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Comparison of hydroxychloroquine, lopinavir/ritonavir, and standard of care in critically ill patients with SARS-CoV-2 pneumonia: an opportunistic retrospective analysis.
Crit Care. 2020 07 11; 24(1):418.CC

Abstract

BACKGROUND

The severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) outbreak is spreading worldwide. To date, no specific treatment has convincingly demonstrated its efficacy. Hydroxychloroquine and lopinavir/ritonavir have potential interest, but virological and clinical data are scarce, especially in critically ill patients.

METHODS

The present report took the opportunity of compassionate use and successive drug shortages to compare the effects of two therapeutic options, lopinavir/ritonavir and hydroxychloroquine, as compared to standard of care only. The primary outcomes were treatment escalation (intubation, extra-corporeal membrane oxygenation support, or renal replacement therapy) after day 1 until day 28. Secondary outcomes included ventilator-free days at day 28, mortality at day 14 and day 28, treatment safety issues and changes in respiratory tracts, and plasma viral load (as estimated by cycle threshold value) between admission and day 7.

RESULTS

Eighty patients were treated during a 4-week period and included in the analysis: 22 (28%) received standard of care only, 20 (25%) patients received lopinavir/ritonavir associated to standard of care, and 38 (47%) patients received hydroxychloroquine and standard of care. Baseline characteristics were well balanced between the 3 groups. Treatment escalation occurred in 9 (41%), 10 (50%), and 15 (39%) patients who received standard of care only, standard of care and lopinavir/ritonavir, and standard of care and hydroxychloroquine, respectively (p = 0.567). There was no significant difference between groups regarding the number of ventilator-free days at day 28 and mortality at day 14 and day 28. Finally, there was no significant change between groups in viral respiratory or plasma load between admission and day 7.

CONCLUSION

In critically ill patients admitted for SARS-CoV-2-related pneumonia, no difference was found between hydroxychloroquine or lopinavir/ritonavir as compared to standard of care only on the proportion of patients who needed treatment escalation at day 28. Further randomized controlled trials are required to demonstrate whether these drugs may be useful in this context.

