Long COVID study: Pirfenidone vs Upadacitinib
Official title Long Covid (LC)-REVITALIZE - A Long Covid Repurposed Drug Study
ClinicalTrials.gov ID: NCT06928272
What this study is testing
What is Pirfenidone?
An investigational oral medication being studied as a potential treatment for Long COVID. It is designed to reduce fibrosis and inflammation by inhibiting fibroblast activity and cytokine production.
Also referred to as Esbriet.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out if the drugs can improve fatigue, breathing, thinking, pain, and circulation in people with Long Covid, and to check if they are safe.
- Who it's for
- Adults who had COVID‑19 and still have Long Covid symptoms for at least three months.
- What's involved
- Participants will take either upadacitinib, pirfenidone, or a placebo pill for three months, and will have visits and tests to track symptoms and safety.
- Time commitment
- The study lasts about three months of treatment with regular clinic visits during that time.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Eligible participants must meet all the following
- Adults ≥ 18 years of age and ≤ 65 years of age
- Fatigue
- Breathing
- Circulation
You likely can't join if
- Participants who do not meet the criteria outlined above
- Participants who are unable to provide their informed consent
- Participants who are pregnant, lactating, or plan to become pregnant during the time of the study
- Persons of childbearing potential who are unwilling or unable to abstain from sex or to use at least one acceptable method of contraception from the...
- Male participants must take precautions to avoid impregnating a female while participating in this study.
- eGFR \<30 mL/min/1.73m2
See the full eligibility criteria
- Eligible participants must meet all the following
- Adults ≥ 18 years of age and ≤ 65 years of age
- Fatigue
- Breathing
- Circulation
- Memory, thinking, and/or communication
- Muscles and/or joints These five symptoms or symptom clusters were selected based on unpublished data from the National Institutes for Health and Care Research (NIHR, United Kingdom) and their alignment with five...
- Participants who do not meet the criteria outlined above
- Participants who are unable to provide their informed consent
- Participants who are pregnant, lactating, or plan to become pregnant during the time of the study
- Persons of childbearing potential who are unwilling or unable to abstain from sex or to use at least one acceptable method of contraception from the time of screening through at least 30 days after the end of the study...
- Male participants must take precautions to avoid impregnating a female while participating in this study.
- eGFR \<30 mL/min/1.73m2
- Moderate to severe liver dysfunction, defined as Bilirubin \> 1.5 x ULN or AST or ALT \> 2 x ULN
- Hemoglobin (Hbg) \< 8.0 g/dL
- Absolute neutrophil count (ANC) below 1,000 cells/mm³, confirmed with repeat testing
- Absolute lymphocyte count (ALC) below 500 cells/mm³
- Alkaline phosphatase (ALP) levels equal to or greater than three times the upper limit of normal (ULN)
- Creatine phosphokinase (CPK) levels equal to or greater than three times the ULN
- Platelet count below 100,000 cells/mm³, confirmed with repeat testing
- Platelet count above 500,000 cells/mm³, confirmed with repeat testing
- Total fasting cholesterol levels of 280 mg/dL or higher, confirmed with repeat testing
- Fasting low-density lipoprotein (LDL) levels of 180 mg/dL or higher, confirmed with repeat testing
- A personal or family history of long QT syndrome or an electrocardiogram (ECG) during screening showing a corrected QT interval (QTc) of 500 milliseconds or greater, calculated using Fridericia's formula
- Participants with HIV diagnosis
- Participants with active hepatitis B or C diagnosis. Note: treated or cleared hepatitis C is not exclusionary.
- Active herpes zoster infection (visible skin lesions) within 3 months prior to screening, or any history of disseminated or complicated herpes zoster or herpes simplex infection (e.g., VZV encephalitis)
- Participants with active or latent tuberculosis
- Immunocompromised status, as determined by the investigator, that places the participant at an unacceptable risk for study participation
- Active malignancy or lymphoproliferative disorder that has not been in remission for at least five years. Localized non-melanoma skin cancers that have been definitively treated are not exclusionary.
- Positive SARS-CoV-2 test in the last 30 days or symptomatic with Covid-19 like illness
- Previous admission to an intensive care unit (ICU) for the treatment of acute COVID-19 infection
- Any history of deep venous thrombosis, pulmonary embolism, unstable angina, atrial fibrillation, ventricular fibrillation, or myocardial infarction or stroke
- History of sepsis or a significant viral, bacterial, fungal, or parasitic infection within 30 days prior to enrollment, as determined by the investigator.
- Use of one or more of the study drugs within 30 days prior to enrollment for the original indication or other purposes
- Known allergic reactions to the components of the study drugs
- Any prior exposure to JAK inhibitors
- Taking any of the listed medications on the prohibited medications list in Appendix A
- Intake or planned consumption of any of the following: Taurine, Curcumin, CoQ10, Creatine, Resveratrol, Fisetin, Nicotinamide mononucleotide (NMN), Nicotinamide adenine dinucleotide (NAD+), Quercetin, Glycine...
- Covid vaccinations are prohibited within 30 days prior to enrollment
- Live vaccine within the 30 days before enrollment or plan to receive live vaccines during the study period
- Other vaccines, including influenza vaccine, are prohibited within 14 days of enrollment
- Major surgery within 30 days prior to enrollment or plans for major surgery during the study
- Any other co-existing medical condition or concomitant medication/therapy that might in the judgment of the study investigators, potentially impact the participant's safety or ability to adhere to the study protocol or...
- Participation in any clinical study within the last 30 days prior to enrollment
- Participants who participated in Phase One of this study (LC-Revitalize) are not eligible to participate in Phase Two
- Currently hospitalized and/or incarcerated
The study team makes the final eligibility decision.
Where it is enrolling
- San Diego, California, United States
- Rio de Janeiro, Rio de Janerio, Brazil
- Montreal, Quebec, Canada
- Sherbrooke, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Diego, California, United States; Rio de Janeiro, Rio de Janerio, Brazil; Montreal, Quebec, Canada; Sherbrooke, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.