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Can a thymus gland protein shield dialysis patients from COVID-19?

NCT ID NCT04428008

Prevention Sponsor: William B. Ershler, MD 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Phase 2 trial tested whether thymalfasin, a synthetic version of a natural immune-boosting protein, could prevent COVID-19 infection in 189 kidney dialysis patients. These patients are at high risk due to weakened immune systems and frequent clinic visits. The study measured how many got infected, were hospitalized, or died.

What this could mean

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

Active substance
Thymalfasin (Thymosin alpha 1, Ta1)
What this could lead to
If it works, this could point toward a way to protect vulnerable dialysis patients from COVID-19 infection.
What could go wrong
This is a small, early Phase 2 pilot trial, so results may not be definitive. The drug may not reduce infection rates or severity as hoped.

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

189 people

The number who actually took part.

Started

Jan 2021

Finished

Jan 2023

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 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: * Age 18 or greater * Signed informed consent * End-stage renal disease (ESRD) who receive hemodialysis 2 or more times each week and are expected to continue on dialysis indefinitely. Exclusion Criteria: * Patients on short-term hemodialysis, such as those with transient renal dysfunction associated with acute illness who are projected to have return in renal function * Patients for whom renal transplantation is anticipated within the next six months * Patients with an anticipated survival of less than 3 months * Patients with symptoms that might be attributable to COVID-19 infection * Patients who test positive for SARS-CoV2 * Patients with active infectious disease requiring antibiotics * Patients with hospitalization within the previous 3 months for acute myocardial infarction or congestive heart failure * Patients with advanced malignancy receiving cytotoxic chemotherapy * Patients with a Karnofsky Performance Scale score of less than 60 * Patients with prior history of solid organ (kidney, liver, heart, lung, pancreas) or bone marrow transplant * Patients with active autoimmune disease on immunosuppressive medication * Patients receiving Plaquenil * Participation in an investigational drug or device trial in previous 30 days * History of allergy or intolerance to Ta1 * Any other medical or psychiatric condition that, in the opinion of the Investigator, would compromise patient safety or interfere with the objectives of the protocol or completion of the protocol treatment

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Conditions

The condition(s) this trial relates to.

end stage renal failure COVID-19 prevention target

As listed by the trial registrant

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

COVID -19

Contacts and locations

Locations

  • Clinical Research Consultants

    Kansas City, Kansas, 64111, United States

More trials for these conditions

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