When the immune system Can't fight back: tracking three respiratory viruses

NCT ID NCT07816471

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

350 people

The number who actually took part.

Started

Nov 2011

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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