684 results match your criteria trial anakinra

Description and Analysis of Cytokine Storm in Registered COVID-19 Clinical Trials: A Systematic Review.

Pathogens 2021 Jun 2;10(6). Epub 2021 Jun 2.

Infectious Disease Unit, Specialty Internal Medicine, Johns Hopkins Aramco Healthcare, Dhahran 31311, Saudi Arabia.

The purpose of this systematic review was to describe the characteristics of clinical trials that focused on COVID-19 patients with cytokine release syndrome (CRS) and the variability in CRS definitions. Two authors independently searched three clinical trial registries and included interventional clinical trials on COVID-19 hospitalized patients that required at least one elevated inflammatory biomarker. Relevant data, including the type and cutoff of the measured biomarker, oxygen/respiratory criteria, fever, radiologic criteria, and medications, were summarized. Read More

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The cytokine storms of COVID-19, H1N1 influenza, CRS and MAS compared. Can one sized treatment fit all?

Cytokine 2021 08 26;144:155593. Epub 2021 May 26.

Deakin University, IMPACT - the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, Geelong, Australia; Department of Psychiatry, King Chulalongkorn University Hospital, Bangkok, Thailand; Department of Psychiatry, Medical University of Plovdiv, Plovdiv, Bulgaria. Electronic address:

An analysis of published data appertaining to the cytokine storms of COVID-19, H1N1 influenza, cytokine release syndrome (CRS), and macrophage activation syndrome (MAS) reveals many common immunological and biochemical abnormalities. These include evidence of a hyperactive coagulation system with elevated D-dimer and ferritin levels, disseminated intravascular coagulopathy (DIC) and microthrombi coupled with an activated and highly permeable vascular endothelium. Common immune abnormalities include progressive hypercytokinemia with elevated levels of TNF-α, interleukin (IL)-6, and IL-1β, proinflammatory chemokines, activated macrophages and increased levels of nuclear factor kappa beta (NFκB). Read More

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Molecular Perspectives of SARS-CoV-2: Pathology, Immune Evasion, and Therapeutic Interventions.

Mol Cells 2021 Jun;44(6):408-421

Department of Physiology, Ajou University School of Medicine, Suwon 16499, Korea.

The outbreak of coronavirus disease 2019 (COVID-19) has not only affected human health but also diverted the focus of research and derailed the world economy over the past year. Recently, vaccination against COVID-19 has begun, but further studies on effective therapeutic agents are still needed. The severity of COVID-19 is attributable to several factors such as the dysfunctional host immune response manifested by uncontrolled viral replication, type I interferon suppression, and release of impaired cytokines by the infected resident and recruited cells. Read More

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A Brief Overview of Recurrent Pericarditis Management and the Potential of Rilonacept as a New Therapeutic Option.

Am J Cardiovasc Drugs 2021 May 19. Epub 2021 May 19.

MedStar Heart and Vascular Institute, Union Memorial Hospital, Baltimore, MD, USA.

Recurrent pericarditis affects 15-30% of patients after acute pericarditis. A large number of the patients with recurrent pericarditis can become corticosteroid dependent, leading to disease chronicity and drug dependence, with additional morbidity from long-term steroid use. Recent randomized trials indicate the efficacy of the interleukin-1 inhibitors anakinra and rilonacept in recurrent pericarditis, including colchicine-resistant and corticosteroid-dependent cases. Read More

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Respiratory Impairment Predicts Response to IL-1 and IL-6 Blockade in COVID-19 Patients With Severe Pneumonia and Hyper-Inflammation.

Front Immunol 2021;12:675678. Epub 2021 Apr 29.

Università Vita-Salute San Raffaele, IRCCS San Raffaele Scientific Institute, Milan, Italy.

Background: Restraining maladaptive inflammation is considered a rationale strategy to treat severe (COVID-19) but available studies with selective inhibitors of pro-inflammatory cytokines have not provided unequivocal evidence of survival advantage. Late administration is commonly regarded as a major cause of treatment failure but the optimal timing for anti-cytokine therapy initiation in COVID-19 patients has never been clearly established.

