Evidence map›Paper›PMID 36851654›Full record

ArticleViruses2023

Safety and Efficacy of Outpatient Treatments for COVID-19: Real-Life Data from a Regionwide Cohort of High-Risk Patients in Tuscany, Italy (the FEDERATE Cohort).

Tommaso Manciulli, Michele Spinicci, Barbara Rossetti, Roberta Maria Antonello, Filippo Lagi, Anna Barbiero, Flavia Chechi, Giuseppe Formica, Emanuela Francalanci, Mirco Alesi and 27 more

Open access · goldAbstract readMulticenter Study
In one paragraph

Article in Viruses, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 4 pooled it
3.3field-weighted citation impact, top 7% 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.

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

13 citing papers in PubMed, 4 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
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  5. Review
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  7. Article
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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

37 authors at 10 institutions in 1 country.

Tommaso ManciulliDipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, 50121 Firenze, Italy.
Michele SpinicciDipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, 50121 Firenze, Italy.ORCID 0000-0002-5377-7118
Barbara RossettiUOC Malattie Infettive, Ospedale Misericordia, 58100 Grosseto, Italy.
Roberta Maria AntonelloDipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, 50121 Firenze, Italy.ORCID 0000-0003-1533-441X
Filippo LagiDipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, 50121 Firenze, Italy.
Anna BarbieroDipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, 50121 Firenze, Italy.
Flavia ChechiDipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, 50121 Firenze, Italy.
Giuseppe FormicaDipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, 50121 Firenze, Italy.
Emanuela FrancalanciDipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, 50121 Firenze, Italy.
Mirco AlesiDipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, 50121 Firenze, Italy.
Samuele GaggioliDipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, 50121 Firenze, Italy.
Giulia ModiDipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, 50121 Firenze, Italy.ORCID 0000-0002-8958-0755
Sara ModicaSOC Malattie Infettive ed Epatologia, Ospedale San Luca, 55100 Lucca, Italy.
Riccardo PaggiDipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, 50121 Firenze, Italy.ORCID 0000-0001-8767-2640
Cecilia CostaUO Malattie Infettive, Ospedale Santa Maria Annunziata, 50012 Firenze, Italy.
Alessandra MoreaUO Malattie Infettive, Ospedali Riuniti di Livorno, 57124 Livorno, Italy.
Lorenzo PaglicciUO Malattie Infettive, Ospedale San Donato, 52100 Arezzo, Italy.
Ilaria RancanDipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, 50121 Firenze, Italy.
Francesco AmadoriUO Malattie Infettive, Ospedale Apuane, 54100 Massa, Italy.
Agnese TamborrinoDipartimento Scienze della Salute, Università degli Studi di Firenze, 50139 Firenze, Italy.
Marta TilliDipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, 50121 Firenze, Italy.ORCID 0000-0002-2097-2443
Giulia BandiniDipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, 50121 Firenze, Italy.
Alberto Moggi PignoneDipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, 50121 Firenze, Italy.
Beatrice ValorianiUO Malattie Infettive, Ospedale San Donato, 52100 Arezzo, Italy.
Francesca MontagnaniDipartimento di Biotecnologie Mediche, Università degli Studi di Siena, 53100 Siena, Italy.ORCID 0000-0002-2267-1337
Mario TumbarelloDipartimento di Biotecnologie Mediche, Università degli Studi di Siena, 53100 Siena, Italy.ORCID 0000-0002-9519-8552
Pierluigi BlancSOC Malattie Infettive, Ospedale San Jacopo, 51100 Pistoia, Italy.
Massimo Di PietroUO Malattie Infettive, Ospedale Santa Maria Annunziata, 50012 Firenze, Italy.
Luisa GalliDipartimento Scienze della Salute, Università degli Studi di Firenze, 50139 Firenze, Italy.ORCID 0000-0002-7912-3366
Donatella AquiliniUO Malattie Infettive, Ospedale Santo Stefano, 59100 Prato, Italy.
Antonella VincentiUO Malattie Infettive, Ospedale Apuane, 54100 Massa, Italy.
Spartaco SaniUO Malattie Infettive, Ospedali Riuniti di Livorno, 57124 Livorno, Italy.
Cesira NencioniUOC Malattie Infettive, Ospedale Misericordia, 58100 Grosseto, Italy.
Sauro LuchiSOC Malattie Infettive ed Epatologia, Ospedale San Luca, 55100 Lucca, Italy.
Danilo TacconiUO Malattie Infettive, Ospedale San Donato, 52100 Arezzo, Italy.
Lorenzo ZammarchiDipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, 50121 Firenze, Italy.ORCID 0000-0003-0892-8404
Alessandro BartoloniDipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, 50121 Firenze, Italy.ORCID 0000-0001-9758-1523
University of Florence · ITAzienda Ospedaliero-Universitaria Careggi · ITOspedale Santa Maria Annunziata · ITOspedale del Ceppo · ITOspedale di Prato Santo Stefano · ITOspedale San Donato · ITUniversity of Siena · ITOspedale di Livorno · ITOspedale Misericordia - Grosseto · ITMeyer Children's Hospital · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Early COVID-19 treatments can prevent progression to severe disease. However, real-life data are still limited, and studies are warranted to monitor the efficacy and tolerability of these drugs. We retrospectively enrolled outpatients receiving early treatment for COVID-19 in 11 infectious diseases units in the Tuscany region of Italy between 1 January and 31 March 2022, when Omicron sublineages BA.1 and BA.2 were circulating. Eligible COVID-19 patients were treated with sotrovimab (SOT), remdesivir (RMD), nirmatrelvir/ritonavir (NRM/r), or molnupiravir (MOL). We gathered demographic and clinical features, 28-day outcomes (hospitalization or death), and drugs tolerability. A total of 781 patients (median age 69.9, 66% boosted for SARS-CoV-2) met the inclusion criteria, of whom 314 were treated with SOT (40.2%), 205 with MOL (26.3%), 142 with RMD (18.2%), and 120 with NRM/r (15.4%). Overall, 28-day hospitalization and death occurred in 18/781 (2.3%) and 3/781 (0.3%), respectively. Multivariable Cox regression showed that patients receiving SOT had a reduced risk of meeting the composite outcome (28-day hospitalization and/or death) in comparison to the RMD cohort, while no significant differences were evidenced for the MOL and NRM/r groups in comparison to the RMD group. Other predictors of negative outcomes included cancer, chronic kidney disease, and a time between symptoms onset and treatment administration > 3 days. All treatments showed good safety and tolerability, with only eight patients (1%) whose treatment was interrupted due to intolerance. In the first Italian multicenter study presenting real-life data on COVID-19 early treatments, all regimens demonstrated good safety and efficacy. SOT showed a reduced risk of progression versus RMD. No significant differences of outcome were observed in preventing 28-day hospitalization and death among patients treated with RMD, MOL, and NRM/r.

Indexed as

COVID-19OutpatientsAgedHumansItalyRetrospective StudiesSARS-CoV-2COVID-19molnupiravirnirmatrelvir/ritonavirremdesivirSARS-CoV-2sotrovimab

Identifiers

PMID36851654
PMCPMC9967010
OpenAlexW4319318146

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Registered trials

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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.