Early administration of lopinavir/ritonavir plus hydroxychloroquine does not alter the clinical course of SARS-CoV-2 infection: A retrospective cohort study.
Identifieur interne : 000F18 ( Main/Corpus ); précédent : 000F17; suivant : 000F19Early administration of lopinavir/ritonavir plus hydroxychloroquine does not alter the clinical course of SARS-CoV-2 infection: A retrospective cohort study.
Auteurs : Andrea Giacomelli ; Gabriele Pagani ; Anna L. Ridolfo ; Letizia Oreni ; Federico Conti ; Laura Pezzati ; Lucia Bradanini ; Giacomo Casalini ; Cinzia Bassoli ; Valentina Morena ; Simone Passerini ; Giuliano Rizzardini ; Chiara Cogliati ; Elisa Ceriani ; Riccardo Colombo ; Stefano Rusconi ; Cristina Gervasoni ; Dario Cattaneo ; Spinello Antinori ; Massimo GalliSource :
- Journal of medical virology [ 1096-9071 ] ; 2021.
English descriptors
- KwdEn :
- Aged (MeSH), Antiviral Agents (therapeutic use), COVID-19 (drug therapy), Drug Combinations (MeSH), Female (MeSH), Humans (MeSH), Hydroxychloroquine (therapeutic use), Italy (MeSH), Lopinavir (therapeutic use), Male (MeSH), Middle Aged (MeSH), Retrospective Studies (MeSH), Ritonavir (therapeutic use), SARS-CoV-2 (drug effects).
- MESH :
- chemical , therapeutic use : Antiviral Agents, Hydroxychloroquine, Lopinavir, Ritonavir.
- geographic : Italy.
- drug effects : SARS-CoV-2.
- drug therapy : COVID-19.
- Aged, Drug Combinations, Female, Humans, Male, Middle Aged, Retrospective Studies.
Abstract
As it has been shown that lopinavir (LPV) and hydroxychloroquine (HCQ) have in vitro activity against coronaviruses, they were used to treat COVID-19 during the first wave of the epidemic in Lombardy, Italy. To compare the rate of clinical improvement between those who started LPV/ritonavir (LPV/r)+HCQ within 5 days of symptom onset (early treatment, ET) and those who started later (delayed treatment, DT). This was a retrospective intent-to-treat analysis of the hospitalized patients who started LPV/r + HCQ between 21 February and 20 March 2020. The association between the timing of treatment and the probability of 30-day mortality was assessed using univariable and multivariable logistic models. The study involved 172 patients: 43 (25%) in the ET and 129 (75%) in the DT group. The rate of clinical improvement increased over time to 73.3% on day 30, without any significant difference between the two groups (Gray's test P = .213). After adjusting for potentially relevant clinical variables, there was no significant association between the timing of the start of treatment and the probability of 30-day mortality (adjusted odds ratio [aOR] ET vs DT = 1.45, 95% confidence interval 0.50-4.19). Eight percent of the patients discontinued the treatment becausebecause of severe gastrointestinal disorders attributable to LPV/r. The timing of the start of LPV/r + HCQ treatment does not seem to affect the clinical course of hospitalized patients with COVID-19. Together with the severe adverse events attributable to LPV/r, this raises concerns about the benefit of using this combination to treat COVID-19.
