When the immune system Can't fight back: tracking three respiratory viruses
NCT ID NCT07816471
First seen Sep 11, 2026 · Last updated Sep 11, 2026
Summary
Researchers are reviewing medical records from a large hospital network in Buenos Aires to understand what happens to adults with severely weakened immune systems after they catch RSV, influenza, or SARS-CoV-2. The study covers 350 patients and looks at how sick they were at diagnosis, whether the infection spread to the lungs, how often they needed hospitalization or intensive care, and how many died within 30 days. The three viruses are described separately, and the team is also checking which patient traits, such as the type of immune weakness or vaccination status, are linked to worse outcomes. No new tests or treatments are given; all information comes from records already collected during routine care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If the patterns are clear, doctors could better predict which immunocompromised patients face the worst outcomes from RSV, flu, or COVID, and target care earlier.
- What could go wrong
- This is a look back at existing records, so it can show links but not prove cause and effect. Findings from one hospital network in Argentina may not apply everywhere, and missing or inconsistent records could limit what researchers can conclude.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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350 people
The number who actually took part.
- Started
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Nov 2011
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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).
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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); * HIV-positive patients with CD4 count \<200 cells/mm³, AIDS diagnosis, or symptomatic HIV. * Suspected acute viral respiratory infection, defined per European Conference on Infections in Leukemia (ECIL) criteria as meeting all of the following: clinical suspicion recorded in the electronic health record; positive multiplex PCR for RSV, SARS-CoV-2, or influenza; and fulfillment of criteria for either upper (URTI) or lower respiratory tract infection (LRTI). * URTI criteria: presence of at least two of the following - rhinorrhea, nasal or sinus congestion, otitis media, pharyngitis, or dry cough - with a normal chest X-ray or CT scan. * LRTI or new pneumonia criteria: cough accompanied by at least one of the following - dyspnea, rhonchi, crackles, wheezing, tachypnea, or hypoxemia - with a new pulmonary infiltrate on chest X-ray or CT scan. Exclusion Criteria: * 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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Other studies related to the condition(s) this trial covers.
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