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New hope for long COVID heart sufferers: drug combo trial launches

NCT ID NCT05619653

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a combination of anti-inflammatory and heart-protecting drugs can reduce symptoms and heart damage in people with Long COVID who have ongoing heart inflammation. About 279 adults with heart inflammation seen on MRI will receive either the drug combo or a placebo for several months. The goal is to see if this treatment can improve heart function and reduce symptoms like chest pain and shortness of breath.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

279 people

The number who actually took part.

Started

Dec 2022

Expected to finish

Mar 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.

Ages

18 to 65 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: * Patients ≥ 18 years * Patients with documented recent COVID19 infection (\>4 weeks) * PASC Syndrome, defined by persistence or new symptoms, not present prior to the infection. * CMR evidence of inflammatory cardiac involvement at BL by any of the following criteria: * Increased native T1≥ 1130 ms at 3.0 Tesla (or 1030 ms at 1.5 Tesla) and/or; * Increased native T2 ≥39.5 ms at 3.0 Tesla (or 49.5 at 1.5 Tesla) and/or * present non-ischaemic myopericardial LGE and/or; * LVEF ≥45 - ≤50%. * Willingness to comply with the study procedures and study protocol Exclusion Criteria: * Severe acute COVID illness requiring hospitalisation * Known allergy to or intolerance of the study medications * Symptomatic hypotension (systolic blood pressure less than 90 mm Hg), not reversible with oral hydration * Any previous or current use of ACE inhibitors, AR Blockers * Any previous oral prednisolone, or any other immunosuppressive or biological treatment (within prior 10 weeks) * History or CMR evidence of pre-existing significant heart disease, including: 1. Known cardiac impairment with LVEF ≤44% 2. Congestive heart failure (NYHA III-IV) 3. Active heart failure treatment 4. Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease 5. Persistent or permanent atrial fibrillation or significant heart rhythm abnormalities 6. Congenital or clinically relevant valvular heart disease (moderate or severe) 7. Specific cardiomyopathy (hypertrophic, hypertensive heart disease, amyloidosis, previous myocarditis, non-ischaemic dilated cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, non-compaction cardiomyopathy, etc). * Known significant concomitant diseases that are likely to interfere with the evaluation of the patient's safety and of the study outcome (e.g. diabetes, lung or hepatic disease, epilepsy, psychiatric disorders, renal disease with a current estimated GFR \<30 mL/min/1.73 m² using MDRD formula, chronic systemic infection or immunocompromise) * Exceeding scanner bore and table-holding capacity: Weight \>125 kg, BMI \> 35 kg/m2 * Contraindications to contrast-enhanced CMR imaging, e.g. 1. MR-unsafe implantable device 2. known allergy to gadolinium-based contrast agent (CBGA) * For female participants: 1. Pregnant or breastfeeding women 2. Persons of childbearing potential not willing to use effective contraception (defined as PEARL index \<1 - e.g. contraceptive pill, IUD) * Known alcohol, drug or chemical abuse * Patients currently participating in an investigational study or for whom participation is planned. * Unable to provide written informed consent Patients with CMR evidence of structural heart disease or incidental heart rhythm abnormalities will be advised to see their own doctor for further investigation.

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Conditions

The condition(s) this trial relates to.

coronary microvascular disorder left ventricular failure long COVID-19 Microvascular Angina myocarditis pericarditis Vascular Remodeling vasculitis Ventricular Dysfunction, Left Ventricular Remodeling

As listed by the trial registrant

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

Contacts and locations

Locations

  • Institute for experimental and translational cardiovascular imaging

    Frankfurt am Main, Hesse, 60596, Germany

  • University Hospital Greifswald

    Greifswald, 17475, Germany

  • University Hospital Schleswig-Holstein, Campus KIEL

    Kiel, 24105, Germany

  • University Hospital Ulm

    Ulm, 89081, Germany

  • University Medical Centre Vienna

    Vienna, 1090, Austria

More trials for these conditions

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