RSV, Influenza, and SARS-CoV-2 Outcomes in Severely Immunosuppressed Adults

NCT07816471 | Active Not Recruiting

• 2 other identifiers: 77382025010848
• Study Type: observational
• Target: 350
• Locations: 0 countries
• Sites: N/A

Brief Summary

Respiratory syncytial virus (RSV), influenza, and SARS-CoV-2 are common respiratory viruses. In healthy adults they usually cause mild, cold-like illness, but in people whose immune system is severely weakened - such as people who have had a bone marrow, stem cell, or organ transplant, people being treated for cancer or blood disorders, or people taking medicines that suppress the immune system - these infections can be much more serious, sometimes spreading from the nose and throat down into the lungs and leading to hospitalization, intensive care, or death. This study looks back at medical records from a large hospital network in Buenos Aires, Argentina, covering two periods (November 2011 to March 2020, and May 2022 to December 31, 2025) to describe what happens to adults with severely weakened immune systems after they are diagnosed with RSV, influenza, or SARS-CoV-2. For each of these three viruses, researchers will separately describe how sick patients were on the day of diagnosis and again 7 and 30 days later; whether the infection spread from the upper airway down into the lungs; how often patients needed to be hospitalized or admitted to an intensive care unit; how long hospital stays lasted; and how many patients died within 30 days. The study will also look for patient characteristics - such as the type of immune weakness, low blood cell counts, or vaccination status - that are linked to worse outcomes within each virus group. The three viruses are described separately and are not statistically compared against one another. This is a review of existing medical record information only. No new tests, procedures, or treatments will be given to patients as part of the study, and no patient will be contacted; all information comes from data already collected during routine medical care. This study is conducted under a research agreement with Pfizer.

Conditions

Respiratory Syncytial Virus Infections; Immunocompromised Host; Influenza; COVID - 19

Keywords

SARS-CoV-2; RSV; Influenza; Acute respiratory viral infection; Immunocompromised host; Severe immunosuppression; Hematopoietic stem cell transplantation; Solid organ transplantation; Neutropenia; Lymphopenia; Viral pneumonia; Multiplex PCR; Intensive care unit admission; 30-day mortality

Outcome Measures

Primary Outcomes (7)

• Ordinal clinical status score

  Clinical status assessed using a 6-category mutually exclusive ordinal scale (Davey et al.): discharged with full recovery; discharged but not back to normal activities; hospitalized without oxygen requirement; hospitalized with oxygen requirement; ICU admission; death. Assessed separately within each of the RSV, influenza, and SARS-CoV-2 cohorts; no formal comparison between cohorts is performed.

  Day 0, Day 7, and Day 30 after diagnosis

• Progression from upper to lower respiratory tract infection

  Proportion of patients initially meeting criteria for upper respiratory tract infection (URTI) who develop new lower respiratory symptoms plus radiologic evidence of new pulmonary lesions.

  Within 48 hours to 30 days of diagnosis

• Hospitalization

  Proportion of patients requiring hospitalization; among patients initially managed as outpatients, hospitalization occurring within 30 days of the positive PCR result.

  Within 30 days of diagnosis

• Length of hospital stay

  Total number of days between hospital admission and discharge (including transfer, discharge, or death), among hospitalized patients.

  Through hospital discharge, up to 30 days

• ICU admission

  Proportion of patients requiring admission to an intensive care unit (intermediate care, adult ICU, or coronary unit) for respiratory or hemodynamic support.

  Within 30 days of diagnosis

• ICU length of stay

  Number of days from ICU admission to discharge from the hospital (transfer to general ward, hospital discharge, transfer to another center, or death).

  Through hospital discharge, up to 30 days

• All-cause 30-day mortality

  Death from any cause within 30 days of the positive PCR result for the respiratory virus.

  30 days after diagnosis

Secondary Outcomes (3)

• Outpatient and emergency department visits

  Within 30 days of diagnosis

• Major cardiovascular events

  Within 366 days of diagnosis

• Predictors of worse clinical outcomes, by virus

  Within 30 days of diagnosis

Study Arms (3)

RSV

Adults with severe immunosuppression and a laboratory-confirmed diagnosis of acute viral respiratory infection due to respiratory syncytial virus (RSV) by multiplex PCR, meeting criteria for upper or lower respiratory tract infection, between November 1, 2011 and March 20, 2020, and from May 1, 2022 to December 31, 2025.