Objectives: To identify a window of therapeutic opportunity for maximizing the efficacy of interleukin (IL)-1 and IL-6 blockade in COVID-19. Read More

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Efficacy and safety of gout flare prophylaxis and therapy use in people with chronic kidney disease: a Gout, Hyperuricemia and Crystal-Associated Disease Network (G-CAN)-initiated literature review.

Arthritis Res Ther 2021 04 28;23(1):130. Epub 2021 Apr 28.

Division of Rheumatology and Clinical Immunology, University of Alabama, 1720 2nd Avenue South, Birmingham, AL, 35294, USA.

Gout flare prophylaxis and therapy use in people with underlying chronic kidney disease (CKD) is challenging, given limited treatment options and risk of worsening renal function with inappropriate treatment dosing. This literature review aimed to describe the current literature on the efficacy and safety of gout flare prophylaxis and therapy use in people with CKD stages 3-5. A literature search via PubMed, the Cochrane Library, and EMBASE was performed from 1 January 1959 to 31 January 2018. Read More

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Early anti IL-1 treatment replaces steroids in refractory Kawasaki disease: clinical experience from two case reports.

Ther Adv Musculoskelet Dis 2021 29;13:1759720X211002593. Epub 2021 Mar 29.

NEUROFARBA Department, University of Florence, Rheumatology Unit, Meyer Children's University Hospital, Florence, Viale Gaetano Pieraccini, 24, Firenze, 50139, Italy.

Refractory Kawasaki disease (KD) is related to a major risk of coronary arteries abnormalities and its treatment is not standardized. In this regard, anakinra (ANA), an interleukin (IL)-1 receptor antagonist, represents an emerging therapeutic option. We report two cases of children, diagnosed with KD, nonresponsive to two doses of intravenous immunoglobulins, successfully treated with ANA, without a prior use of steroids. Read More

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Effects of interleukin-1 antagonism and corticosteroids on fibroblast growth factor-21 in patients with metabolic syndrome.

Sci Rep 2021 Apr 12;11(1):7911. Epub 2021 Apr 12.

Division of Endocrinology, Diabetes, and Metabolism, University Hospital Basel, Basel, Switzerland.

Fibroblast growth factor-21 (FGF21) is elevated in patients with the metabolic syndrome. Although the exact underlying mechanisms remain ill-defined, chronic low-grade inflammation with increased Interleukin-(IL)-1β expression may be responsible. The aim of this study was to investigate effects of two different anti-inflammatory treatments (IL-1 antagonism or high-dose corticosteroids) on FGF21 in patients with the metabolic syndrome. Read More

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An open label trial of anakinra to prevent respiratory failure in COVID-19.

Elife 2021 03 8;10. Epub 2021 Mar 8.

4th Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.

Background: It was studied if early suPAR-guided anakinra treatment can prevent severe respiratory failure (SRF) of COVID-19.

Methods: A total of 130 patients with suPAR ≥6 ng/ml were assigned to subcutaneous anakinra 100 mg once daily for 10 days. Primary outcome was SRF incidence by day 14 defined as any respiratory ratio below 150 mmHg necessitating mechanical or non-invasive ventilation. Read More

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Benefits of anakinra versus TNF inhibitors in rheumatoid arthritis and type 2 diabetes: long-term findings from participants furtherly followed-up in the TRACK study, a multicentre, open-label, randomised, controlled trial.

Clin Exp Rheumatol 2021 Mar-Apr;39(2):403-406. Epub 2021 Mar 3.

Rheumatology and Immunology Unit, Department of Medicine, University of Rome 'Campus Biomedico', Rome, Italy.

Objectives: Interleukin (IL)-1β is considered a shared pathogenic mediator between rheumatoid arthritis (RA) and type 2 diabetes (T2D). In the TRACK study, participants with both diseases were randomised to an IL-1 inhibitor, anakinra, or a TNF inhibitor (TNFi). After 6 months, anakinra induced a such of improvement on metabolic and inflammatory parameters, leading to a premature stoppage of the study. Read More

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Anakinra for patients with COVID-19: a meta-analysis of non-randomized cohort studies.

