Phase 3 Long COVID Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Group 1 (up to 500 people):

• The person must be 18 years of age or older.
• There must be written proof of a positive SARS-CoV-2 test taken at least 6 months before the screening visit, including the person's name, the test date (after January 2020), and confirmation that it was a COVID-19 test.
• A study clinician must confirm that the person has Long COVID, meaning at least one new or worsened symptom since their COVID-19 infection that is not explained by another condition — such as fatigue, brain fog, chest pain, muscle aches, shortness of breath, dizziness, nausea, or similar symptoms from a defined list.
• The Long COVID symptoms must have been present for at least 6 months before the screening visit (symptoms that come and go still count if they first appeared at least 6 months ago).
• The symptoms must affect the person's quality of life or daily functioning and be at least somewhat bothersome.
• The person must show signs of cognitive (thinking or memory) difficulties, based on a specific questionnaire where at least 20% of items are rated as subjectively worse or much worse than before.
• The person must be willing and able to sign a consent form after being fully informed about the study.

Group 2 (up to 50 people):

• The person must be 18 years of age or older.
• A clinician must have diagnosed the person with COVID-19 between January 2020 and September 1, 2021 (before home tests were widely available), based on recognised symptom criteria — such as at least two symptoms including fever, chills, muscle aches, headache, sore throat, or loss of smell/taste; or at least one of cough, shortness of breath, or breathing difficulty; or severe respiratory illness such as pneumonia — with no other more likely explanation.
• A study clinician must confirm that the person has Long COVID, with at least one new or worsened symptom from the same defined list as Group 1, not explained by another condition.
• The Long COVID symptoms must have been present for at least 6 months before the screening visit.
• The symptoms must affect the person's quality of life or daily functioning and be at least somewhat bothersome.
• The person must show signs of cognitive difficulties, based on the same questionnaire used for Group 1.
• The person must be willing and able to sign a consent form after being fully informed about the study.

Who may not be able to join:

• People whose Long COVID symptoms can be fully explained by a chronic illness that was diagnosed before their Long COVID began (such as ME/CFS or a similar condition linked to a prior infection).
• People who had cognitive (thinking or memory) problems before COVID-19 that were not made worse by COVID-19, as determined by the study clinicians.
• People whose cognitive, physical, or psychological difficulties are severe enough to prevent them from taking part in the study, as assessed by the investigator.
• People assessed as being at moderate or high risk of suicidal thoughts or behaviour, based on a specific rating scale used by the study team.
• People who have had a major heart attack or stroke in the 3 months before joining the study.
• People currently taking baricitinib or certain medicines used to treat autoimmune or inflammatory conditions (called DMARDs) — though some medications in this category with minimal immune effects, such as hydroxychloroquine (Plaquenil), short courses of steroids (under 2 weeks), or minocycline, are not disqualifying.
• People with a known allergy to any ingredient in baricitinib.
• People who have already taken part in this study, or who have been in another study involving baricitinib in the past 30 days.
• People who have tested positive for SARS-CoV-2 on a PCR or rapid antigen test in the 14 days before screening.
• People who have had a blood clot in a vein (such as deep vein thrombosis or pulmonary embolism) in the past 6 months, or who the investigator considers to be at increased risk of blood clots.
• People with a current or recent cancer or blood-related cancer that has not been in remission for at least 5 years (certain localised, fully treated skin cancers are not disqualifying).
• People who were admitted to an intensive care unit (ICU) for treatment of their original acute COVID-19 illness.
• People whose kidneys are not functioning well enough, based on a specific blood test result falling below a set threshold (confirm with trial site).
• People whose blood test results show certain white blood cell counts are too low (confirm with trial site for specific thresholds).
• People whose blood tests show signs of severe liver disease, including elevated bilirubin, or liver enzyme levels above set thresholds (confirm with trial site).
• People whose blood tests show certain liver or muscle enzyme levels are too high (confirm with trial site for specific thresholds).
• People whose haemoglobin (a measure of red blood cells) is below a certain level, confirmed on repeat testing (confirm with trial site).
• People whose platelet counts (cells involved in blood clotting) are too low or too high, confirmed on repeat testing (confirm with trial site).
• People whose fasting cholesterol or LDL ("bad" cholesterol) levels are above set thresholds, confirmed on repeat testing (confirm with trial site).
• People who test positive for Hepatitis B surface antigen or Hepatitis B core antibody (including those who also have a positive Hepatitis B surface antibody, due to risk of the virus reactivating).
• People who currently have active Hepatitis C infection (people who have been successfully treated or have cleared Hepatitis C are not disqualified).
• People who have had a shingles (herpes zoster) outbreak with visible skin sores in the 3 months before screening, or who have a history of shingles or herpes simplex infection that spread widely or caused serious complications.
• People with untreated latent (inactive) tuberculosis, or any active tuberculosis whether treated or not (people with a prior positive TB skin test but a negative QuantiFERON-TB Gold Plus blood test and a history of BCG vaccination may still be eligible — confirm with trial site).
• People who currently have, or have had in the past 30 days, a serious infection such as sepsis or a significant bacterial, viral, fungal, or parasitic infection, as determined by the investigator.
• People living with HIV may not be eligible if they have been on HIV treatment for less than one year, have a CD4+ immune cell count below a certain level, or have had a detectable HIV viral load on two consecutive tests within the past year (confirm with trial site for specific thresholds).
• People who are considered immunocompromised (having a weakened immune system) according to national COVID-19 guidelines and who, in the investigator's opinion, face an unacceptable level of risk from participating.
• People who are currently taking part in another interventional research study, or who have done so in the 30 days before screening.
• People who, in the investigator's opinion, are unlikely to be able to reliably attend follow-up visits or follow the study's procedures and requirements.
• People of childbearing potential under age 55 who are unwilling or unable to either abstain from sex or use at least one acceptable form of contraception from the time of screening through at least 28 days after the study treatment ends (acceptable methods include condoms or diaphragm with spermicide, intrauterine devices, oral contraceptive pills, other contraceptives, or surgical sterilisation).
• People who are unwilling to receive counselling about the risks related to pregnancy or breastfeeding during the study.
• People who are currently pregnant, breastfeeding, or planning to become pregnant or to breastfeed during the study period.
• People who are currently breastfeeding and unwilling to stop for the duration of the trial.
• People who are currently incarcerated.

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