Evusheld (cilgavimab/tixagevimab) / AstraZeneca - LARVOL DELTA

Effectiveness of early intervention and combination treatment with monoclonal antibodies and antivirals in oncohematological patients with SARS-CoV-2: a retrospective experience. (PubMed, Front Immunol) - "We focused on the impact in patients with COVID-19 related pneumonia of specific therapies, early treatment, and tixagevimab-cilgavimab prophylaxis on in-hospital mortality and viral clearance time...This group also showed a significant reduction in the time to viral clearance from the first day of the evaluated therapy (6 days [IQR 4;9]), compared to patients treated with only remdesivir (17 days [IQR 8;37]) (p=0.03)...These results, in line with recent studies, underscore the critical importance of prompt treatment and a multitargeted pharmacological approach for optimizing outcomes in oncohematological patients with SARS-CoV-2. Future research, involving larger cohorts, should delve deeper into COVID-19 treatment strategies for this vulnerable population, with a particular emphasis on the elderly, who continue to experience high mortality rates."

Journal • Retrospective data • Hematological Disorders • Infectious Disease • Novel Coronavirus Disease • Oncology • Pneumonia • Respiratory Diseases

Effectiveness of full mRNA vaccinations to prevent COVID-19 among immunocompromised patients receiving tixagevimab-cilgavimab as pre-exposure prophylaxis. (PubMed, J Formos Med Assoc) - "The Kaplan-Meier estimate showed a lesser trend of breakthrough infections with those receiving full vaccinations (P = 0.08). Our study underscores the importance of full vaccinations among immunocompromised patients receiving pre-exposure prophylactic mAbs against COVID-19."

Journal • Hematological Disorders • Hematological Malignancies • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases

De Novo DSA and Antibody-Mediated Rejection in Heart Transplant Patients After COVID-19 or Evusheld Administration: A Case Series (ISHLT 2025) - "Patient outcomes and responses to therapies such as plasmapheresis and rituximab were documented.Results Of the nine patients, six developed AMR within 1 year of transplantation following COVID-19 infection or Evusheld administration, while three developed late AMR. The findings underscore the need for vigilant monitoring and timely intervention in transplant recipients who experience COVID-19 or receive prophylactic monoclonal antibody therapies. These cases highlight the importance of managing viral infections aggressively to prevent immune activation and graft injury in this vulnerable population."

Clinical • Antibody-mediated Rejection • Infectious Disease • Novel Coronavirus Disease • Transplantation • NPPB

AstraZeneca showcases innovation in infectious disease protection at ESCMID Global 2025 (AstraZeneca Press Release) - "AstraZeneca will share new data across its Vaccines & Immune Therapies portfolio at the 2025 Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global 2025) in Vienna, Austria, from 11-15 April 2025. With 13 abstracts, including two oral presentations and two late-breaking poster presentations, the Company will highlight progress in advancing novel immunisations against bacterial and viral infectious diseases and share real-world evidence showing the burden of respiratory viral infections and the continued need for protection."

Clinical data • Preclinical • Bronchiectasis • Infectious Disease • Influenza • Respiratory Diseases

ACUTE FIBRINOUS AND ORGANIZING PNEUMONIA AND NONSPECIFIC INTERSTITIAL PNEUMONIA ASSOCIATED WITH ALLOGENIC HEMATOPOIETIC STEM CELL TRANSPLANTATION. CASES REPORT (EBMT 2025) - "A 36-year-old man with AML underwent allo-HSCT on 08.06.23 from a matched unrelated donor after RIC (fludarabine/busulfan) and prophylaxis of GVHD with Cy 100 mg/kg, MMF, CSА...Second allo-HSCT was on 19.07.23 from a haploidentical father with a treosulfan-based regimen...BAL was pathogen-negative, and empirical ceftaroline therapy was initiated.Despite treatment, respiratory failure progressed, requiring high-flow oxygen...Antimicrobial therapy was adjusted (trimethoprim/sulfamethoxazole, piperacillin/tazobactam, moxifloxacin, and "Evusheld"). Prednisolone (1 mg/kg/day) and FAM were started on 01.12.2023 with partial improvement.SARS-CoV-2 was detected, and molnupiravir was administered...Ruxolitinib (20 mg/day) was started on 22.01.2024, leading to improvement observed on subsequent CT scans...Antimicrobial therapy (voriconazole, meropenem, levofloxacin, polymyxin) stabilized her condition... We report two cases of rare ILDs: AFOP and NSIP. Currently, there..."

Case report • Clinical • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Cough • Graft versus Host Disease • Immunology • Infectious Disease • Interstitial Lung Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • Transplantation

New Function for Safety Signal Monitoring in MID-NET®: The Case of an Anti-COVID-19 Drug. (PubMed, Clin Transl Sci) - "We monitored the safety signals of an anti-COVID-19 drug (combination of tixagevimab and cilgavimab) and compared them with those of two controls (peramivir and the combination of casirivimab and imdevimab) to examine the practical utility of this new tool. Our study provided helpful information (e.g., new safety signals) on many outcomes at multiple time points, which could enhance the understanding of drug safety profiles soon after approval. Our function can be used to rapidly and continuously monitor drug safety signals and contribute to strengthening drug safety monitoring in Japan."