Influenza

Adults with severe immunosuppression and a laboratory-confirmed diagnosis of acute viral respiratory infection due to influenza by multiplex PCR, meeting criteria for upper or lower respiratory tract infection, during the same study period.

SARS-CoV-2

Adults with severe immunosuppression and a laboratory-confirmed diagnosis of acute viral respiratory infection due to SARS-CoV-2 by multiplex PCR, meeting criteria for upper or lower respiratory tract infection, during the same study period.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of all adults treated within the Hospital Italiano de Buenos Aires (HIBA) network - a high-complexity, university-affiliated healthcare system in Buenos Aires, Argentina - who met criteria for severe immunosuppression and had a laboratory-confirmed diagnosis of RSV, influenza, or SARS-CoV-2 by multiplex PCR, between November 1, 2011 and March 20, 2020, and from May 1, 2022 to December 31, 2025. All patient care is documented in a single EHR system, from which the population was identified through automated, retrospective queries, without manual chart review, regardless of care setting (outpatient, emergency department, ward, or ICU).

You may qualify if:

• Presence of severe immunosuppression, defined as any of the following:
• active leukemia or lymphoma;
• disseminated malignancy;
• aplastic anemia;
• graft-versus-host disease (GVHD);
• congenital immunodeficiencies (e.g., common variable immunodeficiency);
• treatment with immune checkpoint inhibitors or recent radiotherapy;
• solid organ transplantation with immunosuppressive therapy;
• immunosuppressive drugs related to transplantation (cyclosporine, tacrolimus, sirolimus, everolimus, azathioprine, mycophenolate mofetil);
• hematopoietic stem cell transplant (HSCT) within two years or ongoing immunosuppressive therapy;
• high-dose systemic corticosteroids (≥20 mg of prednisone/day or equivalent for ≥2 weeks);
• alkylating agents (e.g., cyclophosphamide) or antimetabolites such as methotrexate (\>0.4 mg/kg/week), azathioprine (≥3 mg/kg/day), or 6-mercaptopurine (≥1.5 mg/kg/day);
• chemotherapy agents for cancer;
• TNF-alpha inhibitors (etanercept, adalimumab, certolizumab, golimumab, infliximab);
• biologics or lymphocyte-depleting agents (e.g., thymoglobulin, alemtuzumab); B-cell depleting agents (e.g., rituximab);

You may not qualify if:

• Patients under palliative care or with a life expectancy of less than 24-48 hours.
• Lack of nursing NEWS assessment, or a medical order stating "Do not resuscitate" or "Do not follow NEWS protocol."
• Patients vaccinated with an RSV vaccine prior to the acute respiratory infection episode, based on documented RSV vaccination status in the electronic health record (applicable to the later study period only, May 2022-December 31, 2025, coinciding with RSV vaccine availability in Argentina).

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead
• Pfizer: collaborator

Related Publications (10)

• Davey RT Jr, Fernandez-Cruz E, Markowitz N, Pett S, Babiker AG, Wentworth D, Khurana S, Engen N, Gordin F, Jain MK, Kan V, Polizzotto MN, Riska P, Ruxrungtham K, Temesgen Z, Lundgren J, Beigel JH, Lane HC, Neaton JD; INSIGHT FLU-IVIG Study Group. Anti-influenza hyperimmune intravenous immunoglobulin for adults with influenza A or B infection (FLU-IVIG): a double-blind, randomised, placebo-controlled trial. Lancet Respir Med. 2019 Nov;7(11):951-963. doi: 10.1016/S2213-2600(19)30253-X. Epub 2019 Sep 30.

  PMID: 31582358 BACKGROUND

• Surie D, Yuengling KA, DeCuir J, Zhu Y, Gaglani M, Ginde AA, Talbot HK, Casey JD, Mohr NM, Ghamande S, Gibbs KW, Files DC, Hager DN, Ali H, Prekker ME, Gong MN, Mohamed A, Johnson NJ, Steingrub JS, Peltan ID, Brown SM, Leis AM, Khan A, Hough CL, Bender WS, Duggal A, Wilson JG, Qadir N, Chang SY, Mallow C, Kwon JH, Exline MC, Lauring AS, Shapiro NI, Columbus C, Vaughn IA, Ramesh M, Safdar B, Halasa N, Chappell JD, Grijalva CG, Baughman A, Rice TW, Womack KN, Han JH, Swan SA, Mukherjee I, Lewis NM, Ellington S, McMorrow ML, Martin ET, Self WH; IVY Network. Disease Severity of Respiratory Syncytial Virus Compared with COVID-19 and Influenza Among Hospitalized Adults Aged >/=60 Years - IVY Network, 20 U.S. States, February 2022-May 2023. MMWR Morb Mortal Wkly Rep. 2023 Oct 6;72(40):1083-1088. doi: 10.15585/mmwr.mm7240a2.