Eur J Intern Med 2021 04 5;86:34-40. Epub 2021 Feb 5.

Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan (Italy).

Introduction: Severe COVID-19 cases have a detrimental hyper-inflammatory host response and different cytokine-blocking biologic agents were explored to improve outcomes. Anakinra blocks the activity of both IL-1α and IL‑1β and is approved for different autoinflammatory disorders, but it is used off-label for conditions characterized by an excess of cytokine production. Several studies on anakinra in COVID-19 patients reported positive effects. Read More

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Efficacy of early anti-inflammatory treatment with high doses of intravenous anakinra with or without glucocorticoids in patients with severe COVID-19 pneumonia.

J Allergy Clin Immunol 2021 04 6;147(4):1217-1225. Epub 2021 Feb 6.

IRCCS G. Gaslini, Genoa, Italy. Electronic address:

Background: IL-1 plays a pivotal role in the inflammatory response during cytokine storm syndromes.

Objective: Our aim was to analyze the efficacy and safety of early anti-inflammatory treatment (AIT) with intravenous anakinra with or without glucocorticoids in coronavirus disease 2019 (COVID-19) pneumonia.

Methods: We performed a retrospective single-center cohort study of patients admitted for COVID-19 pneumonia from February 26 to April 29, 2020, to assess the efficacy of early AIT with intravenous anakinra (100 mg every 8 hours for 3 days, with tapering) alone or in combination with a glucocorticoid (intravenous methylprednisolone, 1-2 mg/kg daily, with tapering). Read More

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Surviving Sepsis Campaign Guidelines on the Management of Adults With Coronavirus Disease 2019 (COVID-19) in the ICU: First Update.

Crit Care Med 2021 03;49(3):e219-e234

Warren Alpert School of Medicine at Brown University, Providence, RI.

Background: The coronavirus disease 2019 pandemic continues to affect millions worldwide. Given the rapidly growing evidence base, we implemented a living guideline model to provide guidance on the management of patients with severe or critical coronavirus disease 2019 in the ICU.

Methods: The Surviving Sepsis Campaign Coronavirus Disease 2019 panel has expanded to include 43 experts from 14 countries; all panel members completed an electronic conflict-of-interest disclosure form. Read More

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Pharmacogenomics and COVID-19: clinical implications of human genome interactions with repurposed drugs.

Osama A Badary

Pharmacogenomics J 2021 06 4;21(3):275-284. Epub 2021 Feb 4.

Clinical Pharmacy Practice Department, Faculty of Pharmacy, The British University in Egypt (BUE), Cairo, Egypt.

The outbreak of Coronavirus disease 2019 (COVID-19) has evolved into an emergent global pandemic. Many drugs without established efficacy are being used to treat COVID-19 patients either as an offlabel/compassionate use or as a clinical trial. Although drug repurposing is an attractive approach with reduced time and cost, there is a need to make predictions on success before the start of therapy. Read More

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Effect of anakinra versus usual care in adults in hospital with COVID-19 and mild-to-moderate pneumonia (CORIMUNO-ANA-1): a randomised controlled trial.


Lancet Respir Med 2021 03 22;9(3):295-304. Epub 2021 Jan 22.

Background: Patients with COVID-19 pneumonia have an excess of inflammation and increased concentrations of cytokines including interleukin-1 (IL-1). We aimed to determine whether anakinra, a recombinant human IL-1 receptor antagonist, could improve outcomes in patients in hospital with mild-to-moderate COVID-19 pneumonia.

Methods: In this multicentre, open-label, Bayesian randomised clinical trial (CORIMUNO-ANA-1), nested within the CORIMUNO-19 cohort, we recruited patients from 16 University hospitals in France with mild-to-moderate COVID-19 pneumonia, severe acute respiratory syndrome coronavirus 2 infection confirmed by real-time RT-PCR, requiring at least 3 L/min of oxygen by mask or nasal cannula but without ventilation assistance, a score of 5 on the WHO Clinical Progression Scale (WHO-CPS), and a C-reactive protein serum concentration of more than 25 mg/L not requiring admission to the intensive care unit at admission to hospital. Read More

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Prevention of posttraumatic osteoarthritis at the time of injury: Where are we now, and where are we going?

J Orthop Res 2021 Jun 4;39(6):1152-1163. Epub 2021 Mar 4.

Centre for Osteoarthritis Pathogenesis Versus Arthritis, Kennedy Institute of Rheumatology, NDORMS, University of Oxford, Oxford, UK.

This overview of progress made in preventing post-traumatic osteoarthritis (PTOA) was delivered in a workshop at the Orthopaedics Research Society Annual Conference in 2019. As joint trauma is a major risk factor for OA, defining the molecular changes within the joint at the time of injury may enable the targeting of biological processes to prevent later disease. Animal models have been used to test therapeutic targets to prevent PTOA. Read More

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Anakinra compared to prednisone in the treatment of acute CPPD crystal arthritis: A randomized controlled double-blinded pilot study.

Joint Bone Spine 2021 03 29;88(2):105088. Epub 2020 Oct 29.

Rheumatology Department, Lausanne University Hospital, avenue Pierre-Decker 4, 1005 Lausanne, Switzerland.

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Immunopathogenesis and treatment of cytokine storm in COVID-19.

Theranostics 2021 1;11(1):316-329. Epub 2021 Jan 1.

Department of Pediatrics, Yonsei University College of Medicine, Seoul, Republic of Korea.

Severe coronavirus disease 2019 (COVID-19) is characterized by systemic hyper-inflammation, acute respiratory distress syndrome, and multiple organ failure. Cytokine storm refers to a set of clinical conditions caused by excessive immune reactions and has been recognized as a leading cause of severe COVID-19. While comparisons have been made between COVID-19 cytokine storm and other kinds of cytokine storm such as hemophagocytic lymphohistiocytosis and cytokine release syndrome, the pathogenesis of cytokine storm has not been clearly elucidated yet. Read More

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January 2021

Comparative efficacy and safety of pharmacological interventions for the treatment of COVID-19: A systematic review and network meta-analysis.

PLoS Med 2020 12 30;17(12):e1003501. Epub 2020 Dec 30.

Department of Pharmacology, Pusan National University, School of Medicine, Yangsan, Republic of Korea.

Background: Numerous clinical trials and observational studies have investigated various pharmacological agents as potential treatment for Coronavirus Disease 2019 (COVID-19), but the results are heterogeneous and sometimes even contradictory to one another, making it difficult for clinicians to determine which treatments are truly effective.

Methods And Findings: We carried out a systematic review and network meta-analysis (NMA) to systematically evaluate the comparative efficacy and safety of pharmacological interventions and the level of evidence behind each treatment regimen in different clinical settings. Both published and unpublished randomized controlled trials (RCTs) and confounding-adjusted observational studies which met our predefined eligibility criteria were collected. Read More

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December 2020

Recommendations for Dosing of Repurposed COVID-19 Medications in Patients with Renal and Hepatic Impairment.

Drugs R D 2021 Mar 17;21(1):9-27. Epub 2020 Dec 17.

Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.

Introduction: In December 2019, an outbreak of a novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) began, resulting in a number of antivirals and immune modulators being repurposed to treat the associated coronavirus disease 2019 (COVID-19). Many patients requiring treatment for COVID-19 may have either pre-existing renal or hepatic disease or experience acute renal/hepatic injury as a result of the acute infection. Altered renal or hepatic function can significantly affect drug concentrations of medications due to impaired drug metabolism and excretion, resulting in toxicity or reduced efficacy. Read More

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Anakinra treatment in critically ill COVID-19 patients: a prospective cohort study.

Crit Care 2020 12 10;24(1):688. Epub 2020 Dec 10.

