Evidence map›Paper›PMID 36586513›Full record

ArticleClinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases2023

Time to negative PCR conversion amongst high-risk patients with mild-to-moderate Omicron BA.1 and BA.2 COVID-19 treated with sotrovimab or nirmatrelvir.

Guillaume Martin-Blondel, Anne-Geneviève Marcelin, Cathia Soulié, Sofia Kaisaridi, Clovis Lusivika-Nzinga, Karen Zafilaza, Céline Dorival, Laura Nailler, Anaïs Boston, Anne-Marie Ronchetti and 24 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter Study
In one paragraph

Article in Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04885452 (Prevention of COVID-19 Complications in High-risk Subjects Infected by SARS-CoV-2 and Eligible for Treatment Under a Cohort ATU), which is not on this map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
2.3field-weighted citation impact, top 10% of its field
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.

NCT04885452 completednot on this map

Prevention of COVID-19 Complications in High-risk Subjects Infected by SARS-CoV-2 and Eligible for Treatment Under a Cohort ATU ('Autorisation Temporaire d'Utilisation') or or Authorisation for Early Access (AAP). A Prospective Cohort.

TypeobservationalSponsorANRS, Emerging Infectious DiseasesRan2021 to 2023Enrolled756ConditionsSARS-CoV Infection, Covid19Armsbiobank
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 23 citations in OpenAlex.

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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

34 authors at 20 institutions in 3 countries.

Guillaume Martin-BlondelService des Maladies Infectieuses et Tropicales, CHU de Toulouse, France; Institut Toulousain des Maladies Infectieuses et Inflammatoires (Infinity) INSERM, Université Toulouse III., Toulouse, France. Electronic address: martin-blondel.g@chu-toulouse.fr.
Anne-Geneviève MarcelinSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpitaux Universitaires Pitié-Salpêtrière - Charles Foix, Laboratoire de Virologie, Paris, France.
Cathia SouliéSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpitaux Universitaires Pitié-Salpêtrière - Charles Foix, Laboratoire de Virologie, Paris, France.
Sofia KaisaridiSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique (IPLESP), Paris, France.
Clovis Lusivika-NzingaSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique (IPLESP), Paris, France.
Karen ZafilazaSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpitaux Universitaires Pitié-Salpêtrière - Charles Foix, Laboratoire de Virologie, Paris, France.
Céline DorivalSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique (IPLESP), Paris, France.
Laura NaillerANRS MIE (France Recherche Nord & Sud Sida-HIV Hépatites, Maladies Infectieuses Emergentes), Paris, France.
Anaïs BostonANRS MIE (France Recherche Nord & Sud Sida-HIV Hépatites, Maladies Infectieuses Emergentes), Paris, France.
Anne-Marie RonchettiDepartment of Clinical Hematology, Centre Hospitalier Sud-Francilien, Corbeil-Essonnes, France.
Cléa MelenotteService de Maladies Infectieuses, Hôpital Necker Enfants malades, APHP, Paris, France.
André CabiéUniversité des Antilles INSERM PCCEI UMR 1058 Université de Montpellier EFS, CHU de Martinique and INSERM, Fort-de-France, Martinique, France.
Christophe ChoquetEmergency Department, Bichat-Claude Bernard Hospital, Paris, France.
Albert Trinh-DucEmergency Department, Hospital Centre of Agen, Agen, France.
Karine LacombeInfectious Diseases Department, St Antoine Hospital, Sorbonne Université, INSERM IPLESP, Paris, France.
Géraldine GaubeService des Maladies Infectieuses et Tropicales, CHU de Toulouse, France.
François CoustillèresService de Médecine Interne - Maladies Infectieuses, CHRU Tours, Tours, France.
Valérie PourcherService des Maladies Infectieuses et Tropicales, Hôpital de la Pitié Salpêtrière, Assistance Publique Hôpitaux de Paris, Université de Paris Sorbonne, Paris, France.
Jean-Philippe MartellosioService de Médecine Interne, Maladies Infectieuses et Tropicales, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.
Nathan Peiffer-SmadjaInfectious Disease Department, Bichat-Claude Bernard Hospital, Assistance Publique Hôpitaux de Paris, Paris, France.
Marie ChauveauDepartment of Infectious Diseases, Hotel-Dieu Hospital, Nantes, France; INSERM, Nantes University Hospital, Nantes, France.
Pierre HoussetDepartment of Nephrology, Centre Hospitalier Sud-Francilien, Corbeil-Essonnes, France.
Lionel PirothINSERM, Clinical Epidemiology/Clinical Trials Unit, Clinical Investigation Centre, Dijon University Hospital, Dijon, France; Infectious Diseases Department, Dijon University Hospital, Dijon, France; Faculty of Medicine, University of Bourgogne-Franche-Comté, Dijon, France.
Mathilde DevauxCHI Poissy-Saint-Germain-en-Laye, Saint-Germain-en-Laye, France.
Gilles PialouxDépartement de Maladies Infectieuses, Hôpital Tenon, Assistance Publique Hôpitaux de Paris, Université de Paris Sorbonne, Paris, France.
Aurélie MartinDepartment of Infectious and Tropical Diseases, CHU Nîmes, University of Montpellier, Nîmes, France.
Vincent DubeeDepartment of Infectious Diseases, University Hospital of Angers, Angers, France.
Jérôme FreyService des Urgences, Hôpital de Mercy - CHR Metz Thionville, France.
Audrey Le BotInfectious Diseases and Intensive Care Unit, Pontchaillou University Hospital, Rennes, France.
Charles CazanaveCHU de Bordeaux, Infectious and Tropical Diseases Department, Bordeaux, France; University of Bordeaux, Microbiologie Fondamentale et Pathogénicité, Antimicrobial Resistance in Mycoplasmas and Gram-Negative Bacteria, Bordeaux, France.
Philippe PetuaIntensive Care Unit, Tarbes Hospital, Tarbes, France.
Roland LiblauInstitut Toulousain des Maladies Infectieuses et Inflammatoires (Infinity) INSERM, Université Toulouse III., Toulouse, France.
Fabrice CarratSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique (IPLESP), Paris, France; Unité de Santé Publique, Hôpital Saint Antoine, Paris, France.
Youri YordanovSorbonne Université, Hôpital Saint Antoine, Service d'Accueil des Urgences, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France.
Institut Pierre Louis d‘Épidémiologie et de Santé Publique · FRAgence Nationale de Recherches sur le Sida et les Hépatites Virales · FRAssistance Publique – Hôpitaux de Paris · FRCentre Hospitalier Sud Francilien · FRInserm · FRPitié-Salpêtrière Hospital · FRSorbonne Université · FRCentre d'Immunologie et des Maladies Infectieuses · FRCentre d'Investigation Clinique de Nantes · FRCentre Hospitalier Agen - Nérac · FRCentre Hospitalier de Bigorre · FRCentre Hospitalier Régional de Metz-Thionville · FRCentre Hospitalier Universitaire de Bordeaux · FRCentre Hospitalier Universitaire de Poitiers · FRCentre Hospitalier Universitaire de Rennes · FRCHU Dijon Bourgogne · FRHôpital Bichat-Claude-Bernard · FRHôpital Tenon · FRInstitut Toulousain des Maladies Infectieuses et InflammatoiresiXBlue (France) · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesOur aim was to compare the clinical and virological outcomes in Omicron BA.1- and BA.2-infected patients who received sotrovimab with those in patients who received nirmatrelvir for the prevention of severe COVID-19.

