RECRUITING

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

Conditions

Long COVID Post-Covid-19 Condition Covid-19 SARS-CoV-2

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

LC-REVITALIZE - A Long Covid Repurposed Drug Study

Quick Facts

Study Start:2025-09-10

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06928272

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	1. Participants who do not meet the criteria outlined above 2. Participants who are unable to provide their informed consent 3. Participants who are pregnant, lactating, or plan to become pregnant during the time of the study 4. 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. 5. 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. 6. eGFR \<30 mL/min/1.73m2 7. Moderate to severe liver dysfunction, defined as Bilirubin \> 1.5 x ULN or AST or ALT \> 2 x ULN 8. Hemoglobin (Hbg) \< 8.0 g/dL 9. Absolute neutrophil count (ANC) below 1,000 cells/mm³, confirmed with repeat testing 10. Absolute lymphocyte count (ALC) below 500 cells/mm³ 11. Alkaline phosphatase (ALP) levels equal to or greater than three times the upper limit of normal (ULN) 12. Creatine phosphokinase (CPK) levels equal to or greater than three times the ULN 13. Platelet count below 100,000 cells/mm³, confirmed with repeat testing 14. Platelet count above 500,000 cells/mm³, confirmed with repeat testing 15. Total fasting cholesterol levels of 280 mg/dL or higher, confirmed with repeat testing 16. Fasting low-density lipoprotein (LDL) levels of 180 mg/dL or higher, confirmed with repeat testing 17. 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 18. Participants with HIV diagnosis 19. Participants with active hepatitis B or C diagnosis. Note: treated or cleared hepatitis C is not exclusionary. 20. 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) 21. Participants with active or latent tuberculosis 22. Immunocompromised status, as determined by the investigator, that places the participant at an unacceptable risk for study participation 23. 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. 24. Positive SARS-CoV-2 test in the last 30 days or symptomatic with Covid-19 like illness 25. Previous admission to an intensive care unit (ICU) for the treatment of acute COVID-19 infection 26. Any history of deep venous thrombosis, pulmonary embolism, unstable angina, atrial fibrillation, ventricular fibrillation, or myocardial infarction or stroke 27. History of sepsis or a significant viral, bacterial, fungal, or parasitic infection within 30 days prior to enrollment, as determined by the investigator. 28. Use of one or more of the study drugs within 30 days prior to enrollment for the original indication or other purposes 29. Known allergic reactions to the components of the study drugs 30. Any prior exposure to JAK inhibitors 31. Taking any of the listed medications on the prohibited medications list in Appendix A 32. Intake or planned consumption of any of the following: Taurine, Curcumin, CoQ10, Creatine, Resveratrol, Fisetin, Nicotinamide mononucleotide (NMN), Nicotinamide adenine dinucleotide (NAD+), Quercetin, Glycine, Spermidine, Arginine alpha-ketoglutarate, Ergothioneine, Alpha Lipoic Acid, Carnitine, Benfotiamine, Carnosine, Crocin, N-acetylcysteine 33. Covid vaccinations are prohibited within 30 days prior to enrollment 34. Live vaccine within the 30 days before enrollment or plan to receive live vaccines during the study period 35. Other vaccines, including influenza vaccine, are prohibited within 14 days of enrollment 36. Major surgery within 30 days prior to enrollment or plans for major surgery during the study 37. 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 interfere with the meaning of the clinical and research measurements as judged by the study investigators 38. Participation in any clinical study within the last 30 days prior to enrollment 39. Participants who participated in Phase One of this study (LC-Revitalize) are not eligible to participate in Phase Two 40. Currently hospitalized and/or incarcerated

