Phase 2 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:

• People aged 18 up to (but not including) 70 years old.
• People who have had at least one confirmed COVID-19 infection, proven by a positive PCR test or a positive rapid antigen test — a suspected infection without a confirmed test result is not sufficient.
• People whose Long COVID has been confirmed by the study doctor.
• People experiencing at least 2 symptoms (or at least 1 very severe symptom) from a specific list that are new or got worse after a COVID-19 infection, and that the study doctor does not believe are caused by something else. These symptoms may include: tiredness or exhaustion, worsening of symptoms after activity, chills, memory or concentration problems ("brain fog"), headaches, dizziness or unsteadiness, nerve pain, sleep problems, chest pain, heart palpitations, shortness of breath, cough, fainting, muscle aches, joint pain, nausea, or diarrhoea.
• People whose Long COVID symptoms have been present for at least 60 days before the screening visit.
• People whose symptoms are at least somewhat bothersome and affect daily life or quality of life.
• People for whom at least 90 days have passed since their most recent confirmed COVID-19 infection, at the time of screening.
• People who are not currently in hospital.
• People with a body mass index (a measure of body weight relative to height) between 18 and 50 at the time of screening.
• People who are in otherwise stable overall health, as assessed by the study doctor within the 28 days before screening.
• Male participants whose female partners of childbearing potential must agree to use effective contraception from the start of the study through 7 months after the last dose; and those with pregnant partners must agree to use condoms during vaginal intercourse from study entry through 14 days after the last dose.
• Female participants who are not pregnant and not breastfeeding; if of childbearing potential, contraception must be used from 21 days before the first dose through at least 7 months after the last dose, and a negative pregnancy test is required within 24 hours before each dose.
• People who are willing and able to follow the study schedule, including attending all visits and having reliable transport.
• People who are able to give written informed consent.

Who may not be able to join:

• People who have received a COVID-19 antiviral or monoclonal antibody treatment within 30 days before the planned first dose, or who plan to receive such treatment before finishing the study.
• People who plan to receive any COVID-19 vaccine or booster within 14 days before the first dose, or before finishing the study.
• People with a history of an autoimmune disease, such as coeliac disease, rheumatoid arthritis, psoriasis, or inflammatory bowel disease.
• People with certain active heart or cardiovascular conditions, including a heart attack within 90 days of screening, heart bypass surgery within 90 days of screening, current heart failure with reduced pumping function, or current pulmonary arterial hypertension (high blood pressure in the lungs).
• People who have had a stroke within 3 months before the planned first dose.
• People with an active bacterial, fungal, viral, or other infection (other than COVID-19) that requires treatment and shows signs of affecting the whole body, within 14 days before the first dose.
• People who have had major surgery within 3 months before the planned first dose, or who have major surgery planned within the first 75 days after the first dose.
• People who had an unplanned hospital stay of more than 24 hours within 28 days before screening.
• People with a current or past Hepatitis B infection, based on specific blood test results — prior Hepatitis B is also exclusionary even if no longer active.
• People with an active Hepatitis C infection; people whose Hepatitis C has been fully cured (shown by a negative Hepatitis C RNA test) may still be eligible (confirm with trial site).
• People with certain abnormal blood test results, including low white blood cell counts, low platelet counts, low haemoglobin (anaemia), elevated liver enzyme levels, or reduced kidney function below a specific threshold.
• People with a known or suspected HIV infection.
• People with end-stage kidney disease requiring dialysis.
• People with Type 1 or Type 2 diabetes who require medication or insulin to manage it.
• People with severe liver disease (classified as Child-Pugh Class C).
• People with moderate or severe immune system problems, which includes those currently being treated for cancer with chemotherapy, those who have had a solid organ transplant and are on immune-suppressing medication, those who have had CAR-T cell therapy or a stem cell transplant within the past 2 years or are still on immune-suppressing treatment, people with primary immune deficiency conditions, or people taking high-dose steroid medication (at least 20mg of prednisone or equivalent, daily, for 2 or more weeks).
• People who had a diagnosis of chronic fatigue syndrome (ME/CFS) before their COVID-19 infection, where that condition is not related to COVID-19 and has not worsened since their infection.
• People who had a diagnosis of dysautonomia (a condition affecting the body's automatic functions, such as heart rate and blood pressure) before their COVID-19 infection, where that condition is not related to COVID-19 and has not worsened since their infection.
• People with a known allergy to any ingredient in the study treatment.
• People with a history of severe allergic reactions (such as anaphylaxis) to medications or foods, or who have severe allergic conditions as assessed by the study doctor.
• People who have taken part in another clinical trial and received an experimental treatment within 28 days before the planned first dose (an exception may apply for certain Long COVID imaging studies — confirm with trial site).
• People whose alcohol or drug use, in the study doctor's assessment, would prevent safe participation.
• People with any other condition that the study doctor believes would put them at risk or affect the reliability of the study results.

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