DOI: 10.1002/jmv.26407
PubMed: 32776534
PubMed Central: PMC7436522
Links to Exploration step
pubmed:32776534Le document en format XML
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<author><name sortKey="Giacomelli, Andrea" sort="Giacomelli, Andrea" uniqKey="Giacomelli A" first="Andrea" last="Giacomelli">Andrea Giacomelli</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
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<affiliation><nlm:affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</nlm:affiliation>
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<author><name sortKey="Pagani, Gabriele" sort="Pagani, Gabriele" uniqKey="Pagani G" first="Gabriele" last="Pagani">Gabriele Pagani</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
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<affiliation><nlm:affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</nlm:affiliation>
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<author><name sortKey="Ridolfo, Anna L" sort="Ridolfo, Anna L" uniqKey="Ridolfo A" first="Anna L" last="Ridolfo">Anna L. Ridolfo</name>
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<author><name sortKey="Oreni, Letizia" sort="Oreni, Letizia" uniqKey="Oreni L" first="Letizia" last="Oreni">Letizia Oreni</name>
<affiliation><nlm:affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</nlm:affiliation>
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<author><name sortKey="Conti, Federico" sort="Conti, Federico" uniqKey="Conti F" first="Federico" last="Conti">Federico Conti</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
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<affiliation><nlm:affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</nlm:affiliation>
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<author><name sortKey="Pezzati, Laura" sort="Pezzati, Laura" uniqKey="Pezzati L" first="Laura" last="Pezzati">Laura Pezzati</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
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<affiliation><nlm:affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</nlm:affiliation>
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<author><name sortKey="Bradanini, Lucia" sort="Bradanini, Lucia" uniqKey="Bradanini L" first="Lucia" last="Bradanini">Lucia Bradanini</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
<affiliation><nlm:affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</nlm:affiliation>
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<author><name sortKey="Casalini, Giacomo" sort="Casalini, Giacomo" uniqKey="Casalini G" first="Giacomo" last="Casalini">Giacomo Casalini</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
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<affiliation><nlm:affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</nlm:affiliation>
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<author><name sortKey="Bassoli, Cinzia" sort="Bassoli, Cinzia" uniqKey="Bassoli C" first="Cinzia" last="Bassoli">Cinzia Bassoli</name>
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<affiliation><nlm:affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</nlm:affiliation>
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<author><name sortKey="Morena, Valentina" sort="Morena, Valentina" uniqKey="Morena V" first="Valentina" last="Morena">Valentina Morena</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
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<affiliation><nlm:affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</nlm:affiliation>
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<author><name sortKey="Passerini, Simone" sort="Passerini, Simone" uniqKey="Passerini S" first="Simone" last="Passerini">Simone Passerini</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
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<author><name sortKey="Rizzardini, Giuliano" sort="Rizzardini, Giuliano" uniqKey="Rizzardini G" first="Giuliano" last="Rizzardini">Giuliano Rizzardini</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
<affiliation><nlm:affiliation>School of Clinical Medicine, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Cogliati, Chiara" sort="Cogliati, Chiara" uniqKey="Cogliati C" first="Chiara" last="Cogliati">Chiara Cogliati</name>
<affiliation><nlm:affiliation>Department of Internal Medicine, ASST Fatebenefratelli-Sacco, Luigi Sacco Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Ceriani, Elisa" sort="Ceriani, Elisa" uniqKey="Ceriani E" first="Elisa" last="Ceriani">Elisa Ceriani</name>
<affiliation><nlm:affiliation>Department of Internal Medicine, ASST Fatebenefratelli-Sacco, Luigi Sacco Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Colombo, Riccardo" sort="Colombo, Riccardo" uniqKey="Colombo R" first="Riccardo" last="Colombo">Riccardo Colombo</name>
<affiliation><nlm:affiliation>Department of Anesthesiology and Intensive Care, ASST Fatebenefratelli-Sacco, Luigi Sacco Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Rusconi, Stefano" sort="Rusconi, Stefano" uniqKey="Rusconi S" first="Stefano" last="Rusconi">Stefano Rusconi</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
<affiliation><nlm:affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Gervasoni, Cristina" sort="Gervasoni, Cristina" uniqKey="Gervasoni C" first="Cristina" last="Gervasoni">Cristina Gervasoni</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Cattaneo, Dario" sort="Cattaneo, Dario" uniqKey="Cattaneo D" first="Dario" last="Cattaneo">Dario Cattaneo</name>
<affiliation><nlm:affiliation>Unit of Clinical Pharmacology, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Antinori, Spinello" sort="Antinori, Spinello" uniqKey="Antinori S" first="Spinello" last="Antinori">Spinello Antinori</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
