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New hope for lung transplant patients: drug may block dangerous virus

NCT ID NCT05041426

Prevention Sponsor: Fernanda P Silveira, MD, MS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested the drug letermovir to prevent CMV infection in 15 adults who had a lung transplant for idiopathic pulmonary fibrosis (IPF). Participants took letermovir daily for 6 or 12 months depending on their CMV risk. The goal was to see if the drug could prevent CMV infection during and shortly after treatment. This was a small pilot study with no comparison group, so results are preliminary.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Letermovir (also known as Prevymis)
What this could lead to
If it works, this could offer a safer way to prevent CMV infection after lung transplant, reducing side effects like low white blood cell counts.
What could go wrong
This is a small pilot study with only 15 participants and no control group, so results may not apply broadly. The drug may still cause side effects or fail to prevent CMV.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

15 people

The number who actually took part.

Started

Dec 2021

Finished

Mar 2025

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.

Ages

18 to 100 years

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: * Age ≥18 years on day of signing informed consent * Listed for lung transplantation (single or double) due to a diagnosis of IPF or receipt of a lung transplant (single or double) for IPF in the 72 hours prior to enrollment * Have a documented positive serostatus for CMV (CMV IgG seropositive, R+) * Have a documented negative serostatus for CMV (CMV IgG seronegative, R-) and anticipate receiving or having received a lung allograft from a CMV IgG positive donor, D+). Only participants who are R+ or who are CMV D+/R- will receive intervention. Participants who are CMV D-/R- will be considered screen failures * Able to travel to UPMC for routine post-transplant visits for a minimum of 15 months after transplantation * Able to provide informed consent * Be willing to use a contraceptive method while receiving LET and for at least 90 days following last dose of LET Exclusion Criteria: * Receipt of a previous solid organ transplant or hematopoietic stem cell transplant * Multi-organ transplant recipient, i.e., heart-lung or lung-liver * HIV seropositive * HCV antibody or HCV RNA positive * Donor HCV NAT positive * Anticipated need for use of ganciclovir, valganciclovir, foscarnet, or cidofovir at the time of transplant * Known or suspected hypersensitivity to LET or acyclovir * CrCl \< 10 ml/min or dialysis on day of transplant * Child-Pugh Class C severe hepatic insufficiency * Pregnancy or expected to conceive while on LET and through at least 90 days following cessation of LET

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Conditions

The condition(s) this trial relates to.

cytomegalovirus infection idiopathic pulmonary fibrosis human betaherpesvirus 5 infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CMV Lung transplant

Contacts and locations

Locations

  • UPMC

    Pittsburgh, Pennsylvania, 15213, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.