Authors+Show Affiliations

AP-HP. Sorbonne Université, Hôpital Pitié-Salpêtrière, Service de Pneumologie, Médecine intensive - Réanimation (Département "R3S"), Paris, France. marie.lecronier@aphp.fr.AP-HP. Sorbonne Université, Hôpital Pitié-Salpêtrière, Service de Pneumologie, Médecine intensive - Réanimation (Département "R3S"), Paris, France. Sorbonne Université, INSERM, UMR_S 1158 Neurophysiologie respiratoire expérimentale et clinique, Paris, France.Sorbonne Université, INSERM UMR S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Team 3 THERAVIR, Paris, France. AP-HP. Sorbonne Université, Hôpital Pitié-Salpêtrière, Service de Virologie, Centre National de Référence Herpès virus, Paris, France.AP-HP. Sorbonne Université, Hôpital Pitié-Salpêtrière, Service de Pneumologie, Médecine intensive - Réanimation (Département "R3S"), Paris, France.AP-HP. Sorbonne Université, Hôpital Pitié-Salpêtrière, Service de Pneumologie, Médecine intensive - Réanimation (Département "R3S"), Paris, France.AP-HP. Sorbonne Université, Hôpital Pitié-Salpêtrière, Service de Pneumologie, Médecine intensive - Réanimation (Département "R3S"), Paris, France.AP-HP. Sorbonne Université, Hôpital Pitié-Salpêtrière, Service de Pneumologie, Médecine intensive - Réanimation (Département "R3S"), Paris, France.AP-HP. Sorbonne Université, Hôpital Pitié-Salpêtrière, Service de Pneumologie, Médecine intensive - Réanimation (Département "R3S"), Paris, France.AP-HP. Sorbonne Université, Hôpital Pitié-Salpêtrière, Service de Pneumologie, Médecine intensive - Réanimation (Département "R3S"), Paris, France. Sorbonne Université, INSERM, UMR_S 1158 Neurophysiologie respiratoire expérimentale et clinique, Paris, France.AP-HP. Sorbonne Université, Hôpital Pitié-Salpêtrière, Service de Pneumologie, Médecine intensive - Réanimation (Département "R3S"), Paris, France.AP-HP. Sorbonne Université, Hôpital Pitié-Salpêtrière, Département d'anesthésie réanimation, Paris, France.AP-HP. Sorbonne Université, Hôpital Pitié-Salpêtrière, Département d'anesthésie réanimation, Paris, France.AP-HP. Sorbonne Université, Hôpital Pitié-Salpêtrière, Département d'anesthésie réanimation, Paris, France.AP-HP. Sorbonne Université, Hôpital Pitié-Salpêtrière, Département d'anesthésie réanimation, Paris, France.AP-HP. Sorbonne Université, Hôpital Pitié-Salpêtrière, Département d'anesthésie réanimation, Paris, France.AP-HP. Sorbonne Université, Hôpital Pitié-Salpêtrière, Département d'anesthésie réanimation, Paris, France.AP-HP. Sorbonne Université, Hôpital Pitié-Salpêtrière, Département d'anesthésie réanimation, Paris, France.Sorbonne Université, INSERM UMR S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Team 3 THERAVIR, Paris, France. AP-HP. Sorbonne Université, Hôpital Pitié-Salpêtrière, Service de Virologie, Centre National de Référence Herpès virus, Paris, France.Sorbonne Université, INSERM, UMR_S 1158 Neurophysiologie respiratoire expérimentale et clinique, Paris, France. AP-HP. Sorbonne Université, Hôpital Pitié-Salpêtrière, Département d'anesthésie réanimation, Paris, France.AP-HP. Sorbonne Université, Hôpital Pitié-Salpêtrière, Service de Pneumologie, Médecine intensive - Réanimation (Département "R3S"), Paris, France.AP-HP. Sorbonne Université, Hôpital Pitié-Salpêtrière, Service de Pneumologie, Médecine intensive - Réanimation (Département "R3S"), Paris, France.AP-HP. Sorbonne Université, Hôpital Pitié-Salpêtrière, Service de Pneumologie, Médecine intensive - Réanimation (Département "R3S"), Paris, France. Sorbonne Université, INSERM, UMR_S 1158 Neurophysiologie respiratoire expérimentale et clinique, Paris, France.AP-HP. Sorbonne Université, Hôpital Pitié-Salpêtrière, Service de Pneumologie, Médecine intensive - Réanimation (Département "R3S"), Paris, France.AP-HP. Sorbonne Université, Hôpital Pitié-Salpêtrière, Service de Pneumologie, Médecine intensive - Réanimation (Département "R3S"), Paris, France.AP-HP. Sorbonne Université, Hôpital Pitié-Salpêtrière, Service de Pneumologie, Médecine intensive - Réanimation (Département "R3S"), Paris, France. Sorbonne Université, INSERM, UMR_S 1158 Neurophysiologie respiratoire expérimentale et clinique, Paris, France.AP-HP. Sorbonne Université, Hôpital Pitié-Salpêtrière, Service de Pneumologie, Médecine intensive - Réanimation (Département "R3S"), Paris, France. martin.dres@aphp.fr. Sorbonne Université, INSERM, UMR_S 1158 Neurophysiologie respiratoire expérimentale et clinique, Paris, France. martin.dres@aphp.fr.