<affiliation><nlm:affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</nlm:affiliation>
</affiliation>
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<author><name sortKey="Galli, Massimo" sort="Galli, Massimo" uniqKey="Galli M" first="Massimo" last="Galli">Massimo Galli</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
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<affiliation><nlm:affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</nlm:affiliation>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Early administration of lopinavir/ritonavir plus hydroxychloroquine does not alter the clinical course of SARS-CoV-2 infection: A retrospective cohort study.</title>
<author><name sortKey="Giacomelli, Andrea" sort="Giacomelli, Andrea" uniqKey="Giacomelli A" first="Andrea" last="Giacomelli">Andrea Giacomelli</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
<affiliation><nlm:affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</nlm:affiliation>
</affiliation>
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<author><name sortKey="Pagani, Gabriele" sort="Pagani, Gabriele" uniqKey="Pagani G" first="Gabriele" last="Pagani">Gabriele Pagani</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
<affiliation><nlm:affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</nlm:affiliation>
</affiliation>
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<author><name sortKey="Ridolfo, Anna L" sort="Ridolfo, Anna L" uniqKey="Ridolfo A" first="Anna L" last="Ridolfo">Anna L. Ridolfo</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Oreni, Letizia" sort="Oreni, Letizia" uniqKey="Oreni L" first="Letizia" last="Oreni">Letizia Oreni</name>
<affiliation><nlm:affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Conti, Federico" sort="Conti, Federico" uniqKey="Conti F" first="Federico" last="Conti">Federico Conti</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
<affiliation><nlm:affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</nlm:affiliation>
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<author><name sortKey="Pezzati, Laura" sort="Pezzati, Laura" uniqKey="Pezzati L" first="Laura" last="Pezzati">Laura Pezzati</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
<affiliation><nlm:affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Bradanini, Lucia" sort="Bradanini, Lucia" uniqKey="Bradanini L" first="Lucia" last="Bradanini">Lucia Bradanini</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
<affiliation><nlm:affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Casalini, Giacomo" sort="Casalini, Giacomo" uniqKey="Casalini G" first="Giacomo" last="Casalini">Giacomo Casalini</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
<affiliation><nlm:affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Bassoli, Cinzia" sort="Bassoli, Cinzia" uniqKey="Bassoli C" first="Cinzia" last="Bassoli">Cinzia Bassoli</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
<affiliation><nlm:affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Morena, Valentina" sort="Morena, Valentina" uniqKey="Morena V" first="Valentina" last="Morena">Valentina Morena</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
<affiliation><nlm:affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Passerini, Simone" sort="Passerini, Simone" uniqKey="Passerini S" first="Simone" last="Passerini">Simone Passerini</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Rizzardini, Giuliano" sort="Rizzardini, Giuliano" uniqKey="Rizzardini G" first="Giuliano" last="Rizzardini">Giuliano Rizzardini</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
<affiliation><nlm:affiliation>School of Clinical Medicine, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Cogliati, Chiara" sort="Cogliati, Chiara" uniqKey="Cogliati C" first="Chiara" last="Cogliati">Chiara Cogliati</name>
<affiliation><nlm:affiliation>Department of Internal Medicine, ASST Fatebenefratelli-Sacco, Luigi Sacco Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Ceriani, Elisa" sort="Ceriani, Elisa" uniqKey="Ceriani E" first="Elisa" last="Ceriani">Elisa Ceriani</name>
<affiliation><nlm:affiliation>Department of Internal Medicine, ASST Fatebenefratelli-Sacco, Luigi Sacco Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Colombo, Riccardo" sort="Colombo, Riccardo" uniqKey="Colombo R" first="Riccardo" last="Colombo">Riccardo Colombo</name>
<affiliation><nlm:affiliation>Department of Anesthesiology and Intensive Care, ASST Fatebenefratelli-Sacco, Luigi Sacco Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Rusconi, Stefano" sort="Rusconi, Stefano" uniqKey="Rusconi S" first="Stefano" last="Rusconi">Stefano Rusconi</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
<affiliation><nlm:affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Gervasoni, Cristina" sort="Gervasoni, Cristina" uniqKey="Gervasoni C" first="Cristina" last="Gervasoni">Cristina Gervasoni</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Cattaneo, Dario" sort="Cattaneo, Dario" uniqKey="Cattaneo D" first="Dario" last="Cattaneo">Dario Cattaneo</name>
<affiliation><nlm:affiliation>Unit of Clinical Pharmacology, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Antinori, Spinello" sort="Antinori, Spinello" uniqKey="Antinori S" first="Spinello" last="Antinori">Spinello Antinori</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
<affiliation><nlm:affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Galli, Massimo" sort="Galli, Massimo" uniqKey="Galli M" first="Massimo" last="Galli">Massimo Galli</name>
<affiliation><nlm:affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</nlm:affiliation>
</affiliation>
<affiliation><nlm:affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</nlm:affiliation>
</affiliation>
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<series><title level="j">Journal of medical virology</title>
