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ESCAPE: An Open-Label Trial of Personalized Immunotherapy in Critically lll COVID-19 Patients.
Karakike, Eleni; Dalekos, George N; Koutsodimitropoulos, Ioannis; Saridaki, Maria; Pourzitaki, Chryssa; Papathanakos, Georgios; Kotsaki, Antigone; Chalvatzis, Stamatios; Dimakopoulou, Vasiliki; Vechlidis, Nikolaos; Paramythiotou, Elisabeth; Avgoustou, Christina; Ioakeimidou, Aikaterini; Kouriannidi, Elli; Komnos, Apostolos; Neou, Evangelia; Rovina, Nikoletta; Stefanatou, Eleni; Milionis, Haralampos; Nikolaidis, George; Koutsoukou, Antonia; Damoraki, Georgia; Dimopoulos, George; Zoumpos, Vassileios; Eugen-Olsen, Jesper; Akinosoglou, Karolina; Gatselis, Nikolaos K; Koulouras, Vasilios; Gkeka, Eleni; Markou, Nikolaos; Netea, Mihai G; Giamarellos-Bourboulis, Evangelos J.
  • Karakike E; Fourth Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
  • Dalekos GN; Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, General University Hospital of Larissa, Larissa, Greece.
  • Koutsodimitropoulos I; Intensive Care Unit of Latseion Burn Center, General Hospital of Eleusis Thriasion, Eleusis, Greece.
  • Saridaki M; Fourth Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
  • Pourzitaki C; Intensive Care Unit, AHEPA Thessaloniki General Hospital, Thessaloniki, Greece.
  • Papathanakos G; Department of Critical Care Medicine, University of Ioannina, School of Health Sciences, Faculty of Medicine, Ioannina, Greece.
  • Kotsaki A; Fourth Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
  • Chalvatzis S; Fourth Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
  • Dimakopoulou V; Department of Internal Medicine, University of Patras, Medical School, Rion, Greece.
  • Vechlidis N; Fourth Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
  • Paramythiotou E; Second Department of Critical Care Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
  • Avgoustou C; Fourth Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
  • Ioakeimidou A; Intensive Care Unit, Asklipeion General Hospital, Voula, Greece.
  • Kouriannidi E; Fourth Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
  • Komnos A; Intensive Care Unit, Koutlimpaneion-Triantafylleion Larissa General Hospital, Larissa, Greece.
  • Neou E; Intensive Care Unit, Koutlimpaneion-Triantafylleion Larissa General Hospital, Larissa, Greece.
  • Rovina N; First Department of Pulmonary Medicine and Intensive Care Unit, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
  • Stefanatou E; Intensive Care Unit of Latseion Burn Center, General Hospital of Eleusis Thriasion, Eleusis, Greece.
  • Milionis H; First Department of Internal Medicine, University of Ioannina, School of Health Sciences, Faculty of Medicine, Ioannina, Greece.
  • Nikolaidis G; Intensive Care Unit, Asklipeion General Hospital, Voula, Greece.
  • Koutsoukou A; First Department of Pulmonary Medicine and Intensive Care Unit, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
  • Damoraki G; Fourth Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
  • Dimopoulos G; Second Department of Critical Care Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
  • Zoumpos V; Fourth Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
  • Eugen-Olsen J; Clinical Research Centre, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.
  • Akinosoglou K; Department of Internal Medicine, University of Patras, Medical School, Rion, Greece.
  • Gatselis NK; Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, General University Hospital of Larissa, Larissa, Greece.
  • Koulouras V; Department of Critical Care Medicine, University of Ioannina, School of Health Sciences, Faculty of Medicine, Ioannina, Greece.
  • Gkeka E; Intensive Care Unit, AHEPA Thessaloniki General Hospital, Thessaloniki, Greece.
  • Markou N; Intensive Care Unit of Latseion Burn Center, General Hospital of Eleusis Thriasion, Eleusis, Greece.
  • Netea MG; Department of Internal Medicine and Center for Infectious Diseases, Radboud University, Nijmegen, The Netherlands.
  • Giamarellos-Bourboulis EJ; Immunology and Metabolism, Life & Medical Sciences Institute, University of Bonn, Bonn, Germany.
J Innate Immun ; : 1-11, 2021 Dec 01.
Article in English | MEDLINE | ID: covidwho-1546612
Preprint
This scientific journal article is probably based on a previously available preprint. It has been identified through a machine matching algorithm, human confirmation is still pending.
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ABSTRACT

BACKGROUND:

Macrophage activation-like syndrome (MALS) and complex immune dysregulation (CID) often underlie acute respiratory distress (ARDS) in COVID-19. We aimed to investigate the effect of personalized immunotherapy on clinical improvement of critical COVID-19.

METHODS:

In this open-label prospective trial, 102 patients with ARDS by SARS-CoV-2 were screened for MALS (ferritin >4,420 ng/mL) and CID (ferritin ≤4,420 ng/mL and low human leukocyte antigen (HLA)-DR expression on CD14-monocytes). Patients with MALS or CID with increased aminotransferases received intravenous anakinra; those with CID and normal aminotransferases received tocilizumab. The primary outcome was ≥25% decrease in the Sequential Organ Failure Assessment (SOFA) score and/or 50% increase in the respiratory ratio by day 8; 28-day mortality, change of SOFA score by day 28, serum biomarkers, and cytokine production by mononuclear cells were secondary endpoints.

RESULTS:

The primary study endpoint was met in 58.3% of anakinra-treated patients and in 33.3% of tocilizumab-treated patients (p 0.01). Most patients in both groups received dexamethasone as standard of care. No differences were found in secondary outcomes, mortality, and SOFA score changes. Ferritin decreased among anakinra-treated patients; interleukin-6, soluble urokinase plasminogen activator receptor, and HLA-DR expression increased among tocilizumab-treated patients. Survivors by day 28 who received anakinra were distributed to lower severity levels of the WHO clinical progression scale. Greater incidence of secondary infections was found with tocilizumab treatment.

CONCLUSION:

Immune assessment resulted in favorable anakinra responses among critically ill patients with COVID-19 and features of MALS.
Keywords

Full text: Available Collection: International databases Database: MEDLINE Type of study: Randomized controlled trials Language: English Journal: J Innate Immun Journal subject: Allergy and Immunology Year: 2021 Document Type: Article Affiliation country: 000519090

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Randomized controlled trials Language: English Journal: J Innate Immun Journal subject: Allergy and Immunology Year: 2021 Document Type: Article Affiliation country: 000519090