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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 study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
National Institute For Infectious Diseases Lazzaro Spallanzani Rome Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not yet recruiting
01.12.2025

Trial locations

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.

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 ID:
2025-522611-42-00
Protocol code:
LC-Revitalize
NCT ID:
NCT06928272
Trial Phase:
Therapeutic confirmatory (Phase III)

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