Journal • Infectious Disease • Novel Coronavirus Disease

Clinical outcomes of immunocompromised patients using tixagevimab-cilgavimab as pre-exposure prophylaxis for COVID-19: real-world experience in Taiwan (ESCMID Global 2025) - No abstract available

Clinical • Clinical data • Real-world • Real-world evidence • Infectious Disease • Novel Coronavirus Disease

Pharmacokinetics and immunogenicity of AZD7442 (Tixagevimab/Cilgavimab) in hospitalised COVID-19 patients: results from the DisCoVeRy trial (ESCMID Global 2025) - No abstract available

Clinical • PK/PD data • Infectious Disease • Novel Coronavirus Disease

Tixagevimab/cilgavimab or placebo for COVID-19 in ACTIV-2: Safety, pharmacokinetics and neutralizing and anti-drug antibodies. (PubMed, iScience) - "SARS-CoV-2 neutralizing antibodies increased 157-fold at 7 days and 127-fold at 1 month (IM-treated) but were less robust in IV participants. These data can inform future development of monoclonal antibodies against SARS-CoV-2 and other viruses, even if this intervention is of low utility for contemporary SARS-CoV-2 variants."

Journal • PK/PD data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Effectiveness of pharmacological treatments for COVID-19 due to SARS-CoV-2: a systematic literature review. (PubMed, Front Pharmacol) - "Regarding the composite of Covid-19-related hospitalization or death from any cause, the drugs with the greatest evidence of efficacy are remdesivir, nirmatrelvir/ritonavir and sotrovimab (although, currently the effectiveness of monoclonal antibodies against the new variants of the virus has not been demonstrated). According to this systematic review, the treatments with the greatest evidence of reducing mortality in patients with COVID-19 are remdesivir and tocilizumab."

Journal • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Impact of SARS-CoV-2 variant mutations on susceptibility to monoclonal antibodies and antiviral drugs: a non-systematic review, April 2022 to October 2024. (PubMed, Euro Surveill) - "We included publications on nirmatrelvir and ritonavir, remdesivir and tixagevimab and cilgavimab, regdanvimab, casirivimab and imdevimab, and sotrovimab approved by the European Medicines Agency (EMA) by 1 October 2024.ResultsThe mutations identified in the open reading frame (ORF)1ab, specifically nsp5:H172Y, nsp5:H172Y and Q189E, nsp5:L50F and E166V and nsp5:L50F, E166A and L167V, led to a decrease in susceptibility to nirmatrelvir and ritonavir, ranging from moderate (25-99) to high reductions (> 100). Tixagevimab and cilgavimab exhibited highly reduced neutralisation activity against BQ.1, BQ.1.1, XBB, XBB.1.5 and BA.2.86 sub-lineages.ConclusionsThe emergence of new variants, some with altered antigenic characteristics, may lead to resistance against mAbs and/or antiviral drugs and evasion of immunity induced naturally or by vaccination. This summary of mutations, combination of mutations and SARS-CoV-2 variants linked to reduced susceptibility to mAbs and..."

Journal • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • SPECC1

Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study (clinicaltrials.gov) - P2/3 | N=3882 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

SARS-COV-2 Pre-Exposure Prophylaxis With Tixagevimab-Cilgavimab in Haematological, Immunocompromised Patients in the Omicron Era. (PubMed, Eur J Haematol) - "Our data showed that tixagevimab-cilgavimab prophylaxis effectively reduces severe COVID-19 outcomes in patients with HM, particularly within the first six months, even during the Omicron era. However, those with recent B-cell depletion (within 12 months) remained at high risk."

Journal • Hematological Disorders • Hematological Malignancies • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases

Efficacy and safety of sipavibart for prevention of COVID-19 in individuals who are immunocompromised (SUPERNOVA): a randomised, controlled, double-blind, phase 3 trial. (PubMed, Lancet Infect Dis) - P2/3 | "The primary analysis showed efficacy and safety of sipavibart in preventing symptomatic COVID-19 in participants who are immunocompromised when susceptible (ie, non-Phe456Leu-containing) variants dominated, although no efficacy was shown against resistant (ie, Phe456Leu-containing) variants that dominate as of November, 2024."

Journal • P3 data • Cardiovascular • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Monoclonal Antibodies in Prevention and Early Treatment of COVID-19 in Lung Transplant Recipients: A Systematic Review and Perspective on the Role of Monoclonal Antibodies in the Future. (PubMed, Transpl Int) - "Moreover, mAb therapy appeared safe and could be a viable option against other pathogens, a route that warrants further investigation. https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=382133, identifier CRD42022382133."

Journal • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Solid Organ Transplantation • Transplantation

Tixagevimab-cilgavimab for the prevention of COVID-19: real-world experience in patients with rheumatic diseases receiving rituximab. (PubMed, Clin Exp Rheumatol) - "TIX-CIL was well tolerated and effective in reducing the incidence of COVID-19 in the subsequent 3 months."