<idno type="eISSN">1096-9071</idno>
<imprint><date when="2021" type="published">2021</date>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged (MeSH)</term>
<term>Antiviral Agents (therapeutic use)</term>
<term>COVID-19 (drug therapy)</term>
<term>Drug Combinations (MeSH)</term>
<term>Female (MeSH)</term>
<term>Humans (MeSH)</term>
<term>Hydroxychloroquine (therapeutic use)</term>
<term>Italy (MeSH)</term>
<term>Lopinavir (therapeutic use)</term>
<term>Male (MeSH)</term>
<term>Middle Aged (MeSH)</term>
<term>Retrospective Studies (MeSH)</term>
<term>Ritonavir (therapeutic use)</term>
<term>SARS-CoV-2 (drug effects)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiviral Agents</term>
<term>Hydroxychloroquine</term>
<term>Lopinavir</term>
<term>Ritonavir</term>
</keywords>
<keywords scheme="MESH" type="geographic" xml:lang="en"><term>Italy</term>
</keywords>
<keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>SARS-CoV-2</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>COVID-19</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Aged</term>
<term>Drug Combinations</term>
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<front><div type="abstract" xml:lang="en">As it has been shown that lopinavir (LPV) and hydroxychloroquine (HCQ) have in vitro activity against coronaviruses, they were used to treat COVID-19 during the first wave of the epidemic in Lombardy, Italy. To compare the rate of clinical improvement between those who started LPV/ritonavir (LPV/r)+HCQ within 5 days of symptom onset (early treatment, ET) and those who started later (delayed treatment, DT). This was a retrospective intent-to-treat analysis of the hospitalized patients who started LPV/r + HCQ between 21 February and 20 March 2020. The association between the timing of treatment and the probability of 30-day mortality was assessed using univariable and multivariable logistic models. The study involved 172 patients: 43 (25%) in the ET and 129 (75%) in the DT group. The rate of clinical improvement increased over time to 73.3% on day 30, without any significant difference between the two groups (Gray's test P = .213). After adjusting for potentially relevant clinical variables, there was no significant association between the timing of the start of treatment and the probability of 30-day mortality (adjusted odds ratio [aOR] ET vs DT = 1.45, 95% confidence interval 0.50-4.19). Eight percent of the patients discontinued the treatment becausebecause of severe gastrointestinal disorders attributable to LPV/r. The timing of the start of LPV/r + HCQ treatment does not seem to affect the clinical course of hospitalized patients with COVID-19. Together with the severe adverse events attributable to LPV/r, this raises concerns about the benefit of using this combination to treat COVID-19.</div>
</front>
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<Title>Journal of medical virology</Title>
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<ArticleTitle>Early administration of lopinavir/ritonavir plus hydroxychloroquine does not alter the clinical course of SARS-CoV-2 infection: A retrospective cohort study.</ArticleTitle>
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</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1002/jmv.26407</ELocationID>
<Abstract><AbstractText>As it has been shown that lopinavir (LPV) and hydroxychloroquine (HCQ) have in vitro activity against coronaviruses, they were used to treat COVID-19 during the first wave of the epidemic in Lombardy, Italy. To compare the rate of clinical improvement between those who started LPV/ritonavir (LPV/r)+HCQ within 5 days of symptom onset (early treatment, ET) and those who started later (delayed treatment, DT). This was a retrospective intent-to-treat analysis of the hospitalized patients who started LPV/r + HCQ between 21 February and 20 March 2020. The association between the timing of treatment and the probability of 30-day mortality was assessed using univariable and multivariable logistic models. The study involved 172 patients: 43 (25%) in the ET and 129 (75%) in the DT group. The rate of clinical improvement increased over time to 73.3% on day 30, without any significant difference between the two groups (Gray's test P = .213). After adjusting for potentially relevant clinical variables, there was no significant association between the timing of the start of treatment and the probability of 30-day mortality (adjusted odds ratio [aOR] ET vs DT = 1.45, 95% confidence interval 0.50-4.19). Eight percent of the patients discontinued the treatment becausebecause of severe gastrointestinal disorders attributable to LPV/r. The timing of the start of LPV/r + HCQ treatment does not seem to affect the clinical course of hospitalized patients with COVID-19. Together with the severe adverse events attributable to LPV/r, this raises concerns about the benefit of using this combination to treat COVID-19.</AbstractText>
<CopyrightInformation>© 2020 Wiley Periodicals LLC.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Giacomelli</LastName>
<ForeName>Andrea</ForeName>
<Initials>A</Initials>
<Identifier Source="ORCID">0000-0003-3685-4289</Identifier>
<AffiliationInfo><Affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Pagani</LastName>
<ForeName>Gabriele</ForeName>
<Initials>G</Initials>
<Identifier Source="ORCID">0000-0002-1668-7543</Identifier>
<AffiliationInfo><Affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ridolfo</LastName>
<ForeName>Anna L</ForeName>
<Initials>AL</Initials>
<AffiliationInfo><Affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Oreni</LastName>
<ForeName>Letizia</ForeName>
<Initials>L</Initials>
<AffiliationInfo><Affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Conti</LastName>
<ForeName>Federico</ForeName>
<Initials>F</Initials>
