabolu, Peter Georgantopoulos, Akida Lebby, Gretchen Watson, Kevin Knopf, Linda Martin, Kenneth R Carson, William J Hrushesky and 5 more

Abstract read
In one paragraph

Article in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

15 authors.

Charles L BennettDepartment of Southern Network on Adverse Reactions (SONAR), University of South Carolina, Columbia, South Carolina, United States of America.ORCID 0000-0002-8645-5705
Joseph MagagnoliClinical Pharmacy and Outcomes Sciences, College of Pharmacy, University of South Carolina, Columbia, South Carolina, United States of America.
Krishna GundaboluDivision of Hematology/Oncology, Department of Internal Medicine, Omaha School of Medicine University of Nebraska, Omaha, Nebraska, United States of America.
Peter GeorgantopoulosDepartment of Southern Network on Adverse Reactions (SONAR), University of South Carolina, Columbia, South Carolina, United States of America.ORCID 0000-0002-4113-6655
Akida LebbyDepartment of Southern Network on Adverse Reactions (SONAR), University of South Carolina, Columbia, South Carolina, United States of America.
Gretchen WatsonDepartment of Southern Network on Adverse Reactions (SONAR), University of South Carolina, Columbia, South Carolina, United States of America.
Kevin KnopfDepartment of Southern Network on Adverse Reactions (SONAR), University of South Carolina, Columbia, South Carolina, United States of America.
Linda MartinDepartment of Southern Network on Adverse Reactions (SONAR), University of South Carolina, Columbia, South Carolina, United States of America.
Kenneth R CarsonDepartment of Southern Network on Adverse Reactions (SONAR), University of South Carolina, Columbia, South Carolina, United States of America.
William J HrusheskyDepartment of Southern Network on Adverse Reactions (SONAR), University of South Carolina, Columbia, South Carolina, United States of America.
Chadi NabhanDepartment of Southern Network on Adverse Reactions (SONAR), University of South Carolina, Columbia, South Carolina, United States of America.
Edward ZyszkowskiDepartment of Southern Network on Adverse Reactions (SONAR), University of South Carolina, Columbia, South Carolina, United States of America.
Edward B SmithDepartment of Southern Network on Adverse Reactions (SONAR), University of South Carolina, Columbia, South Carolina, United States of America.
Robert Peter GaleCentre for Haematology Research, Department of Immunology and Inflammation, Imperial College London, London, United Kingdom.
Steven T RosenCity of Hope Comprehensive Cancer Center and the Beckman Research Institute, Duarte, California, United States of America.

Funding

Research for Adverse Drug-Events And Reports (RADAR)R01CA102713 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI WEST, DENNIS PAUL · 2003 to 2010
$3.2M
NCI NIH HHS R01 CA102713
6 · The paper itself

Abstract

introductionIn May 2022, the Centers for Disease Control and Prevention disseminated an alert advising that "a few" persons with Nirmatrelvir/ritonavir (NM/R)-associated rebound of COVID-19 infection had been identified. Three case reports appearing as pre-print postings described the first cases. Analyses in March 2023 by NM/R's manufacturer and the Food and Drug Administration (FDA) reported no association between NM/R and COVID-19 rebound in a large phase 3 randomized clinical trial. Our study evaluated if social media databases or electronically disseminated new articles might provide insights related to the putative new toxicity, NM/R-associated COVID-19 rebound.

methodsInformation on NM/R-associated COVID-19 rebound cases was abstracted from preprint postings of non-peer-reviewed manuscripts, social media websites, electronically disseminated print and television media reports, a new FDA adverse event database for drugs that received Emergency Use Approval, and news articles in scientific journals.

resultsThirty-five persons experienced presumed or documented NM/R-associated COVID-19 rebound, based on information described in preprint services (n = 27), Twitter postings and related news articles (n = 7), and news articles without related Twitter reports (n = 1). These reports included information on dates of initial COVID-19 illness and rebound onset, COVID-19 testing, vaccine status, presentation, and outcome. A new FDA safety database identified 12,500 possible cases of this toxicity, but the quality of these data was poor. Preprint postings preceded peer-reviewed publications describing the same cases by four months. Social media websites including Instagram, Reddit, YouTube, the Center for Disease Control and Prevention's (CDC) Health Alert Network, CDC Twitter, and Facebook did not provide clinically meaningful information on individual cases.

conclusionPreprint services and Twitter facilitated identification of the largest case series of NM/R-associated COVID-19 rebound. The cases were reported in non-peer-reviewed media several weeks prior to the first peer-reviewed electronically disseminated publication of one person with this diagnosis.

Indexed as

COVID-19COVID-19 Drug TreatmentRitonavirSocial MediaAntiviral AgentsDatabases, FactualHumansIndazolesSARS-CoV-2United StatesUnited States Food and Drug AdministrationAntiviral AgentsIndazolesRitonavir

Identifiers

PMID39321181
PMCPMC11423969

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.