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A study to evaluate the effectiveness of upadacitinib and pirfenidone in reducing symptom severity in patients with Long Covid

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Long Covid, a condition where symptoms persist for a long time after an initial infection. The purpose of the study is to evaluate the efficacy of study drugs in improving symptom severity in participants. The medications being investigated include upadacitinib and pirfenidone. Some participants will receive these active medicines, while others will receive a placebo.

During the study, the effects of these treatments will be observed across various areas of health, such as fatigue, breathing, memory, thinking, communication, muscles, joints, and circulation. The course of the study involves monitoring changes in these symptoms over time. Additionally, researchers will look at blood biomarkers, which are natural substances found in the blood that can indicate how the body is functioning, as well as plasma proteomics and plasma metabolomics, which are specialized tests used to study proteins and metabolites to understand the biological processes occurring in the body.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study participation and medication administration

    The participation begins with the administration of assigned medications to address long covid symptoms.

    One option involves taking rinvoq, which is a 15 mg prolonged-release tablet, taken by mouth.

    Another option involves taking pirfenidon, which is a 267 mg film-coated tablet, with a total daily dose of 2403 mg taken by mouth.

    The medications may be the active study drugs or a placebo, which is an inactive substance that looks like the medicine but has no active ingredient.

  2. Step 2

    Symptom monitoring and assessment

    The severity of symptoms is monitored using various scales to evaluate fatigue, breathing, memory, thinking, and communication, muscles and joints, and circulation.

    Questionnaires are completed to measure the overall symptom burden, including assessments for anxiety and depression symptoms.

    Physical changes are measured through an exercise capacity test, which involves walking a specific distance in six minutes.

  3. Step 3

    Safety and biological monitoring

    Safety is monitored by tracking any adverse events, which are unwanted or harmful medical occurrences, and any laboratory abnormalities.

    Blood samples are analyzed to check for changes in biomarkers, which are measurable substances in the body that indicate health status.

    Advanced blood tests called plasma proteomics and plasma metabolomics are performed to study how the body's proteins and metabolism respond to the medication.

Who can join the trial?

7 criteria

  • You must be an adult between the ages of 18 and 65.
  • You must have had Covid-19 (an infection caused by the SARS-CoV-2 virus) within the last four years. This can be confirmed by a positive PCR test (a laboratory test used to detect the virus), a positive antigen test (a rapid test that detects specific proteins of the virus), or by having antibodies (proteins produced by the immune system to fight a specific virus) in your blood.
  • You must be diagnosed with Long Covid, which means you have had symptoms for at least 3 months after your initial infection, and these symptoms have lasted for at least 2 months without another medical explanation.
  • The symptoms must have started after your Covid-19 infection and must occur more often than not.
  • At the time of the initial evaluation, you must be experiencing at least one of the following: fatigue (extreme tiredness), breathing difficulties, circulation issues (problems with blood flow), memory, thinking, or communication difficulties, or muscle and joint pain.
  • You must be able and willing to follow all the steps and rules of the study for the entire duration.
  • You must be able to provide informed consent, which means you understand the details of the study and agree to participate.

Who cannot join the trial?

