Phase 3 Long COVID Trial, Recruiting NCT06928272 Sponsor: Douglas D. Fraser Condition: Long COVID
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Phase 3 Long COVID Trial, Recruiting

NCT06928272
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 to 65 years old
  • People who had a COVID-19 infection at some point in the past four years, either confirmed by a PCR or nucleocapsid antibody test, by a prior positive rapid antigen test, or by having had symptoms consistent with COVID-19 along with known exposure to a confirmed case
  • People who have been diagnosed with Long COVID, meaning symptoms that continued or newly appeared at least 3 months after a COVID-19 infection, have lasted at least 2 months, have no other explanation, and were not present before the COVID-19 infection — this diagnosis may come from a healthcare professional experienced in Long COVID or the trial site investigator
  • People who are currently experiencing at least one of the following self-reported symptoms more days than not: fatigue, breathing problems, circulation issues, memory or thinking or communication difficulties, or muscle and/or joint problems
  • People who are willing and able to follow the study procedures throughout the trial
  • People who are able to give their informed consent to participate

Who may not be able to join:

  • People who are pregnant, breastfeeding, or planning to become pregnant during the study period
  • People of childbearing potential who are unwilling or unable to use at least one acceptable form of contraception (such as condoms with spermicide, an IUD, hormonal contraception, oral contraceptive pills, or surgical sterilisation) from screening through at least 30 days after the study ends, or who are unwilling to receive counselling about pregnancy-related risks
  • Male participants whose partner could become pregnant, unless both parties use reliable contraception during the study and for 30 days after the last dose, and the male participant agrees to use a condom during sexual activity with a partner who could become pregnant
  • People with significantly reduced kidney function (confirm with trial site)
  • People with moderate to severe liver problems based on blood test results (confirm with trial site)
  • People with low red blood cell levels (anaemia) based on blood test results (confirm with trial site)
  • People with low levels of certain white blood cells (neutrophils or lymphocytes) confirmed by repeat testing (confirm with trial site)
  • People with elevated liver enzyme (alkaline phosphatase) levels at three times or more above the normal range (confirm with trial site)
  • People with elevated creatine phosphokinase levels at three times or more above the normal range (confirm with trial site)
  • People with a platelet count that is too low or too high, confirmed by repeat testing (confirm with trial site)
  • People with high fasting total cholesterol (280 mg/dL or above) confirmed by repeat testing
  • People with high fasting LDL cholesterol (180 mg/dL or above) confirmed by repeat testing
  • People with a personal or family history of a heart rhythm condition called long QT syndrome, or whose screening heart tracing (ECG) shows a QTc interval of 500 milliseconds or more
  • People with an HIV diagnosis
  • People with active hepatitis B or C (note: successfully treated or cleared hepatitis C is not a barrier)
  • People who have had an active shingles (herpes zoster) outbreak with visible skin sores within the past 3 months, or who have any history of a severe or widespread herpes zoster or herpes simplex infection
  • People with active or latent tuberculosis
  • People whose immune system is significantly weakened, to a degree the investigator considers an unacceptable risk for participation
  • People with an active cancer or blood/lymph system disorder that has not been in remission for at least five years (note: certain treated skin cancers are not a barrier)
  • People who have tested positive for COVID-19 in the last 30 days, or who are currently experiencing COVID-19-like symptoms
  • People who were previously admitted to an intensive care unit (ICU) for treatment of acute COVID-19
  • People with any history of deep vein thrombosis, pulmonary embolism, unstable angina, atrial fibrillation, ventricular fibrillation, heart attack, or stroke
  • People who have had sepsis or a significant infection (viral, bacterial, fungal, or parasitic) within the 30 days before enrolment
  • People who have used any of the study drugs within the 30 days before enrolment
  • People with known allergies to any components of the study drugs
  • People who have ever previously used medications known as JAK inhibitors
  • People who are currently taking any medication on the trial's prohibited medications list (confirm with trial site for the full list)
  • People who are currently taking or planning to take any of the following supplements: Taurine, Curcumin, CoQ10, Creatine, Resveratrol, Fisetin, Nicotinamide mononucleotide (NMN), NAD+, Quercetin, Glycine, Spermidine, Arginine alpha-ketoglutarate, Ergothioneine, Alpha Lipoic Acid, Carnitine, Benfotiamine, Carnosine, Crocin, or N-acetylcysteine
  • People who have received a COVID-19 vaccine within the 30 days before enrolment, or plan to receive any live vaccine during the study period
  • People who have received any other vaccine (including flu vaccine) within 14 days before enrolment
  • People who have had major surgery within the 30 days before enrolment, or who plan to have major surgery during the study
  • People with any other medical condition or medication use that the study investigators believe could affect participant safety or the accuracy of study results
  • People who have participated in another clinical trial within the last 30 days
  • People who participated in Phase One of this study (LC-Revitalize)
  • People who are currently hospitalised or incarcerated

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Douglas D Fraser, MD, PhD, FRCPC, Western University

Phone: 1-519-685-8500

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Douglas D. Fraser
Registry
ClinicalTrials.gov
Start date
10 September 2025
Est. completion
1 December 2026

Where this trial is recruiting

🇧🇷 Brazil 🇨🇦 Canada 🇮🇹 Italy Uganda 🇺🇸 United States Zambia

Primary endpoints

Symptom Burden Questionnaire (SBQ) Subscales

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov