Long Covid (LC)-REVITALIZE - A Long Covid Repurposed Drug Study

What this study is about

The Long-Covid (LC)-Revitalize clinical study is testing repurposed drug treatments for Long Covid, involving adult participants from Brazil, Canada, Italy, Uganda, the United States, and Zambia. To qualify, participants must have had Covid-19 and experienced Long Covid symptoms for at least three months. The main goal of the study is to determine whether the drug treatments can improve symptoms in five key areas: 1) fatigue, 2) breathing, 3) memory, thinking, and communication, 4) muscle and joint pain, and 5) circulation. A secondary goal is to assess changes in the body, such as reducing inflammation, as well as to confirm the safety and tolerability of the treatments. In the first phase, 348 participants will take either one of two existing medications (upadacitinib or pirfenidone) or a placebo (a pill with no active ingredient) for three months. Although these medications are not yet approved for Long Covid, they are authorized for use in treating other health conditions. This study is adaptive, meaning it may adjust based on early results. In the second phase, the study could continue testing the most effective drug(s) against a placebo with new participants, explore combinations of drugs to see if they improve results, or discontinue the drugs if they prove ineffective or unsafe and test alternative treatments.

Who can join (things the study team will check)

✅ You may be able to join if…

• Adults ≥ 18 years of age and ≤ 65 years of age
• Previous Covid-19 (SARS-CoV-2 infection) within the past four years, as determined by the site investigator using the following certainty scale (based on available clinical history and/or serologic data): 3 - Confirmed Infection (PCR or n-Capsid Test): Prior positive nasopharyngeal or salivary PCR test for Covid-19 (documented proof and/or verbal confirmation by participant) or has positive nucleocapsid antibodies results. 2 - Probable Infection (Antigen Test): Participant verbally confirms a prior positive rapid antigen test without PCR confirmation. 1 - Possible Infection (Viral Syndrome and Epidemiological Link): Participant verbally confirms experiencing symptoms consistent with Covid-19 infection and has an epidemiological link (i.e., exposure to a confirmed case) without any positive testing.
• Persistent or new symptoms diagnosed as "Long Covid" as defined by the World Health Organization; "the continuation or development of new symptoms 3 months after the initial SARS-CoV-2 infection (Covid-19), with these symptoms lasting for at least 2 months with no other explanation". This diagnosis may come from a healthcare professional experienced in Long Covid diagnosis, or the site investigator. These symptoms must be present for more days than not and must not have been present prior to the onset of SARS-CoV-2 (Covid-19) infection.
• At the time of screening, participants should be experiencing at least one of the following self-reported symptoms or symptom clusters. Participant has self-reported issues with:
• 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 validated SBQ scales. The selection was driven by their prevalence and their significant impact on quality of life as reported in symptom assessments.
  • Participant has the ability and is willing to follow study procedures throughout the study
  • Participant can provide informed consent

🚫 You may not be able to 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 time of screening through at least 30 days after the end of the study intervention period. Acceptable methods include barrier contraceptives (e.g., condoms or diaphragm) with spermicide, intrauterine devices (IUDs), hormonal contraceptives, oral contraceptive pills, and surgical sterilization. Participants unwilling to be counseled about the risks related to pregnancy or breastfeeding will also be excluded.
• Male participants must take precautions to avoid impregnating a female while participating in this study. If a male participant's partner can become pregnant, she must use an effective and reliable form of birth control, as listed above, during the study and for 30 days after the male participant's last dose of the investigational product. Additionally, male participants must agree to use a latex condom during sexual activity with partners who could become pregnant.
• 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)

+ 20 more criteria — see the full checklist in the app.

Where this trial is running

• Laura Rodriguez Research Institute, San Diego, California, United States
• Ini-Fiocruz, Rio de Janeiro, Rio de Janerio, Brazil
• Institut de Recherches Cliniques de Montréal (IRCM), Montreal, Quebec, Canada
• Centre de Recherche du CHUS (CRCHUS), Sherbrooke, Quebec, Canada
• INMI Lazzaro Spallanzani IRCCS, Roma, Roma, Italy
• Sapienza Università di Roma, Roma, Roma, Italy
• Università degli Studi di Modena e Reggio Emilia, Modena, Italy
• Joint Clinical Research Centre (JCRC), Kampala, Kampala, Uganda
• University Teaching Hospital, Lusaka, Lusaka Province, Zambia

Who to contact

Stephanie Perkin · 1-519-685-8500 · stephanie.perkin@lhsc.on.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06928272.