Department of Intensive Care Medicine, Radboud University Medical Center, 6500HB, Nijmegen, The Netherlands.

Background: A subset of critically ill COVID-19 patients develop a hyperinflammatory state. Anakinra, a recombinant interleukin-1 receptor antagonist, is known to be effective in several hyperinflammatory diseases. We investigated the effects of anakinra on inflammatory parameters and clinical outcomes in critically ill, mechanically ventilated COVID-19 patients with clinical features of hyperinflammation. Read More

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December 2020

A randomized, open-label, adaptive, proof-of-concept clinical trial of modulation of host thromboinflammatory response in patients with COVID-19: the DAWn-Antico study.

Trials 2020 Dec 9;21(1):1005. Epub 2020 Dec 9.

Center for Molecular and Vascular Biology, KU Leuven Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium.

Background: The peak of the global COVID-19 pandemic has not yet been reached, and many countries face the prospect of a second wave of infections before effective vaccinations will be available. After an initial phase of viral replication, some patients develop a second illness phase in which the host thrombotic and inflammatory responses seem to drive complications. Severe COVID-19 disease is linked to high mortality, hyperinflammation, and a remarkably high incidence of thrombotic events. Read More

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December 2020

Anakinra: efficacy in the management of fever during neutropenia and mucositis in autologous stem cell transplantation (AFFECT-2)-study protocol for a multicenter randomized double-blind placebo-controlled trial.

Trials 2020 Nov 23;21(1):948. Epub 2020 Nov 23.

Radboud Institute of Health Sciences, Department of Hematology, Radboud University Medical Center, PO Box 9101, 6500, HB, Nijmegen, the Netherlands.

Background: Since decades, fever and infections have been the most important complications of intensive chemotherapy and hematopoietic stem cell transplantation (HSCT) in the treatment of hematologic malignancies. Neutropenia has long been considered to be the most important risk factor for these complications. However, recent studies have shown that not neutropenia, but the development of mucositis is the most important cause of these complications. Read More

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November 2020

Anakinra in hospitalized patients with severe COVID-19 pneumonia requiring oxygen therapy: Results of a prospective, open-label, interventional study.

Int J Infect Dis 2021 Feb 17;103:288-296. Epub 2020 Nov 17.

Department of Medicine, Sultan Qaboos University Hospital, PO Box 35, Alkoudh 123, Muscat, Oman. Electronic address:

Objective: The aim of this study was to evaluate the efficacy of anakinra in patients who were admitted to hospital for severe COVID-19 pneumonia requiring oxygen therapy.

Methods: A prospective, open-label, interventional study in adults hospitalized with severe COVID-19 pneumonia was conducted. Patients in the interventional arm received subcutaneous anakinra (100 mg twice daily for 3 days, followed by 100 mg daily for 7 days) in addition to standard treatment. Read More

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February 2021

Comparison of the efficacy and safety of biological agents in patients with systemic juvenile idiopathic arthritis: A Bayesian network meta-analysis of randomized controlled trials.

Int J Clin Pharmacol Ther 2021 Mar;59(3):239-246

Objective: To assess the relative efficacy and safety of biological agents in patients with systemic juvenile idiopathic arthritis (sJIA).

Materials And Methods: We performed a Bayesian network meta-analysis to combine direct and indirect evidence from randomized controlled trials (RCTs) to examine the efficacy and safety of canakinumab, anakinra, tocilizumab, and rilonacept in patients with sJIA.

Results: Five RCTs that included 286 patients met the inclusion criteria. Read More

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INSAID Variant Classification and Eurofever Criteria Guide Optimal Treatment Strategy in Patients with TRAPS: Data from the Eurofever Registry.

J Allergy Clin Immunol Pract 2021 02 9;9(2):783-791.e4. Epub 2020 Nov 9.

National Amyloidosis Centre, UCL Division of Medicine, Royal Free Campus, University College London, London, United Kingdom. Electronic address:

Background: TNF receptor-associated periodic syndrome (TRAPS) is a rare autoinflammatory disease caused by dominant mutation of the TNF super family receptor 1A (TNFRSF1A) gene. Data regarding long-term treatment outcomes are lacking.