Journal • Real-world evidence • Infectious Disease • Inflammatory Arthritis • Musculoskeletal Diseases • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Respiratory Diseases • Rheumatology

Prophylactic efficacy of tixagevimab/cilgavimab in patients with hematological neoplasms: a single-center study (PubMed, Rinsho Ketsueki) - "Since April 2023, when a Tix/Cil-resistant variant became dominant (frequency >70%), the incidence of breakthrough infections increased from 4% to 35%, and none responded to Tix/Cil. Vaccination, together with daily precautions against infection, is the current approach used to prevent COVID-19, particularly in patients with lymphoid malignancies, because Tix/Cil is no longer effective as prophylaxis."

Journal • Retrospective data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Multiple Myeloma • Novel Coronavirus Disease • Oncology • Respiratory Diseases

Long-term outcomes of passive immunotherapy for COVID-19: A pooled analysis of a large multinational platform randomized clinical trial. (PubMed, Clin Microbiol Infect) - P3 | "In our large study of long half-life passive immunotherapy for hospitalized patients with COVID-19, we did not find evidence of a long-term effect on either mortality or rehospitalization."

Clinical • Journal • Retrospective data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Comparison of immune responses to SARS-CoV-2 spike following Omicron infection or Omicron BA.4/5 vaccination in kidney transplant recipients. (PubMed, Front Immunol) - "Tixagevimab/Cilgavimab treatment was associated with robust neutralization of the Wuhan strain, but ineffective against XBB.1.5...Conversely, omicron infection boosted T cells and humoral responses more effectively, showing efficacy against XBB.1.5. These findings suggest that infection-induced immunity associates with greater protection than vaccination against future variants in KTRs."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Transplantation

Evusheld Japan PMS_Japan Post-Marketing Surveillance (PMS) (clinicaltrials.gov) - P=N/A | N=366 | Completed | Sponsor: AstraZeneca | Recruiting ➔ Completed | N=700 ➔ 366 | Trial completion date: Mar 2026 ➔ Sep 2024 | Trial primary completion date: Mar 2026 ➔ Sep 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Duration of infectious virus shedding of SARS-CoV-2 Omicron variant among immunocompromised patients. (PubMed, J Infect Chemother) - "Long-term viral shedding should be closely monitored in severely immunocompromised patients with COVID-19."

Journal • Hematological Disorders • Hematological Malignancies • Human Immunodeficiency Virus • Immunology • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases • Solid Tumor

Adaptive clinical trial of AZD7442 and SARS-CoV-2 vaccination in immunosuppressed patients highly vulnerable to infection with SARS-CoV-2 virus (RAPID-PROTECTION): protocol for a multicentre, interventional open-label, randomised controlled trial. (PubMed, BMJ Open) - "Findings will be disseminated through peer-reviewed journals and presented at scientific conferences. ISRCTN53507177."

Clinical • Clinical protocol • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Antiviral effect of Evusheld in COVID-19 hospitalized patients infected with pre-omicron or omicron variants: a modelling analysis of the randomized DisCoVeRy trial-authors' response. (PubMed, J Antimicrob Chemother) - No abstract available

Journal • Infectious Disease • Novel Coronavirus Disease

Severe COVID-19 Infection in Patients with Chronic Lymphocytic Leukemia or Indolent B-Cell Non-Hodgkin Lymphoma Who Received Pre-Exposure Prophylaxis with Tixagevimab and Cilgavimab in Italy: Preliminary Results of the Observational Study By the Gimema Working Party on Chronic Lymphoproliferative Disorders and By the Fondazione Italiana Linfomi (ASH 2024) - P | "These patients respond poorly to vaccination, especially those receiving anti-CD20 monoclonal antibodies, Bruton tyrosine kinase inhibitors (BTKi) or the BCL2 inhibitor venetoclax...At 6 months from PrEP, 159/513 patients (31%) had a COVID-19 infection and 39% of these patients received an anti-viral treatment with nirmatrelvir/ritonavir or remdesivir...Noteworthy, 17/18 cases of severe COVID infection occurred in a period (August 2022-January 2023) in which the Omicron sub-variants BA.5 and BQ.1 were prevalent in Italy. In conclusion, in this population of CLL and iB-NHL at high risk for poor response to vaccination, the modern management strategy that included PrEP with tixagevimab and cilgavimab and treatment with antiviral drugs resulted in low rates of severe COVID infection and death."

Clinical • Observational data • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Infectious Disease • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Oncology • Respiratory Diseases • Waldenstrom Macroglobulinemia

Acute kidney injury and tacrolimus toxicity in a kidney transplant recipient treated with nirmaltrevir/ritonavir: a case report. (PubMed, J Med Case Rep) - "This acute kidney injury was attributed to tacrolimus toxicity resulting from a drug-drug interaction with Paxlovid. While transplant recipients have an increased risk of severe disease, current Australian guidelines recommend against Paxlovid use in adults taking medications that are heavily dependent on CYP3A4 for clearance, including calcineurin and mammalian target of rapamycin inhibitors."

Journal • Acute Kidney Injury • Infectious Disease • Nephrology • Novel Coronavirus Disease • Pain • Renal Disease • Respiratory Diseases • Transplantation • CYP3A4