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

32653015

Citation

Lecronier, Marie, et al. "Comparison of Hydroxychloroquine, Lopinavir/ritonavir, and Standard of Care in Critically Ill Patients With SARS-CoV-2 Pneumonia: an Opportunistic Retrospective Analysis." Critical Care (London, England), vol. 24, no. 1, 2020, p. 418.
Lecronier M, Beurton A, Burrel S, et al. Comparison of hydroxychloroquine, lopinavir/ritonavir, and standard of care in critically ill patients with SARS-CoV-2 pneumonia: an opportunistic retrospective analysis. Crit Care. 2020;24(1):418.
Lecronier, M., Beurton, A., Burrel, S., Haudebourg, L., Deleris, R., Le Marec, J., Virolle, S., Nemlaghi, S., Bureau, C., Mora, P., De Sarcus, M., Clovet, O., Duceau, B., Grisot, P. H., Pari, M. H., Arzoine, J., Clarac, U., Boutolleau, D., Raux, M., ... Dres, M. (2020). Comparison of hydroxychloroquine, lopinavir/ritonavir, and standard of care in critically ill patients with SARS-CoV-2 pneumonia: an opportunistic retrospective analysis. Critical Care (London, England), 24(1), 418. https://doi.org/10.1186/s13054-020-03117-9
Lecronier M, et al. Comparison of Hydroxychloroquine, Lopinavir/ritonavir, and Standard of Care in Critically Ill Patients With SARS-CoV-2 Pneumonia: an Opportunistic Retrospective Analysis. Crit Care. 2020 07 11;24(1):418. PubMed PMID: 32653015.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of hydroxychloroquine, lopinavir/ritonavir, and standard of care in critically ill patients with SARS-CoV-2 pneumonia: an opportunistic retrospective analysis. AU - Lecronier,Marie, AU - Beurton,Alexandra, AU - Burrel,Sonia, AU - Haudebourg,Luc, AU - Deleris,Robin, AU - Le Marec,Julien, AU - Virolle,Sara, AU - Nemlaghi,Safaa, AU - Bureau,Côme, AU - Mora,Pierre, AU - De Sarcus,Martin, AU - Clovet,Olivier, AU - Duceau,Baptiste, AU - Grisot,Paul Henri, AU - Pari,Marie Hélène, AU - Arzoine,Jérémy, AU - Clarac,Ulrich, AU - Boutolleau,David, AU - Raux,Mathieu, AU - Delemazure,Julie, AU - Faure,Morgane, AU - Decavele,Maxens, AU - Morawiec,Elise, AU - Mayaux,Julien, AU - Demoule,Alexandre, AU - Dres,Martin, Y1 - 2020/07/11/ PY - 2020/05/14/received PY - 2020/06/29/accepted PY - 2020/7/13/entrez PY - 2020/7/13/pubmed PY - 2020/7/16/medline KW - Hydroxychloroquine KW - Intensive care unit KW - Lopinavir/ritonavir KW - SARS-CoV-2 KW - Standard of care SP - 418 EP - 418 JF - Critical care (London, England) JO - Crit Care VL - 24 IS - 1 N2 - BACKGROUND: The severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) outbreak is spreading worldwide. To date, no specific treatment has convincingly demonstrated its efficacy. Hydroxychloroquine and lopinavir/ritonavir have potential interest, but virological and clinical data are scarce, especially in critically ill patients. METHODS: The present report took the opportunity of compassionate use and successive drug shortages to compare the effects of two therapeutic options, lopinavir/ritonavir and hydroxychloroquine, as compared to standard of care only. The primary outcomes were treatment escalation (intubation, extra-corporeal membrane oxygenation support, or renal replacement therapy) after day 1 until day 28. Secondary outcomes included ventilator-free days at day 28, mortality at day 14 and day 28, treatment safety issues and changes in respiratory tracts, and plasma viral load (as estimated by cycle threshold value) between admission and day 7. RESULTS: Eighty patients were treated during a 4-week period and included in the analysis: 22 (28%) received standard of care only, 20 (25%) patients received lopinavir/ritonavir associated to standard of care, and 38 (47%) patients received hydroxychloroquine and standard of care. Baseline characteristics were well balanced between the 3 groups. Treatment escalation occurred in 9 (41%), 10 (50%), and 15 (39%) patients who received standard of care only, standard of care and lopinavir/ritonavir, and standard of care and hydroxychloroquine, respectively (p = 0.567). There was no significant difference between groups regarding the number of ventilator-free days at day 28 and mortality at day 14 and day 28. Finally, there was no significant change between groups in viral respiratory or plasma load between admission and day 7. CONCLUSION: In critically ill patients admitted for SARS-CoV-2-related pneumonia, no difference was found between hydroxychloroquine or lopinavir/ritonavir as compared to standard of care only on the proportion of patients who needed treatment escalation at day 28. Further randomized controlled trials are required to demonstrate whether these drugs may be useful in this context. SN - 1466-609X UR - https://www.unboundmedicine.com/medline/citation/32653015/Comparison_of_hydroxychloroquine_lopinavir/ritonavir_and_standard_of_care_in_critically_ill_patients_with_SARS_CoV_2_pneumonia:_an_opportunistic_retrospective_analysis_ DB - PRIME DP - Unbound Medicine ER -