methodsIn this multi-centric, prospective ANRS 0003S CoCoPrev cohort study, patients at a high risk of progression of mild-to-moderate BA.1 or BA.2 COVID-19 who received sotrovimab or nirmatrelvir were included. The proportion of patients with progression to severe COVID-19, time between the start of treatment to negative PCR conversion, SARS-CoV-2 viral decay, and characterization of resistance variants were determined. A multi-variable Cox proportional hazard model was used to determine the time to negative PCR conversion and a mixed-effect model for the dynamics of viral decay.

resultsAmongst 255 included patients, 199 (80%) received ≥3 vaccine doses, 195 (76%) received sotrovimab, and 60 (24%) received nirmatrelvir. On day 28, new COVID-19-related hospitalization occurred in 4 of 193 (2%; 95% CI, 1-5%) sotrovimab-treated patients and 0 of 55 nirmatrelvir-treated patients (p 0.24). One out of the 55 nirmatrelvir-treated patients died (2%; 95% CI, 0-10%). The median time to negative PCR conversion was 11.5 days (95% CI, 10.5-13) in the sotrovimab-treated patients vs. 4 days (95% CI, 4-9) in the nirmatrelvir-treated patients (p < 0.001). Viral decay was faster in the patients who received nirmatrelvir (p < 0.001). In the multi-variable analysis, nirmatrelvir and nasopharyngeal PCR cycle threshold values were independently associated with faster conversion to negative PCR (hazard ratio, 2.35; 95% CI, 1.56-3.56; p < 0.0001 and hazard ratio, 1.05; 95% CI, 1.01-1.08; p 0.01, respectively).

conclusionsEarly administration of nirmatrelvir in high-risk patients compared with that of sotrovimab was associated with faster viral clearance. This may participate to decrease transmission and prevent viral resistance.

Indexed as

COVID-19Antibodies, Monoclonal, HumanizedAntibodies, NeutralizingCohort StudiesCOVID-19 TestingHumansLactamsLeucineNitrilesPolymerase Chain ReactionProspective StudiesSARS-CoV-2Antibodies, Monoclonal, HumanizedAntibodies, NeutralizingLactamsLeucineNitrilessotrovimabAnti-viral treatmentCOVID-19Monoclonal antibodiesNirmatrelvirSotrovimab

Identifiers

PMID36586513
PMCPMC9794519
OpenAlexW4313420924

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.