Objective: To assess correlations of genotype-phenotypes in patients with TRAPS, as defined by the International Study Group for Systemic Autoinflammatory Diseases (INSAID) classification and Eurofever criteria, with treatment responses. Read More

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February 2021

Progress report on new antiepileptic drugs: A summary of the Fifteenth Eilat Conference on New Antiepileptic Drugs and Devices (EILAT XV). II. Drugs in more advanced clinical development.

Epilepsia 2020 11 9;61(11):2365-2385. Epub 2020 Nov 9.

Department of Pharmacy, School of Pharmacy, University of Washington, Seattle, WA, USA.

The Fifteenth Eilat Conference on New Antiepileptic Drugs and Devices (EILAT XV) was held as a fully virtual conference from July 27 to July 30, 2020 for the sessions on drugs, and on August 3, 2020 for the sessions on devices. A total of 534 delegates from 63 countries attended lectures and interactive discussions, representing a broad range of disciplines from basic science, clinical research, and clinical care. This progress report provides summaries of recent findings on investigational compounds for which preclinical data as well as data from patient studies were presented. Read More

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November 2020

Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19: A structured summary of a study protocol for a randomised controlled trial.

Trials 2020 Oct 28;21(1):897. Epub 2020 Oct 28.

University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, 22 South Greene Street, Room N9E06, Baltimore, Maryland, 21201, USA.

Objectives: Primary Objective: To evaluate the efficacy and safety of oral administration of imatinib combined with the Best Conventional Care (BCC) versus placebo plus BCC in hospitalized patients with COVID-19.

Hypothesis: Addition of imatinib to the BCC will provide a superior clinical outcome for patients with COVID-19 compared with BCC plus placebo. This hypothesis is on the basis of 1) intralysosomal entrapment of imatinib will increase endosomal pH and effectively decrease SARS-CoV-2/cell fusion, 2) kinase inhibitory activity of imatinib will interfere with budding/release or replication of SARS-CoV-2, and 3) because of the critical role of mechanical ventilation in the care of patients with ARDS, imatinib will have a significant clinical impact for patients with critical COVID-19 infection in Intensive Care Unit (ICU). Read More

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October 2020

Immunomodulatory Therapies for COVID-19 in Solid Organ Transplant Recipients.

Curr Transplant Rep 2020 Oct 23:1-11. Epub 2020 Oct 23.

Unit of Infectious Diseases, Hospital Universitario "12 de Octubre", Instituto de Investigación Sanitaria Hospital "12 de Octubre" (imas12), Centro de Actividades Ambulatorias, 2ª planta, bloque D. Avda. de Córdoba, s/n, 28041 Madrid, Spain.

Purpose Of Review: Severe coronavirus disease 2019 (COVID-19) is characterized by the development of a deleterious hyperinflammatory response, in which the pleiotropic cytokine interleukin (IL)-6 plays a pivotal role. The administration of immunomodulatory therapies has been proposed to revert the tissue damage induced by COVID-19-related cytokine release syndrome (CRS). The present review summarizes the biological rationale and available clinical experience with this therapeutic strategy in the specific scenario solid organ transplantation (SOT). Read More

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October 2020

Immune Therapy, or Antiviral Therapy, or Both for COVID-19: A Systematic Review.

Drugs 2020 Dec;80(18):1929-1946

Rheumatology Unit, Vittorio-Emanuele University Hospital of Catania, Catania, Italy.

Background: Based on current evidence, recent guidelines of the National Institute of Health, USA indicated the use of remdesivir and dexamethasone for the treatment of COVID-19 patients with mild-moderate disease, not requiring high-flow oxygen. No therapeutic agent directed against the immunologic pathogenic mechanisms related to the cytokine release syndrome complicating the disease was indicated.

Objectives: The purpose of this review was to assess the clinical impact of different therapies for COVID-19; thus, helping to identify the optimal management of the disease. Read More

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December 2020