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

1. Participants who do not meet the criteria outlined above
2. Participants who are unable to provide their informed consent
3. Participants who are pregnant, lactating, or plan to become pregnant during the time of the study
4. 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.
5. 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.
6. eGFR \<30 mL/min/1.73m2
7. Moderate to severe liver dysfunction, defined as Bilirubin \> 1.5 x ULN or AST or ALT \> 2 x ULN
8. Hemoglobin (Hbg) \< 8.0 g/dL
9. Absolute neutrophil count (ANC) below 1,000 cells/mm³, confirmed with repeat testing
10. Absolute lymphocyte count (ALC) below 500 cells/mm³
11. Alkaline phosphatase (ALP) levels equal to or greater than three times the upper limit of normal (ULN)
12. Creatine phosphokinase (CPK) levels equal to or greater than three times the ULN
13. Platelet count below 100,000 cells/mm³, confirmed with repeat testing
14. Platelet count above 500,000 cells/mm³, confirmed with repeat testing
15. Total fasting cholesterol levels of 280 mg/dL or higher, confirmed with repeat testing
16. Fasting low-density lipoprotein (LDL) levels of 180 mg/dL or higher, confirmed with repeat testing
17. 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
18. Participants with HIV diagnosis
19. Participants with active hepatitis B or C diagnosis. Note: treated or cleared hepatitis C is not exclusionary.
20. 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)
21. Participants with active or latent tuberculosis
22. Immunocompromised status, as determined by the investigator, that places the participant at an unacceptable risk for study participation
23. 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.
24. Positive SARS-CoV-2 test in the last 30 days or symptomatic with Covid-19 like illness
25. Previous admission to an intensive care unit (ICU) for the treatment of acute COVID-19 infection
26. Any history of deep venous thrombosis, pulmonary embolism, unstable angina, atrial fibrillation, ventricular fibrillation, or myocardial infarction or stroke
27. History of sepsis or a significant viral, bacterial, fungal, or parasitic infection within 30 days prior to enrollment, as determined by the investigator.
28. Use of one or more of the study drugs within 30 days prior to enrollment for the original indication or other purposes
29. Known allergic reactions to the components of the study drugs
30. Any prior exposure to JAK inhibitors
31. Taking any of the listed medications on the prohibited medications list in Appendix A
32. Intake or planned consumption of any of the following: Taurine, Curcumin, CoQ10, Creatine, Resveratrol, Fisetin, Nicotinamide mononucleotide (NMN), Nicotinamide adenine dinucleotide (NAD+), Quercetin, Glycine, Spermidine, Arginine alpha-ketoglutarate, Ergothioneine, Alpha Lipoic Acid, Carnitine, Benfotiamine, Carnosine, Crocin, N-acetylcysteine
33. Covid vaccinations are prohibited within 30 days prior to enrollment
34. Live vaccine within the 30 days before enrollment or plan to receive live vaccines during the study period
35. Other vaccines, including influenza vaccine, are prohibited within 14 days of enrollment
36. Major surgery within 30 days prior to enrollment or plans for major surgery during the study
37. 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 interfere with the meaning of the clinical and research measurements as judged by the study investigators
38. Participation in any clinical study within the last 30 days prior to enrollment
39. Participants who participated in Phase One of this study (LC-Revitalize) are not eligible to participate in Phase Two
40. Currently hospitalized and/or incarcerated

Contacts and Locations

Study Contact

Stephanie Perkin

CONTACT

1-519-685-8500

stephanie.perkin@lhsc.on.ca

Principal Investigator

Douglas D Fraser, MD, PhD, FRCPC

PRINCIPAL_INVESTIGATOR

Western University

Study Locations (Sites)

Laura Rodriguez Research Institute

San Diego, California, 92101

United States

Collaborators and Investigators

Sponsor: Douglas D. Fraser

Douglas D Fraser, MD, PhD, FRCPC, PRINCIPAL_INVESTIGATOR, Western University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-10

Study Completion Date2027-12

Study Record Updates

Study Start Date2025-09-10

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

Post-Covid-19 Condition
Covid-19
SARS-CoV-2

Additional Relevant MeSH Terms

Long COVID