38 criteria

  • You do not meet the basic requirements needed to join the study.
  • Your absolute lymphocyte count, which is a measure of certain white blood cells that help fight infection, is too low (below 500 cells/mm³).
  • Your alkaline phosphatase levels, a type of liver and bone enzyme, are three times higher than the normal limit.
  • Your creatine phosphokinase levels, an enzyme found in the heart, brain, and muscles, are three times higher than the normal limit.
  • Your platelet count, which helps your blood clot, is either too low (below 100,000 cells/mm³) or too high (above 500,000 cells/mm³).
  • Your total fasting cholesterol levels are 280 mg/dL or higher.
  • Your fasting LDL, often called "bad" cholesterol, is 180 mg/dL or higher.
  • You have a history of long QT syndrome, which is a heart rhythm problem, or your electrocardiogram (ECG), a test that records heart activity, shows a specific electrical delay.
  • You have been diagnosed with HIV.
  • You have an active hepatitis B or hepatitis C infection, though having had it in the past and being cured is okay.
  • You are unable to give informed consent, which is your formal agreement to participate after understanding the study.
  • You have had a herpes zoster (shingles) infection with visible sores in the last 3 months, or a history of serious nerve-related infections caused by herpes.
  • You have active or hidden tuberculosis.
  • You have an immunocompromised status, meaning your immune system is weakened and you are at higher risk for infections.
  • You have an active malignancy (cancer) or a blood disorder that has not been in remission (a period where there are no signs of disease) for at least five years.
  • You have tested positive for SARS-CoV-2 (the virus that causes Covid-19) in the last 30 days or have symptoms of Covid-19.
  • You have previously been admitted to the intensive care unit (ICU) to treat severe Covid-19.
  • You have a history of blood clots in the veins, lung clots, heart rhythm issues, heart attack, or stroke.
  • You have had sepsis (a life-threatening reaction to infection) or a significant infection in the 30 days before joining.
  • You have used any of the study drugs in the 30 days before joining.
  • You have a known allergy to any part of the study drugs.
  • You are pregnant, breastfeeding, or planning to become pregnant during the study.
  • You have ever used JAK inhibitors, which are a specific type of medicine.
  • You are taking any medications that are on the study's prohibited list.
  • You are taking or plan to take certain supplements like Taurine, Curcumin, CoQ10, Creatine, or many others listed in the study rules.
  • You received a Covid vaccination in the 30 days before joining.
  • You received a live vaccine in the 30 days before joining or plan to receive one during the study.
  • You received other vaccines, such as the flu vaccine, in the 14 days before joining.
  • You had major surgery in the 30 days before joining or plan to have surgery during the study.
  • You have any other medical condition or are taking any other medicine that the doctors believe might make the study unsafe or interfere with the results.
  • You participated in another clinical study in the last 30 days.
  • You already participated in Phase One of this specific study.
  • You are unwilling to use effective contraception (methods to prevent pregnancy, such as birth control pills or condoms) to prevent pregnancy during and after the study.
  • You are currently in the hospital or in prison.
  • Your eGFR, a measure of how well your kidneys filter blood, is below 30 mL/min/1.73m2.
  • You have moderate to severe liver dysfunction, meaning your liver is not working correctly.
  • Your hemoglobin, a protein in red blood cells that carries oxygen, is below 8.0 g/dL.
  • Your absolute neutrophil count (ANC), a type of white blood cell that fights bacteria, is below 1,000 cells/mm³.
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Investigated drugs

  • Rinvoq

    is a medication taken by mouth that is being tested to see if it can help reduce the severity of symptoms in people living with Long Covid.

  • Pirfenidone

    is a medication taken by mouth that is being studied to determine if it can help improve the symptoms experienced by patients with Long Covid.

What is already known about the treatment

  • Upadacitinib

    This medication is taken by mouth in the form of a long-acting tablet. It is an approved medicine used to treat various inflammatory conditions by blocking specific proteins inside cells that signal the immune system to cause swelling and pain. Known as a JAK inhibitor, it works by stopping certain chemical messengers that trigger inflammation throughout the body.

  • Pirfenidone

    This drug is administered orally as a film-coated tablet. It is an established treatment used to manage certain lung conditions by reducing the formation of scar tissue. Functioning as an anti-fibrotic agent, it works at a molecular level to slow down the processes that cause excessive tissue scarring and inflammation.

  • Microcrystalline cellulose

    This substance is taken by mouth and is used in clinical studies as a placebo, which means it has no active medicinal effect. It is a common, inactive ingredient used widely in the medical industry to help form the shape of pills and tablets. Because it does not trigger any biological response, it serves as a neutral control to compare against active medications.

Investigated diseases

Long Covid - This condition involves a variety of lingering symptoms that persist after an initial viral infection. It can affect multiple bodily systems, including the respiratory, neurological, and circulatory systems. Common experiences include ongoing fatigue, breathing difficulties, and issues with memory or concentration. Some individuals also report muscle and joint pain or changes in blood circulation. The severity and specific symptoms can vary significantly from person to person.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522611-42-00Protocol codeLC-RevitalizeEstimated enrolment348 patientsSponsorDr. Douglas D. Fraser

sourced from the EU Clinical Trials Register and site verification

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