<AffiliationInfo><Affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Pezzati</LastName>
<ForeName>Laura</ForeName>
<Initials>L</Initials>
<AffiliationInfo><Affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Bradanini</LastName>
<ForeName>Lucia</ForeName>
<Initials>L</Initials>
<AffiliationInfo><Affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Casalini</LastName>
<ForeName>Giacomo</ForeName>
<Initials>G</Initials>
<AffiliationInfo><Affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Bassoli</LastName>
<ForeName>Cinzia</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Morena</LastName>
<ForeName>Valentina</ForeName>
<Initials>V</Initials>
<AffiliationInfo><Affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Passerini</LastName>
<ForeName>Simone</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Rizzardini</LastName>
<ForeName>Giuliano</ForeName>
<Initials>G</Initials>
<AffiliationInfo><Affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>School of Clinical Medicine, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Cogliati</LastName>
<ForeName>Chiara</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>Department of Internal Medicine, ASST Fatebenefratelli-Sacco, Luigi Sacco Hospital, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ceriani</LastName>
<ForeName>Elisa</ForeName>
<Initials>E</Initials>
<AffiliationInfo><Affiliation>Department of Internal Medicine, ASST Fatebenefratelli-Sacco, Luigi Sacco Hospital, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Colombo</LastName>
<ForeName>Riccardo</ForeName>
<Initials>R</Initials>
<AffiliationInfo><Affiliation>Department of Anesthesiology and Intensive Care, ASST Fatebenefratelli-Sacco, Luigi Sacco Hospital, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Rusconi</LastName>
<ForeName>Stefano</ForeName>
<Initials>S</Initials>
<Identifier Source="ORCID">0000-0002-0375-9990</Identifier>
<AffiliationInfo><Affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Gervasoni</LastName>
<ForeName>Cristina</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Cattaneo</LastName>
<ForeName>Dario</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Unit of Clinical Pharmacology, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Antinori</LastName>
<ForeName>Spinello</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Galli</LastName>
<ForeName>Massimo</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Luigi Sacco Department of Biomedical and Clinical Sciences DIBIC, University of Milan, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2020</Year>
<Month>09</Month>
<Day>28</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>United States</Country>
<MedlineTA>J Med Virol</MedlineTA>
<NlmUniqueID>7705876</NlmUniqueID>
<ISSNLinking>0146-6615</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList><Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D000998">Antiviral Agents</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D004338">Drug Combinations</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>2494G1JF75</RegistryNumber>
<NameOfSubstance UI="D061466">Lopinavir</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>4QWG6N8QKH</RegistryNumber>
<NameOfSubstance UI="D006886">Hydroxychloroquine</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>O3J8G9O825</RegistryNumber>
<NameOfSubstance UI="D019438">Ritonavir</NameOfSubstance>
</Chemical>
</ChemicalList>
<SupplMeshList><SupplMeshName Type="Protocol" UI="C000705127">COVID-19 drug treatment</SupplMeshName>
</SupplMeshList>
<CitationSubset>IM</CitationSubset>
<MeshHeadingList><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000998" MajorTopicYN="N">Antiviral Agents</DescriptorName>
<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000086382" MajorTopicYN="N">COVID-19</DescriptorName>
<QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D004338" MajorTopicYN="N">Drug Combinations</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006886" MajorTopicYN="N">Hydroxychloroquine</DescriptorName>
<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D007558" MajorTopicYN="N" Type="Geographic">Italy</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D061466" MajorTopicYN="N">Lopinavir</DescriptorName>
<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D012189" MajorTopicYN="N">Retrospective Studies</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D019438" MajorTopicYN="N">Ritonavir</DescriptorName>
<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000086402" MajorTopicYN="N">SARS-CoV-2</DescriptorName>
<QualifierName UI="Q000187" MajorTopicYN="Y">drug effects</QualifierName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">COVID-19</Keyword>
<Keyword MajorTopicYN="Y">antiviral treatment</Keyword>
<Keyword MajorTopicYN="Y">early</Keyword>
<Keyword MajorTopicYN="Y">hydroxychloroquine</Keyword>
<Keyword MajorTopicYN="Y">lopinavir</Keyword>
<Keyword MajorTopicYN="Y">mortality</Keyword>
</KeywordList>
</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year>
<Month>06</Month>
<Day>16</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted"><Year>2020</Year>
<Month>08</Month>
<Day>03</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="pubmed"><Year>2020</Year>
<Month>8</Month>
<Day>11</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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<PubMedPubDate PubStatus="medline"><Year>2021</Year>
<Month>3</Month>
<Day>9</Day>
<Hour>6</Hour>
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<Month>8</Month>
<Day>11</Day>
<Hour>6</Hour>
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<PublicationStatus>ppublish</PublicationStatus>
<ArticleIdList><ArticleId IdType="pubmed">32776534</ArticleId>
<ArticleId IdType="doi">10.1002/jmv.26407</ArticleId>
<ArticleId IdType="pmc">PMC7436522</ArticleId>
</ArticleIdList>
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