  PMID: 37796753 BACKGROUND

• Ackerson B, Tseng HF, Sy LS, Solano Z, Slezak J, Luo Y, Fischetti CA, Shinde V. Severe Morbidity and Mortality Associated With Respiratory Syncytial Virus Versus Influenza Infection in Hospitalized Older Adults. Clin Infect Dis. 2019 Jul 2;69(2):197-203. doi: 10.1093/cid/ciy991.

  PMID: 30452608 BACKGROUND

• Hirsch HH, Martino R, Ward KN, Boeckh M, Einsele H, Ljungman P. Fourth European Conference on Infections in Leukaemia (ECIL-4): guidelines for diagnosis and treatment of human respiratory syncytial virus, parainfluenza virus, metapneumovirus, rhinovirus, and coronavirus. Clin Infect Dis. 2013 Jan;56(2):258-66. doi: 10.1093/cid/cis844. Epub 2012 Sep 28.

  PMID: 23024295 BACKGROUND

• Khawaja F, Chemaly RF. Respiratory syncytial virus in hematopoietic cell transplant recipients and patients with hematologic malignancies. Haematologica. 2019 Jul;104(7):1322-1331. doi: 10.3324/haematol.2018.215152. Epub 2019 Jun 20.

  PMID: 31221784 BACKGROUND

• Nguyen-Van-Tam JS, O'Leary M, Martin ET, Heijnen E, Callendret B, Fleischhackl R, Comeaux C, Tran TMP, Weber K. Burden of respiratory syncytial virus infection in older and high-risk adults: a systematic review and meta-analysis of the evidence from developed countries. Eur Respir Rev. 2022 Nov 15;31(166):220105. doi: 10.1183/16000617.0105-2022. Print 2022 Dec 31.

  PMID: 36384703 BACKGROUND

• Gomez JA, Cintra O, Berzanskis A, Pacheco S, Jaswantlal H, Hasnaoui AE, van Oorschot DAM, Guzman-Holst A. Burden of Disease Due to Respiratory Syncytial Virus in Adults in Five Middle-Income Countries. Infect Dis Rep. 2024 Aug 15;16(4):750-762. doi: 10.3390/idr16040057.

  PMID: 39195008 BACKGROUND

• Havers FP, Whitaker M, Melgar M, Pham H, Chai SJ, Austin E, Meek J, Openo KP, Ryan PA, Brown C, Como-Sabetti K, Sosin DM, Barney G, Tesini BL, Sutton M, Talbot HK, Chatelain R, Daily Kirley P, Armistead I, Yousey-Hindes K, Monroe ML, Tellez Nunez V, Lynfield R, Esquibel CL, Engesser K, Popham K, Novak A, Schaffner W, Markus TM, Swain A, Patton ME, Kim L. Burden of Respiratory Syncytial Virus-Associated Hospitalizations in US Adults, October 2016 to September 2023. JAMA Netw Open. 2024 Nov 4;7(11):e2444756. doi: 10.1001/jamanetworkopen.2024.44756.

  PMID: 39535791 BACKGROUND

• Kenmoe S, Nair H. The disease burden of respiratory syncytial virus in older adults. Curr Opin Infect Dis. 2024 Apr 1;37(2):129-136. doi: 10.1097/QCO.0000000000001000. Epub 2024 Jan 10.

  PMID: 38197402 BACKGROUND

• Diaz Lobo ED, Huaier Arriuazu EF, Vaena M, Hongn D, Molina JDV, Giunta DH, Blugerman GA, Sanchez MDL. Respiratory syncytial virus infection in non-severely immunocompromised adults: Clinical features and outcomes from a tertiary university hospital in Argentina. Enferm Infecc Microbiol Clin (Engl Ed). 2026 Feb;44(2):503076. doi: 10.1016/j.eimce.2026.503076.

  PMID: 41654383 BACKGROUND

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections; Influenza, Human; COVID-19; Neutropenia; Lymphopenia; Pneumonia, Viral

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Orthomyxoviridae Infections; Respiratory Tract Diseases; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start: November 1, 2011
• Primary Completion: December 31, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share